Tadayon et al.

BMC Medical Informatics and Decision Making (2022) 22:292

[Link]

STUDY PROTOCOL Open Access

Effect of mobile‑based self‑management

application on stroke outcomes: a study
protocol for triple blinded randomized
controlled trial
Hamidreza Tadayon1,2, Mehrdad Farzandipour1,2, Ehsan Nabovati1,2, Hossein Akbari3 and Seyed Ali Masoud4*   

Abstract
Background: Stroke is the main leading cause of long-term disabilities in the world. This protocol will be imple-
mented for a study to evaluate the effects of an Android-based self-care application on patients with stroke.
Methods: The first stage will include the development of an android-based application using JAVA programming
language for developing the user interface and [Link] Core for developing Web server. The second stage will be
conducted using triple blinded randomized clinical trial (RCT). The sample size will include 60 patients with recent
stroke and partial paralysis of limbs, who will be divided into two groups of intervention and control through per-
muted block randomization method. Patients in both groups will receive usual medical care, but those in the inter-
vention group will also use an Android-based application for a period of two months. Outcomes will be assessed
using valid and reliable questionnaires.
Discussion: The assessed outcomes will include stroke severity using National Institute of Health Stroke Scale (NIHSS)
score, ability to perform activities of daily living using Barthel Index (BI) score, depression rate using Beck Depression
Inventory (BDI-II) score, quality of life using EQ-5D-3L score, medication adherence using Modified Morisky Medica-
tion Adherence Scale (MMAS-8) score, patient satisfaction using Patient Satisfaction Questionnaire (PSQ) score and
the number and type of complications in patients in two groups. These outcomes will be assessed at baseline, after
two months and after three months from the beginning of the intervention. Intervention effects on the measured
variables will also be evaluated using appropriate statistical tests based on the type of variable distribution. Potential
consequences of the study might be the improvement of the measured variables in the intervention group com-
pared to that of the control group. The expected results are that the intervention may significantly improve the status
of the measured variables in the intervention group compared to that of the control group. If the outcomes of the
intervention group do not change significantly compared to those of the control group, it can be due to different
reasons. However, this can most likely be attributed to incorrect or insufficient use of the application by patients.
Trial registration: This protocol is registered in the Iranian registration of clinical trial (IRCT) on November 7, 2020 with
the code IRCT20201015049037N1. URL: [Link]

*Correspondence: masoud_s_a@[Link]
4
Department of Neurology, Kashan University of Medical Sciences, 5th Km
Qotb‑e Ravandi Blvd, Kashan, Iran
Full list of author information is available at the end of the article

© The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which
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Tadayon et al. BMC Medical Informatics and Decision Making (2022) 22:292 Page 2 of 12

Keywords: Mobile applications, Self-care, Stroke, Telemedicine, Telerehabilitation

Background activities and social participation. To write this paper,

The incidence of stroke in 2017 (based on findings from the conventional SPIRIT (Standard Protocol Items:
21 regions of the world) was 11.9 million cases, and the Recommendations for Interventional Trials) checklist
disease is the second leading cause of death worldwide and guidance on reporting e-health and m-health tri-
and the main leading cause of long-term disabilities [1]. als written by the CONSORT-EHEALTH (Consolidated
According to the World Health Organization (WHO), Standards of Reporting Trials of Electronic and Mobile
of the 56 million deaths that occur worldwide each year, Health Applications and online Telehealth) group [17]
10.8% are due to stroke [2]. Stroke includes a group of were used.
pathological disorders of cerebral arteries character-
ized by decreased neurological and non-convulsive Methods
function due to cerebral ischemia or intracranial hem- This RCT will be done in two stages. The first stage will
orrhage [3]. Stroke has a variety of consequences for include the development of an android-based applica-
patients [4] and stroke survivors usually experience tion, with the second stage being the evaluation of the
a wide range of symptoms related to motor function, effects of this application on patients with stroke.
speech, swallowing, vision, sensation and perception,
and their recovery can be slow and incomplete [5, 6].
Stage 1: application development
These symptoms often lead to limited participation in
Application development will be based on the model pre-
home and community activities. Rehabilitation proce-
sented by Chavez et al. in 2019 [18] (Fig. 1). This model
dures for these people are often long-term and require
is a combination of iterative and incremental models
a lot of resources. However, only half of survivors have
in system development. According to this model, soft-
access to rehabilitation services after discharge [7]. In
ware development will be done in three different phases,
a qualitative study, Anderson et al. [8] concluded that
which include the following:
mobile-based applications could improve self-care in
patients with chronic conditions. Other studies have
• Determining functional requirements
shown the impacts of mobile-based training on improv-
• Designing a low-fidelity prototype and evaluating its
ing stroke outcomes [9, 10]. An increasing number of
validity
Randomized Clinical Trials (RCTs) have evaluated the
• Designing a high-fidelity prototype and evaluating its
effectiveness of telerehabilitation interventions. Nev-
usability
ertheless, it is difficult to draw conclusions about the
effects of these interventions since the type of inter-
ventions and comparisons performed vary greatly from
study to study. Some studies have shown the effects of Determining functional requirements
mobile-based applications on improving and enhancing In this phase, the functional requirements of the applica-
some of the measured outcomes in patients after stroke tion will be determined. Functional requirements will be
[11–14] while other studies showed the use of these obtained through the following four methods:
applications does not make a significant difference
compared to usual care. [15, 16]. In addition, the results • Selecting clinical guidelines
of a number of studies do not seem to be generalizable • Reviewing similar studies and applications
and might be at the risk of being biased, and accord- • Needs assessment of patients
ingly more studies are needed to yield more definitive • Needs assessment and localization of requirements
conclusions [7]. Therefore, in this study, we intend to based on expert opinion
first develop a mobile-based application and then solve
its usability problems by expert-based usability evalu- In this phase, based on the existing stroke self-care
ation. Finally, an interventional study will evaluate the guidelines, one of the clinical guidelines approved by
effects of this application on patients with stroke. The three neurologists will be selected at first and the func-
effect assessment of the application will be done by tional requirements of this guideline will be extracted by
focusing on the three main parts of the International researchers. Other functional requirements will also be
Classification of Functioning, Disability and Health extracted using a review study on applications done by
(ICF), namely the physical structure, individuals’ researchers and similar studies. In this regard, some sys-
tematic review studies have been conducted [7, 19–22]
Tadayon et al. BMC Medical Informatics and Decision Making (2022) 22:292 Page 3 of 12

