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IRCT20201015049037N1 IRCT 2020-11-07 Kashan University of Medical Sciences Effect of mobile-based self-management application on stroke outcomes Comparison of Effectiveness of Mobile-based Self-management Application with Usual Care on Rehabilitation of Patients with Stroke 2022-02-20 anticipated 60 Complete https://irct.ir/trial/51674 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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. N/A Stroke. Intervention 1: 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). Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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: 6 months after study publication To whom: Final results and protocol for all people and data file and statistical file on scientific centers request Conditions: Only scientific centers can send request for access to data for academic analysis Where to obtain: Kashan university of medical sciences, paramedical school, Hamidreza Tadayon or Hossein Akbari How to obtain: Request must be sent to school by post or sent to follow email: tadayonh1@nums.ac.ir Comments:
public Mehrdad Farzandipour
ًQotb-e Ravandi Blvd
Kashan Iran (Islamic Republic of) 8715973449 +98 31 5554 0021 farzandipour_m@kaums.ac.ir Kashan University of Medical Sciences scientific ُSeyed Ali Masoud
Qotb-e Ravandi Blvd
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5554 0026 masoud_a@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) 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 no limit no limit Both Disorders of consciousness level Cognitive disorders for example dementia or memory disturbance Patients with global aphasia I63 Cerebral infarction Rehabilitation Other 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). 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. Stroke severity score in NIHSS. Timepoint: First, after 2 months, after 3 months. Method of measurement: NIHSS Completion by Neurologist. Barthel daily activity score. Timepoint: First, after 2 months, after 3 months. Method of measurement: BI (Barthel Index) questionnaire completion by Neurologist. Quality of life score in EQ-5D. Timepoint: First, after 2 months, after 3 months. Method of measurement: EQ-5D questionnaire completion by patients. Beck-II depression score. Timepoint: First, after 2 months, after 3 months. Method of measurement: Beck II Depression questionnaire completion by patients. PSQ treatment satisfaction score. Timepoint: First, after 2 months, after 3 months. Method of measurement: PSQ questionnaire completion by patients. Morisky medication adherence score (MMAS-8). Timepoint: First, after 2 months, after 3 months. Method of measurement: MMAS-8 questionnaire completion by patients. Frequency of stroke complications. Timepoint: First, after 2 months, after 3 months. Method of measurement: Stroke complication checklist completion by Neurologist. Kashan University of Medical Sciences Approved 2020-10-10 Kashan University of Medical Sciences Qotb-e Ravandi Blvd Kashan Isfehan Iran (Islamic Republic of)