| CTRI Number |
CTRI/2024/04/066474 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Smartphone-based medication adherence and management of risk factors for secondary stroke prevention among stroke survivors |
|
Scientific Title of Study
|
A multicentric prospective trial on smartphone-based medication adherence and risk factor control for secondary prevention of stroke and decentralizing stroke care in Kerala. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
P N Sylaja |
| Designation |
Professor and Head, Department of Neurology |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology,. |
| Address |
Comprehensive Stroke Care Program, Room No:3109, Stroke Office, Department of Neurology
Medical College P.0, Thiruvananthapuram-11
Thiruvananthapuram
KERALA
695011
India |
| Phone |
04712524482 |
| Fax |
|
| Email |
sylajapn@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P N Sylaja |
| Designation |
Professor and Head, Department of Neurology |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology,. |
| Address |
Comprehensive Stroke Care Program, Room No:3109, Stroke Office, Department of Neurology
Medical College P.0, Thiruvananthapuram-11
Thiruvananthapuram
KERALA
695011
India |
| Phone |
04712524482 |
| Fax |
|
| Email |
sylajapn@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Veena Babu |
| Designation |
PhD Scholar,Department of Neurology |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology. |
| Address |
Comprehensive Stroke Care Program, Room No:3109, Stroke Office, Department of Neurology
Medical College P.0, Thiruvananthapuram-11
Thiruvananthapuram
KERALA
695011
India |
| Phone |
04712524343 |
| 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-Versonnex 7,
Geneva 1207,
Switzerland.
E-mail: admin@world-stroke.org |
| Type of Sponsor |
Other [Organization] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| 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
Thiruvananthapuram
KERALA |
04712524482
sylajapn@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, Sree Chitra Tirunal Institute for Medical Sciences and Technology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mobile-based app |
All the subjects enrolled in the study will receive mobile-app-based intervention for improving their stroke medication adherence and control of risk factors for secondary stroke prevention. The app aims to improve medication adherence, control of vascular risk factors, and provide health education and physician involvement based on their risk factor status. The participants in the intervention group will be educated to update their medication intake, monthly values of blood pressure, blood sugar and serum cholesterol. Based on their values they will receive SMS messages on their medication adherence, risk-factor control status and a physician intervention is planned when required which will be communicated through the SMSs sent from the app. The patients will be followed up for 6 months, including a direct visit with their treating neurologist at 3rd and 6th month. Participants will be assessed for the usability of the app as well as willingness for down referrals to lower centres. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients with onset of stroke within 3 years.
2. Severity:- (Modified Rankin Scale)mRS less than and equal to 4.
3. Presence of one or more vascular risk factors such as hypertension, diabetes mellitus, smoking and dyslipidemia.
4. Patients who could understand the use of an Android-based smartphone.
|
|
| ExclusionCriteria |
| Details |
1. Patients with severe disability -modified Rankin Scale score greater than 4
2. Patients who do not consent.
3. Severe cognitive impairment.
4. Stroke survivors without a primary caregiver in patients with mRS-3 and 4.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome:
1. Medication adherence
Co-Primary outcome
1. Changes in the lifestyle and behavioral factors.
2. Control of vascular risk factors measured at third and sixth months.
3. Barriers and facilitators for risk factor monitoring in the secondary prevention of stroke
|
Baseline, Three months, Six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Proportion of participants willing for down referral to primary health center (PHCs) from tertiary care center.
2. Vascular events‑Myocardial infarction (MI)/Transient ischemic attack (TIA)/stroke/cardiac events/vascular deaths at third and sixth months.
3. Functional outcome assessed by mRS at third and sixth months.
|
Baseline, three months, six months |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
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
validate the use of a smartphone-based app for medication adherence, vascular
risk factor control, lifestyle and behavioral modification among stroke
survivors in Kerala and also to evaluate the usability of this smartphone-based app by the participants for secondary prevention of stroke. The study
will also assess the barriers and facilitators for medication adherence and
vascular risk factor monitoring for secondary prevention of stroke among stroke
survivors,determine the utilization of primary
health centres (PHCs) / NCD clinic for secondary prevention of stroke among
stroke survivors.
Two hundred and eighty(n=280) adult patients with onset of stroke within 1 year of stroke and
with severity of mRs < 4 will be enrolled from 9 stroke units of the
state of Kerala. The primary outcome will
be assessed as medication adherence. The Co-Primary outcome will be change in
lifestyle and behavioral factors ,control of
vascular risk factors and barriers and facilitators for risk factor monitoring
in secondary stroke prevention. The secondary
outcome will be proportion of participants
willing for down referral to primary health centres (PHCs) from tertiary care
centre,Vascular events namely
TIA/Stroke/Cardiac events/Vascular deaths
and 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. |