Fig. 1 Method of software development

which will also be reviewed by researchers. Needs assess- sampling method. Finally, all these requirements will
ment of patients will be done as the most important be prepared in the format of Lawshe approach [23] and
stakeholder group of the application. For this purpose, a will be given to the experts. At this stage, a questionnaire
semi-structured interview will be used with patients who containing functional requirements and information
have previously suffered from stroke and partial paralysis content of the application will be given to neurologists,
and have now partially recovered. Due to the specific con- occupational therapists and physiotherapists for the pur-
ditions of the patients, the interview will be conducted in pose of localization. Delphi technique [24] will be used
a maximum of 20 min, but the number of sessions can in this step. Moreover, for needs analysis, 15–21 neurolo-
be increased to two or more sessions in order to assess gists, physiotherapists and occupational therapists who
patients’ needs. Sample interview questions are stated are faculty members of the country’s medical universities
in Table 1. These patients are required to have at least a and have at least three years of professional experience
diploma and be able to work with a smartphone. Patient will be consulted. At this stage, for each requirement, the
and caregiver interviews will continue until data satura- necessity, appropriateness, clarity and relevance will be
tion is reached and no new data should be produced in evaluated and in terms of necessity (CVR: Content Valid-
the interview. Samples will be selected by convenience ity Ratio), three levels (essential and useful, useful but
Tadayon et al. BMC Medical Informatics and Decision Making (2022) 22:292 Page 4 of 12

Table 1 Example of questions for patient interviews

No Question

Q1 During your illness, did you have any problems in doing activities of daily living (such as eating, going to the toilet, dressing, etc.)? Explain your
problems
Q2 Did you suffer from complications caused by the disease such as bedsores, urinary and fecal incontinence, shoulder pain, falls, depression and
other complications? Explain them and explain how you managed to improve them
Q3 Were you prescribed physiotherapy sessions? What exercises did you do during the physiotherapy treatment?
Q4 Did you have problems walking and maintaining your balance? Explain your problems
Q5 During your illness, did you feel the need to communicate with your doctor by phone? For what cases did you feel this need?
Q6 During your illness, did you feel the need for training to do some work? What training was needed more?
Q7 Did you need special training regarding prescribed drugs? (Knowing the side effects of drugs, changing the dosage of drugs, the duration of
continuing to take the drug, or stopping the use of drugs, changing the type of drugs). Explain
The interview questions will not be limited to these questions and the interview will continue in depth until the patient’s needs are acquired

