ٍEvaluation of stroke self-management application effect on the patients
Design
The clinical trial will have an intervention and a control group, with parallel groups, randomized; single blind (patient or caregiver and analyst) performing among 60 patients. For randomization, the permuted block randomization method with replacement will be used.
Settings and conduct
The study population was all patients with stroke referred to Shahid Beheshti Hospital in Kashan in whom at least 72 hours has passed since the stroke. The study will be single blind in which the participants, their caregivers as well as the analyst will be blind.
Participants/Inclusion and exclusion criteria
Patients with hemiparesis due to recent stroke are included in the study, and patients in the acute phase of the disease (first 72 hours after stroke) are not included in the study.
Intervention groups
Intervention group: Receiving a self-management application containing educational files and games (determined according to experts panel in the Delphi study phase) and performing the exercises in that for one hour in a day and 5 days in a week for two months totally (a total of 40 Session).
Control group: Patients receiving usual medical care and receiving application without self-management education capabilities. These patients receive only usual care based on the attending physician's opinion.
Main outcome variables
Stroke severity score; Ability to perform daily activities score; Quality of life score; Depression score; Medication adherence rate score; Treatment satisfaction score; Frequency of stroke complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201015049037N1
Registration date:2020-11-07, 1399/08/17
Registration timing:prospective
Last update:2020-11-07, 1399/08/17
Update count:1
Registration date
2020-11-07, 1399/08/17
Registrant information
Name
Hamidreza Tadayon
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4452 6568
Email address
tadayonh1@nums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effectiveness of Mobile-based Self-management Application with Usual Care on Rehabilitation of Patients with Stroke
Public title
Effect of mobile-based self-management application on stroke outcomes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hemiplegia or hemiparesis due to current stroke
having android-based mobile by patient or him/her caregiver
acute phase of stroke has been passed
appropriate consciousness and hearing
willingness to participation
Exclusion criteria:
Disorders of consciousness level
Cognitive disorders for example dementia or memory disturbance
Patients with global aphasia
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted Block Randomization will be used. First, all blocks of size 4 consisted of two codes A and two codes B, are prepared (6 blocks). Then, using a table of random numbers, random blocks are selected by replacement (15 blocks). These blocks form a sequence of 60 codes A and B, each of which is randomly assigned to one of the control or intervention groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
An interventional study is performed with patient and analyst blindness to evaluate the impact of the application on patients' self-care. Patients are blinded in such a way that an application is installed on the phone of both intervention and control patients. But the program that is installed for patients in the control group only contains online questionnaires that patients must complete and submit at specified intervals. Online questionnaires include some questionnaires used to measure the target variables and include BDI-II, EQ-5D-3L, MMAS-8 and PSQ questionnaires that were answered self-reportedly by patients in both groups and as posted online. But the program installed on the phones of patients in the intervention group has all the capabilities of intervention. But patients do not know the nature of the program installed on the phone of the opposite group. Numerical codes are also used for the analyst and intervention groups, and the letters A and B will be used for the control and intervention groups when we want to send information for analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan university of medical sciences
Street address
Qotb-e Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2020-10-10, 1399/07/19
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1399.055
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Stroke severity score in NIHSS
Timepoint
First, after 2 months, after 3 months
Method of measurement
NIHSS Completion by Neurologist
2
Description
Barthel daily activity score
Timepoint
First, after 2 months, after 3 months
Method of measurement
BI (Barthel Index) questionnaire completion by Neurologist
3
Description
Quality of life score in EQ-5D
Timepoint
First, after 2 months, after 3 months
Method of measurement
EQ-5D questionnaire completion by patients
4
Description
Beck-II depression score
Timepoint
First, after 2 months, after 3 months
Method of measurement
Beck II Depression questionnaire completion by patients
5
Description
PSQ treatment satisfaction score
Timepoint
First, after 2 months, after 3 months
Method of measurement
PSQ questionnaire completion by patients
6
Description
Morisky medication adherence score (MMAS-8)
Timepoint
First, after 2 months, after 3 months
Method of measurement
MMAS-8 questionnaire completion by patients
7
Description
Frequency of stroke complications
Timepoint
First, after 2 months, after 3 months
Method of measurement
Stroke complication checklist completion by Neurologist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: group receiving self-management application. The intervention includes an application containing instructional text, audio, and video files, and possibly games to improve upper and lower limbs function. Reminder programs for medications and reminders for visits will also be set up for patients. The functional requirements of the program are specified in detail in the design phase of the program. The number of sessions offered to patients will be 5 days in a week and every day for one hour and a total of 2 months (40 sessions in total).
Category
Rehabilitation
2
Description
Control group: Receiving medical usual care based on the opinion of the attending neurologist and receiving an application without educational files and only containing electronic questionnaires for blinding.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Mehrdad Farzandipour
Street address
Pezeshk Blvd
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0026
Email
farzandipour_m@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mehrdad Farzandipour
Street address
Qotb-e Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973449
Phone
+98 31 5554 0021
Email
farzandipour_m@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mehrdad Farzandipour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Information Management
Street address
ًQotb-e Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973449
Phone
+98 31 5554 0021
Email
farzandipour_m@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
ُSeyed Ali Masoud
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Qotb-e Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Email
masoud_a@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Tadayon
Position
Ph.D. Candidate
Latest degree
Master
Other areas of specialty/work
Health Information Management
Street address
Qotb-e Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973449
Phone
+98 31 5554 0021
Email
tadayonh1@nums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Participants' data file, statistical analysis and codes used in the analysis will be available in SPSS file format. Clinical study and protocol will be published by open paper.
When the data will become available and for how long
6 months after study publication
To whom data/document is available
Final results and protocol for all people and data file and statistical file on scientific centers request
Under which criteria data/document could be used
Only scientific centers can send request for access to data for academic analysis
From where data/document is obtainable
Kashan university of medical sciences, paramedical school, Hamidreza Tadayon or Hossein Akbari
What processes are involved for a request to access data/document
Request must be sent to school by post or sent to follow email:
tadayonh1@nums.ac.ir