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CTRI Number  CTRI/2022/06/042980 [Registered on: 02/06/2022] Trial Registered Prospectively
Last Modified On: 26/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Medication adherence and management of risk factors for secondary stroke prevention 
Scientific Title of Study   Medication adherence and management of risk factors for secondary prevention of stroke using smart phone- based application: A feasibility study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr P N Sylaja 
Designation  Professor and Head, Department of Neurology 
Affiliation  Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum 
Address  In-Charge, Comprehensive Stroke Care Program. Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum - 695 011, Kerala, India.

Thiruvananthapuram
KERALA
695011
India 
Phone  04712524482  
Fax    
Email  sylajapn@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr P N Sylaja 
Designation  Professor and Head, Department of Neurology 
Affiliation  Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum 
Address  In-Charge, Comprehensive Stroke Care Program. Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum - 695 011, Kerala, India.

Thiruvananthapuram
KERALA
695011
India 
Phone  04712524482  
Fax    
Email  sylajapn@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Veena Babu 
Designation  PhD Scholar, Department of Neurology 
Affiliation  Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum 
Address  Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum - 695 011, Kerala, India.

Thiruvananthapuram
KERALA
695011
India 
Phone  9605137399  
Fax    
Email  veena.bla@gmail.com  
 
Source of Monetary or Material Support  
World Stroke Organization. Rue Francois-Versonnex7 1207 Geneva, Switzerland. 
 
Primary Sponsor  
Name  World Stroke Organization 
Address  Rue Francois-Versonnex7 1207 Geneva, Switzerland. 
Type of Sponsor  Other [Organization] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr P N Sylaja  Sree Chitra Tirunal Institute for Medical Sciences and Technology  Room No:3109, Stroke Office, Comprehensive Stroke Care Program, Department of Neurology
Thiruvananthapuram
KERALA 		 9446566287

sylajapn@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sree Chitra Tirunal Institute for Medical Sciences and Technology  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I63||Cerebral infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Information advice regarding risk factor control and targets.  The subjects allocated in the control arm will receive routine information advice regarding risk factor control and its targets and medication adherence. The patients will be followed up for 6 months, including a direct visit with their treating neurologist in the 3rd and 6th months along with their risk factor values (blood pressure, blood sugar, and lipid profile). 
Intervention  Mobile-based app  The subjects allocated to the intervention arm will receive mobile-app-based intervention for improving their stroke medication adherence and control of risk factors for secondary prevention post-stroke. The app aims to improve medication adherence, control vascular risk factors, and provide health education and physician involvement. The participants in the intervention group are made to update their monthly risk factor values of blood pressure and blood sugar. Based on their values they will receive messages on their control status and a physician intervention is planned when required. The patients will be followed up for 6 months, including a direct visit with their treating neurologist in 3rd month and 6th month, and their risk factor values (blood pressure, blood sugar, and lipid profile). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Adult (>18 years) patients with onset of stroke within 1 month.
2.Severity :- mRs<5
3.Presence of one or more vascular risk factors such as hypertension, diabetes mellitus, smoking and dyslipidemia.
4.Patient/caregivers who could fully understand the use of an Android-based smartphone.
 
 
ExclusionCriteria 
Details  1.Patients with severe disability -modified Rankin Scale score>4
2.Patients who do not consent.
3.Severe cognitive impairment.
4.Stroke survivor without a primary caregiver. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Medication adherence is defined as consumption of at least more than 80% of their medications for the last two weeks based on the last prescription.

2. Control of vascular risk factors 		 Baseline, Three months and Six months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Vascularevents-TIA/Stroke/Cardiac events/Vascular deaths
2. Functional outcome-assessed by mRS
 		 Baseline, Three months and Six months 
 
Target Sample Size   Total Sample Size="192"
Sample Size from India="192" 
Final Enrollment numbers achieved (Total)= "204"
Final Enrollment numbers achieved (India)="204" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/06/2022 
Date of Study Completion (India) 09/03/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This study aims to develop a smart phone based personal monitoring app among stroke survivors to improve adherence to the medication, control of vascular risk factors, provide health education and physician involvement. Phase 1 of the study will be development of mobile app using Qualitative -Delphi method and phase 2 will be a randomized controlled trial designed to determine the feasibility of using this app in hospital setting for secondary stroke prevention. One hundred and ninety-two (n=192) adult patients with onset of stroke within 1 month will be randomized into intervention and control arm. The primary outcome will be assessed as medication adherence and control of vascular risk factors. The secondary outcome will be Vascular events namely TIA/Stroke/Cardiac events/Vascular deaths, functional outcome which will be assessed by mRS. The follow up will be done at the baseline, 3 month and 6 month. The data will be analyzed using appropriate statistical measures to determine efficacy of the mobile app in secondary prevention of stroke.

 
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