unnecessary, non-useful) and in terms of appropriate- and evaluate the extent to which functional requirements
ness, clarity and relevance (CVI: Content Validity Index) and goals are met by this prototype. These experts will
four levels (from very high with a score of four to very include two neurologists, two physiotherapists and two
low with a score of one) will be defined. Questions with occupational therapists with at least three years of spe-
a CVR score of higher than the base number (0.62 for ten cialized work experience in the field of treatment and
individuals) based on Lawshe table will be approved and rehabilitation of patients with stroke.
those with a CVR score of less than that will be removed.
According to CVI, questions that have scores of higher Development of high‑fidelity interface
than 0.79 will be approved and those with scores between At this phase, based on the final version of the prototype
0.7 and 0.79 will be re-reviewed, corrected and returned obtained from the previous phase, the high-fidelity proto-
to the experts and finally those with scores less than 0.7 type will be developed by JAVA programming language.
will be rejected. This step will be repeated until the final A web server will also be developed using [Link] Core.
validity of the questionnaire content is confirmed. The In order to evaluate the usability of the prototype, Cog-
approved questionnaire will be provided to the experts nitive Walkthrough (CW) method will be used based on
in the next step and the experts’ answers to the com- the method proposed by Polson and Lewis [25]. By iden-
ponents of the questionnaire will be scored from 1 to 5 tifying and introducing tasks and actions and expressing
(very low = 1, low = 2, medium = 3, high = 4 and very them step by step, this method will enable those evalua-
high = 5) and then the average score of each item will be tors who have limited background knowledge about the
calculated. Minimum score for accepting each compo- system to identify usability problems properly [26]. For
nent will be considered as 3.75. If the score obtained for this purpose, a certain number of scenarios that repre-
each component is between 2.5 to 3.74, that component sent the most important and frequent application func-
will be modified and reviewed again. Components with a tions will be identified in harmony with the opinion of
score of less than 2.5 will also be removed from the appli- three neurologists. For each scenario, the main objec-
cation content. tive, sub-objectives, sequence of steps to do the tasks
and system responses will be prepared and approved
Development of low‑fidelity interface by the researchers. Then, the program will be provided
In this phase, based on the feedback and opinions to the evaluators. Five individuals will be chosen to do
received from experts in the previous step, first the items the evaluation through non-probability quota sampling.
and how the application works as a conceptual model Evaluators are required to have at least a master’s degree
will be designed and then the low-fidelity user inter- in health information technology/management or medi-
face (how to display the content of the application and cal informatics and have 2 years of professional experi-
the relationship between humans and smartphones) on ence in evaluating health information systems. They will
android platform will be developed using the appropriate independently perform the sequence of steps for each
programming language. Then, a primary prototype will scenario through the program’s user interface. Each eval-
be created and its validity will be evaluated. After imple- uator will put themselves in the position of the patient
menting functional requirements on the prototype for and observe the program from the patient’s point of view;
checking validity, six experts will review the application in case of any problems in performing the task steps, it
Tadayon et al. BMC Medical Informatics and Decision Making (2022) 22:292 Page 5 of 12

will be expressed by evaluators. This will happen at the will be performed by researchers. For this purpose, one
presence of the researcher as an observer who will write researcher will put him/herself in the position of the
the following items in data collection forms: evaluator’s patient and another researcher in the position of the phy-
comments, questions and uncertainties, an explanation sician. Feedback on probable defects of the application
of the usability problem identified by the evaluator, loca- will be given to application designers.
tion of the problem in the system and the time to perform
each scenario. At the end of each evaluation process, Implementation and evaluation of application in the live
each evaluator will review the list of the related prob- environment (clinical trial)
lems and suggest any solutions to solve potential issues. Study design and setting
Then, in a meeting, separate lists of evaluators will be At this stage, an interventional study will be conducted
compared and all of the identified problems will be put through patient blinding by an assessor physician and
on the list of main problems. Next, any duplicate prob- analyst to evaluate the effects of the application on patient
lems will be eliminated and the evaluators will be asked self-care. The designed application will be installed on
to assess the severity of the problems independently. This patients’ smartphones and the necessary training to use
rating will be based on three criteria including frequency it will be given to the patients and their caregivers. This
of the problem, impact of the problem and continuity application will support Android 5 and above. The study
of the problem. Scoring for each problem and criterion population will include patients referring to one of the
will be done in 5 degrees ranging from 0 (no problem) general hospitals in Kashan where sampling can be done
to 4 (severe problem). Then, the average of the identified in a convenient way. Patients with hemiplegia or hemipa-
problems will be calculated and relevant problems will be resis caused by a recent stroke will be chosen for this pur-
listed in order of intensity followed by feedback given to pose. Either the patient or his/her patient caregiver must
application designers. Also, in order to confirm usability have an Android-based smartphone and be able to work
of the application by users, the System Usability Scale with it. At least 72 h must have passed since the stroke
(SUS) questionnaire will be used and will be distributed (The acute phase of the disease must have passed) and
among 30 users who have previously had a stroke and patients must have adequate consciousness and hearing
have been working with the application for a week. This and be willing to participate in the study. Exclusion crite-
questionnaire will include 10 items (SUS01 to SUS10) ria will include:
with 5-point Likert scale and SUS score of 70 and above
will be considered acceptable [27]. SUS scores will be cal- • Patients who have some levels of consciousness dis-
culated as follows: order
SUS Score = 2.5 (20 + SUM (SUS01, SUS03, SUS05, • Patients with cognitive disorders such as dementia or
SUS07, SUS09) − SUM (SUS02, SUS04, SUS06, SUS08, memory impairment
SUS10)). According to this formula, SUS01 means item • Patients with global aphasia
number one in the questionnaire, and the list will con-
tinue. The validity and reliability of this questionnaire The formula “n = [(Z1−α/2 + ­Z1−β)2 * (σ12 + σ22)]/(x1 − x
have been confirmed in previous studies and its average 2
2) ” with the reliability of 95% and the test power of 90%
Cronbach’s alpha coefficient was estimated to be 0.91 based on the mean and standard deviation of baseline
[28]. NIHSS obtained in the same study [29] ­(Z1−α/2 = 1.96,
The results of users’ comments will also be given to the ­Z1−β = 1.282, σ1, σ2 = 8, x1 = 5, x2 = 12) was calculated as
designers. This step will be repeated until the application 27 patients, which increased to 30 patients according to
is approved by evaluators. The output of this phase will the available facilities which, with a 10% sample dropout,
be the final version of the application, which will be ready will increase to 33 individuals. Accordingly, two groups
to be implemented in a live environment. Support ser- each including 33 patients (intervention and control)
vices including bug fixation, content changes and other with stroke (66 patients in total) who meet the inclusion
application updates will be presented by system support criteria will be selected.
staff/admin.
Randomization
Application testing Randomization will be done by block method (Permuted
At this stage, the unit test of the final application will be Block Randomization) in a way that first all foursome
performed by researchers and different modules of the blocks which include two codes A and B will be prepared
application will be tested separately to confirm correct (6 blocks) and then, using a table with random numbers,
performance, which can help to eliminate any poten- random blocks will be selected by placement (15 blocks).
tial defects. In the next step, application integrity test These blocks will contain up to 60 codes including A
Tadayon et al. BMC Medical Informatics and Decision Making (2022) 22:292 Page 6 of 12

