Protocol summary
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Study aim
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ٍEvaluation of stroke self-management application effect on the patients
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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Changing the recruitment start date is expected for two reasons. Firstly, due to the delay in the design of the application, which is an intervention tool, and secondly, due to the temporary closure of the neurology department of the hospital due to the COVID-19 pandemic.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201015049037N1
Registration date:
2020-11-07, 1399/08/17
Registration timing:
prospective
Last update:
2021-11-02, 1400/08/11
Update count:
1
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Registration date
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2020-11-07, 1399/08/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-02-20, 1400/12/01
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Expected recruitment end date
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2022-07-23, 1401/05/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of Effectiveness of Mobile-based Self-management Application with Usual Care on Rehabilitation of Patients with Stroke
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Public title
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Effect of mobile-based self-management application on stroke outcomes
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-10-10, 1399/07/19
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Ethics committee reference number
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IR.KAUMS.NUHEPM.REC.1399.055
Health conditions studied
1
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Description of health condition studied
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Stroke
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ICD-10 code
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I63
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ICD-10 code description
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Cerebral infarction
Primary outcomes
1
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Description
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Stroke severity score in NIHSS
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Timepoint
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First, after 2 months, after 3 months
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Method of measurement
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NIHSS Completion by Neurologist
2
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Description
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Barthel daily activity score
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Timepoint
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First, after 2 months, after 3 months
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Method of measurement
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BI (Barthel Index) questionnaire completion by Neurologist
3
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Description
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Quality of life score in EQ-5D
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Timepoint
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First, after 2 months, after 3 months
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Method of measurement
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EQ-5D questionnaire completion by patients
4
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Description
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Beck-II depression score
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Timepoint
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First, after 2 months, after 3 months
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Method of measurement
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Beck II Depression questionnaire completion by patients
5
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Description
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PSQ treatment satisfaction score
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Timepoint
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First, after 2 months, after 3 months
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Method of measurement
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PSQ questionnaire completion by patients
6
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Description
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Morisky medication adherence score (MMAS-8)
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Timepoint
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First, after 2 months, after 3 months
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Method of measurement
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MMAS-8 questionnaire completion by patients
7
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Description
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Frequency of stroke complications
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Timepoint
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First, after 2 months, after 3 months
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Method of measurement
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Stroke complication checklist completion by Neurologist
Intervention groups
1
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Description
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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).
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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6 months after study publication
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To whom data/document is available
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Final results and protocol for all people and data file and statistical file on scientific centers request
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Under which criteria data/document could be used
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Only scientific centers can send request for access to data for academic analysis
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From where data/document is obtainable
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Kashan university of medical sciences, paramedical school, Hamidreza Tadayon or Hossein Akbari
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What processes are involved for a request to access data/document
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Request must be sent to school by post or sent to follow email:
tadayonh1@nums.ac.ir
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Comments
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