and B, each of which will be randomly assigned to either by creating valid accounts. Account creation by patients
the control or the intervention group. This table will be and physicians will be done by the system admin and
generated by MS Excel 2019 and function of RANDBE- demographic information will be recorded for them;
TWEEN (1,6). however, the usernames defined for users cannot be
changed by them. The application can record the number
Blinding of times and hours of application use by the user. In order
For the purpose of blinding, an application will be to learn how to use the application, users can contact one
installed on the smartphones of patients of both inter- of the research team members. A member of the research
vention and control groups. The program installed for team will also make weekly phone calls to make sure
patients in the control group will only contain online patients know how to use the application. Intervention
questionnaires that patients need to complete and submit for patients in the control group will include usual medi-
at specified intervals. Online questionnaires will include cal care based on the opinion of the responsible neu-
a number of questions used to measure the target vari- rologist (This can include physiotherapy or occupational
ables. However, the program installed on the phones of therapy). An application will be installed on the smart-
participants in the intervention group will include all the phones of these individuals which lacks the main capa-
capabilities and requirements of the self-care program bilities of the application and only contains electronic
designed in the design phase. Patients will not be famil- questionnaires. Installation of this application will be
iar with the nature and content of the installed program done only for blinding purposes. Intervention duration
on the opposite group’s phones. During program instal- and the time of measuring the outcomes will be the same
lation, someone other than the assessor physician will for both groups. Figure 2 shows the flowchart of proto-
install the program for patients or their caregivers. Fur- col for interventional trial. Re-stroke will be recorded in
thermore, during the assessment process, the same per- both groups and finally it will be considered as one of the
son will record the results of the physician evaluation and complications of stroke in both groups. Nevertheless, an
the scores related to each patient. Therefore, the asses- individual with re-stroke during the intervention due to
sor physician will not know which group a given patient entering the acute phase of the disease will be excluded
belongs to. Numeric codes for intervention and control from the study and replaced by another individual. To
groups will also be used for analysis, and the letters A and replace the new individual, the researcher will return
B will be used for the control and intervention groups to the hospital and replace another person who meets
when information is sent to the analyst. the study inclusion criteria (In case of excessive sample
fall). The research hypothesis is that using the proposed
Intervention intervention along with usual care can improve stroke
Intervention for patients in the intervention group (in outcomes. Therefore, this study can be considered as a
addition to usual care) will include an Android-based superiority trial. Routine rehabilitation interventions
application that has all the functional requirements (such as electrotherapy) cannot be eliminated at this
approved by the experts in the analysis and software time. Therefore, no hypothesis can be defined for this
design phases. This application will contain audio, video, intervention alone.
textual files and games to improve lower and upper limb
function and activities of daily living, prevent and reduce Data collection
depression, reduce and manage pain and other possible The required data will be collected using valid and reli-
complications of stroke, medication reminders and what- able questionnaires that are introduced as follows. Data
ever playing a role in improving patient outcomes, and will be collected in three stages: prior to intervention
will be designed according to experts’ opinion. Patients (before the intervention and at the time of discharge),
will be advised to use the application 5 days a week and two months after the intervention and three months
for a period of 1 h each day. The duration of the interven- after the intervention (in the doctor’s office or in the
tion will be 8 weeks (40 sessions in total). A systematic hospital outpatient clinic). Data from National Insti-
review study [21] showed that the duration of interven- tute of Health Stroke Scale (NIHSS) and Barthel Index
tion to improve physical activities using mobile phones (BI) questionnaires and stroke complication check-
was between 4 and 6 weeks, which could be extended to list will be filled out by the attending neurologist and
10 weeks for greater effectiveness. According to the con- other questionnaires will be filled out by patients as
ditions in the country and the opinion of experts and fol- self-report. Completion of questionnaires by patients
low-up protocols of patients, intervention for more than will be done electronically and sent online through the
8 weeks was not recommended due to the possibility of application. Therefore, this survey will be considered
excessive sample fall. Patients will access the application as a “closed survey” since only registered users with a
Tadayon et al. BMC Medical Informatics and Decision Making (2022) 22:292 Page 7 of 12

Fig. 2 Protocol for interventional trial

valid account can access the questionnaires and sub- defined as mandatory in electronic questionnaires and
mit them. Application features will be inactive until patients will be warned to answer all questions before
patients, complete questionnaire items. After com- sending the questionnaire.
pletion, application features will be activated and the All online questionnaires will exactly be designed the
questionnaire will be deactivated to prevent response same as paper questionnaires in terms of appearance,
duplications. The questionnaires will be reactivated two content and sequence of questions. That is, all the ques-
months and three months later. In order to ensure that tions will be placed consecutively and not on separate
no data will be missing, all fields and questions will be pages. Therefore, it can be said that the validity and
Tadayon et al. BMC Medical Informatics and Decision Making (2022) 22:292 Page 8 of 12

reliability reported for the paper version of question- The validity and reliability of the Persian version of this
naire will also apply to the electronic version. tool were confirmed in a study conducted by Tagharrobi
It is expected that the use of this application can et al. [33] The validity of the questionnaire was confirmed
improve the measured variables in the intervention using concurrent validity, comparison of known groups
group compared to the control group. Specifically, the and exploratory factor analysis and the reliability was
research hypotheses are that patients in the interven- confirmed using Cronbach’s alpha. The Cronbach’s alpha
tion group have significant differences with those in the coefficient of this instrument was reported as 0.99.
control group in terms of indicators of physical activity,
depression, quality of life, medication adherence, satis- Quality of life To assess the quality of life and the level
faction with treatment, and the number of complications. of social participation (covering the social participation
section of the ICF), the EQ-5D-3L (EuroQol group-5
Stroke severity and motor function The (NIHSS) ques- Dimentions-3 Level) questionnaire including 5 questions
tionnaire will be used to measure stroke severity and on a 3-point Likert scale will be used. The final score of
motor function of upper and lower limbs. Two items (out the questionnaire will be between 0 and 10. The validity
of 11 items) of this questionnaire will be related to motor and reliability of the Persian version were confirmed in a
function of limbs [30]. The data obtained from this ques- study done by Dastourani et al. [34] The construct validity
tionnaire will cover the section of body structure related and the differential validity were confirmed by testing the
to ICF. This questionnaire will have 11 items, each of predetermined hypotheses and by the method of known
which with 5 options and scores from 0 to 4 (a score of 0 groups, respectively. Cronbach’s alpha coefficient of this
indicates normal performance and a score of 4 indicates a questionnaire was reported as 0.89.
severe defect in performance). Due to the special type of
scoring, scores will eventually be obtained between 0 and Depression To assess the depression (covering the body
42, which will be divided as follows: structure section of ICF), the BDI-II (Beck Depression
Inventory-II) questionnaire will be used, which includes
0: No stroke symptoms 21 groups of sentences with a value scale of 0 to 3 express-
1–4: Mild stroke ing the patient’s feelings during the previous 2 weeks.
5–15: Medium stroke The scores of this questionnaire are between 0 and 63.
16–20: Moderate to severe stroke The validity and reliability of the Persian version of this
21–42: Severe stroke questionnaire were confirmed in a study done by Hamidi
et al. [35] The validity of the questionnaire was confirmed
The validity of this questionnaire was confirmed using descriptive and confirmatory factor analysis as well
using clinical predictor validity and its reliability was as convergent validity and its Cronbach’s alpha was 0.93.
approved with Cronbach’s alpha of 0.95 in Hinkle’s study
[31]. It should be noted that, in the present study, the Medication adherence The MMAS-8 (Morisky Medi-
original version of this questionnaire will be used by a cation Adherence Scale-8) questionnaire will be used to
neurologist. assess patients’ medication adherence. This questionnaire
consists of 8 questions, of which items 1 to 7 are yes/
Activities of daily living The Barthel Index (BI) question- no questions, and item 8 has a 5-point Likert scale. For
naire will be used to measure the activities of daily living items 1 to 7, for each no answer, a score of 1 and for each
(covering the activities section of ICF). This questionnaire yes answer, a score of 0 will be recorded. For question 8,
includes 10 key activities of daily living including: feed- scores from 0 to 4 (never, rarely, sometimes, often, always)
ing, bathing, grooming, dressing, bowels, bladder, toilet will be considered. The final score will be between 0 and 8,
use, transfers (bed to chair and back), mobility (on level with 8 indicating high adherence, 6 and 7 indicating mod-
surfaces) and stairs. In each item, scores are: 0 (depend- erate adherence, and less than 6 indicating low adherence.
ent), 5 (need for major help), 10 (need for minor help) and The validity and reliability of the Persian version of this
15 (independent). Finally, the ranking of people is done as questionnaire were confirmed in a study conducted by
follows: Ghanei Gheshlagh et al. [36] The validity was confirmed
using the concurrent criterion validity method and reli-
80–100: independent. ability. Cronbach’s alpha coefficient was reported as 0.72
60–79: slightly dependent. in this study.
40–59: relatively dependent.
20–39: very dependent Patient satisfaction The PSQ (Patient Satisfaction Ques-
Less than 20: completely dependent [32]. tionnaire) will be used to measure patient satisfaction
Tadayon et al. BMC Medical Informatics and Decision Making (2022) 22:292 Page 9 of 12

with the treatment. This questionnaire includes 11 items Pearson or Spearman correlation coefficient (accord-
with a 5-point Likert scale (from 0 for very poor to 4 for ing to the type of variable distribution) will be used to
excellent). The total score is a number between 0 and 44. determine the relationship between the usage duration
The scores of 0–10 mean poor satisfaction, scores 11–21 of the program and the score of the measured variables.
mean good satisfaction, scores 22–32 mean very good After categorizing the time of application usage, one-
satisfaction and scores 33–44 mean excellent satisfaction. way ANOVA or Kruskal–Wallis’s test (depending on the
The validity and reliability of the Persian version of this type of variable distribution) will be used to determine
questionnaire were confirmed in a study done by Yousefi the relationship between the measured variables and the
Golafshani et al. [37] The face validity and content valid- time of application usage. Chi-square test will be used to
ity were confirmed using the opinions of 10 experts in determine the relationship between the type of complica-
the field of medical education and Cronbach’s alpha was tions in both groups. Also, to determine the relationship
reported as 0.98. between the scores of the measured variables before and
after the intervention, a paired t-test will be used in each
Complications To assess the frequency and type of com- group separately. Hypothesis H0 will indicate the absence
plications in patients, a stroke complication checklist will of correlation and Hypothesis H1 will indicate the exist-
be used which includes a total of 19 complications, eight ence of correlation between the measured variables.
of which are based on the most common stroke complica-
tions from the perspective of the American Heart Associ- Discussion
ation (AHA) and the American Stroke Association (ASA) Various protocols have been designed to evaluate the
[38] and 11 of which are based on the most common com- impact of mobile applications and trainings on the out-
plications reported in related studies [39–42]. This check- comes of patients with stroke [44–47]. However, these
list will be prepared by the researchers and the face and studies differ in terms of sample size, number of vari-
content validity of this checklist will be confirmed by 3 ables and outcomes to be measured, duration of inter-
neurologists. vention and protocol design. In Iran, a study in which
first an application is designed using expert and patient
Data analysis needs assessments according to a standard guideline
Data analysis will be performed using IBM SPSS 22 and then the impact of designed application on patients
[43]. The data will be entered anonymously using codes with stroke is evaluated has not been done yet. In other
and numbers, which can be decoded only by one of the foreign studies, less attention has been paid to different
researchers (except the assessor or the analyst). The data aspects of ICF. However, in the present study, we will
will be stored in this software application and supported try to evaluate the outcomes based on valid and reliable
by a backup on another system kept in another place. The questionnaires that are related to different sections of
data will be first presented in the form of descriptive sta- ICF.
tistics and frequency distribution tables. The normality of In addition to providing educational materials via text
the data will be checked using the Kolmogorov–Smirnov and image, the application will provide appropriate exer-
test. Depending on the type of data distribution, the cises using educational video clips. It will also contain
mean or median of the data will be used as a criterion. items such as reminders and warnings to take medica-
In case of normal distribution of data, the mean will be tions and doctor’s appointments, the possibility of com-
used and in case of abnormal distribution (non-para- municating with the therapist via chats, voice calls or
metric), the median will be used for statistical calcula- video calls, the possibility of weekly goal setting, and
tions. In order to determine the relationship between the writing notes related to the rate of goal achievement. It
scores of patients’ activities of daily living, quality of life, is expected that the use of this application will potentially
depression, medication adherence and patient satisfac- improve and enhance the motor function of the upper
tion with patients’ group type (control or intervention), and lower limbs, balance and walking, social participa-
an independent t-test will be used. If there is a significant tion and self-efficacy in the intervention group more than
difference between the intervention group and the con- those of the control group. In similar studies [48–50], the
trol group, the effect of the intervention will be speci- positive effects of mobile applications on improving the
fied. Repeated measures analysis of variance (ANOVA) motor function of limbs after stroke have been shown.
will also be used to analyze multivariate and control the However, some other studies [51, 52] have reported the
effects of confounding variables on dependent variables. use of this type of intervention on the motor function of
Confounding variables will include: patient age, sex and the limbs without significantly improved effects. The rea-
educational level, which can affect the final results. In sons for this difference can be related to various factors
all tests, a significance level of 0.05 will be considered. such as the context of the society under study, the mobile
Tadayon et al. BMC Medical Informatics and Decision Making (2022) 22:292 Page 10 of 12

application used and its capabilities, the duration of the needs assessment of all stakeholders. This can be a great
intervention and the level of patient cooperation to use advantage over studies that use an off-the-shelf applica-
the application. tion because it will be designed and adapted to the needs
All instructions and exercises in the application will of the population under study.
be approved by the experts to be considered safe for The ability to generalize the results of the study to simi-
patients to minimize the possibility of causing harm. To lar populations should be somewhat cautious. Although
eliminate the risk of possible harm to patients during the sample at of this study is based on the formula and
exercise, they will be advised to start the training with an data obtained from previous studies, it is nevertheless a
easy level and to make sure that the exercises are done in relatively small sample. Therefore, the generalizability of
the presence of a caregiver, and that the way to receive the results of this study needs to be done with caution.
support from a caregiver is fully taught in the applica-
tion through videos. All of the ethical considerations in
clinical trials (including Helsinki ethical codes) will be Trial status
considered by researchers. If medical complications arise Expected recruitment start date is April 2022 (after the
during the study; patients will be treated for free by the manuscript submission date) and the recruitment will
responsible physician. Compensation in this regard will be completed approximately in September 2022. Possi-
be done according to the laws of the Medical System ble changes related to the protocol will be transferred to
Organization. the Iranian Registry of Clinical Trials (IRCT) System and
For auditing the trial, after registering each sample, a the necessary changes will be made and informed on that
researcher will monitor the patient registration process website.
and assign them to either the control or intervention
group using the admin-side application. The comple- Abbreviations
tion of questionnaires by patients will also be monitored AHA: American Hospital Association; ANOVA: Analysis of Variance; ASA: Ameri-
can Stroke Association; AU: Attribute of Usability; BDI: Beck Depression Index;
by this person. If the questionnaires are not filled out, BI: Barthel Index; CVI: Content Validity Index; CVR: Content Validity Ratio; CW:
patients will be reminded though a phone call. Filling out Cognitive Walkthrough; EQ-5D-3L: EuroQol group-5 Dimensions-3 Levels; ICF:
the questionnaires will be audited two and three months International Classification of Functioning, disability and health; MMAS-8:
Morisky Medication Adherence Scale-8 items; NIHSS: National Institute of
after patient registration and the necessary actions will be Health Stroke Scale.
done in case of possible delays. These actions will include
sending reminders through the application, sending mes- Acknowledgements
Special thanks to Health Information Management Research Center and Vice
sages and making phone calls. Chancellor for Research and Technology of Kashan University of Medical Sci-
The most important limitation of this study is the pos- ences for their supports.
sibility of lack of cooperation of some patients to partici-
Author contributions
pate in the study. Researchers will understand the specific HT made substantial contributions to the conception, drafting and design.
conditions of patients with stroke and will fully explain SAM is the scientific director of the clinical trial and is responsible for assess-
the purposes of the study to them, but in any case, if ment of patients. HT, MF, EN are responsible for software development and
HA is responsible for recording and analyzing data. All authors have read and
patients, despite being informed about the goals and approved the final manuscript.
efforts of researchers to obtain their satisfaction, seem
to be unwilling to participate in the study, according to Funding
This protocol is done for partial fulfillment of the requirements for the degree
the principle of informed and free consent, they will be of Ph.D. dissertation in the field of health information management, which has
excluded from the study at any time during the research. been approved by Health Information Management Research Center and the
Another limitation is the lack of qualified patients at the Vice Chancellor for Research of Kashan University of Medical Sciences with the
research number 99128. This internal funder will be provided part or all of the
study site, which will probably make the sampling longer, costs for developing application according to the future contract. The authors
but will not harm the results of the study. However, larger do not receive any grants from nonprofit organizations or funding agencies
trials with larger samples in centers with more patients either in public or commercial sectors.
are recommended. One of the operational problems in Availability of data and materials
studies of this type is the possibility of patients not being The datasets used and/or analyzed during the current study are available from
able to work with smartphones. If the patient is not able the corresponding author on reasonable request.
to work with a smartphone, his/her caregiver will be con-
sulted. Of course, this person needs to be someone such Declarations
as a patient’s wife/husband or child who is always avail- Ethics approval and consent to participate
able to the patient. This study was approved in Kashan University of Medical Sciences with
It can be said that the most important strength of this the ethics code of [Link].1399.055 and its protocol was
registered and approved in the Iranian Registration of Clinical Trial (IRCT) with
trial is the development of an application based on the the code of IRCT20201015049037N1. In all stages of conducting research on
Tadayon et al. BMC Medical Informatics and Decision Making (2022) 22:292 Page 11 of 12

patients, the neurologist will continuously monitor the method of conducting stroke supported by information and communication technology—a
the study. All usual care, which is performed for patients in the control group, feasibility study. BMC Neurol. 2020;20(1):387.
will also be performed for patients in the intervention group, based on the 11. Shin DC, Song CH. Smartphone-based visual feedback trunk control
opinion of neurologists. Implicit and verbal informed consent will be obtained training using a gyroscope and mirroring technology for stroke
from all patients by one of the researchers and all patients will have the right patients: single-blinded, randomized clinical trial of efficacy and feasi-
for informed and free consent to participate in the study. There will be no bility. Am J Phys Med Rehabil. 2016;95(5):319–29.
biological specimens in this study. Patients’ identities will not be disclosed and 12. Kim DY, Kwon H, Nam KW, Lee Y, Kwon HM, Chung YS. Remote Man-
data will be provided anonymously to others, if necessary. Written informed agement of poststroke patients with a smartphone-based manage-
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ties in patients. If a patient decides to stop the intervention in the middle of interventional study. J Med Internet Res. 2020;22(2): e15377.
the research, the researchers will consider themselves obliged to respect this 13. Torrisi M, Maresca G, De Cola MC, Cannavò A, Sciarrone F, Silvestri G,
request and without changing the treatment, they will exclude the patient Bramanti A, De Luca R, Calabrò RS. Using telerehabilitation to improve
from the study and replace this individual with another patient with similar cognitive function in post-stroke survivors: is this the time for the
conditions. Doing this research will not harm the environment or vulner- continuity of care? Int J Rehabil Res. 2019;42(4):344–51.
able groups. Researchers will be committed to the principle of privacy and 14. Grau-Pellicer M, Lalanza JF, Jovell-Fernández E, Capdevila L. Impact of
confidentiality and no identity information about patients will be disclosed in mHealth technology on adherence to healthy PA after stroke: a rand-
the results of the study. Researchers will be obliged to publish the results of omized study. Top Stroke Rehabil. 2020;27(5):354–68.
the research honestly, accurately and completely and to provide it to research 15. Kang Y-N, Shen H-N, Lin C-Y, Elwyn G, Huang S-C, Wu T-F, Hou W-H.
participants and other stakeholders. The method of conducting this study will Does a Mobile app improve patients’ knowledge of stroke risk factors
not contradict any social, cultural and religious values. Expected recruitment and health-related quality of life in patients with stroke? A randomized
start date is April 2022. Results of this study have not already been published controlled trial. BMC Med Inform Decis Mak. 2019;19(1):282.
or submitted to any journal. 16. Chen J, Jin W, Dong WS, Jin Y, Qiao FL, Zhou YF, Ren CC. Effects of
home-based telesupervising rehabilitation on physical function for
Consent for publication stroke survivors with hemiplegia: a randomized controlled trial. Am J
Not applicable. Phys Med Rehabil. 2017;96(3):152–60.
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Health Information Management Research Center, Kashan University of Medi- mer’s disease: a day center case study. Int J Med Informatics. 2019;131:
cal Sciences, Kashan, Iran. 2 Department of Health Information Management & 103972.
Technology, Kashan University of Medical Sciences, Kashan, Iran. 3 Department 19. Moral-Munoz JA, Zhang W, Cobo MJ, Herrera-Viedma E, Kaber DB.
of Biostatistics, Kashan University of Medical Sciences, Kashan, Iran. 4 Depart- Smartphone-based systems for physical rehabilitation applications: a
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Ravandi Blvd, Kashan, Iran. 20. Piran P, Thomas J, Kunnakkat S, Pandey A, Gilles N, Weingast S, Burton
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