Medication adherence and management of risk factors for secondary stroke prevention
| ISRCTN | ISRCTN31718066 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31718066 |
| Secondary identifying numbers | V2 dt 10 January 2022 |
- Submission date
- 25/01/2023
- Registration date
- 09/02/2023
- Last edited
- 12/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
The burden of stroke is increasing in India. One out of every four strokes is recurrent. The leading risk factors for stroke are high blood pressure, diabetes, high body mass index, smoking and air pollution. Secondary stroke prevention is important in preventing stroke recurrence. Adherence to medication is a key issue in treatment success and control of risk factors. Adherence to secondary preventive medications after a stroke is known to be suboptimal, especially in low- and middle-income countries. Evidence shows that establishing daily routines, periodic reminders, financial support to buy medicines and patient education can enhance medication adherence to prevent future strokes. The role of mobile phones in promoting adherence to medication and secondary prevention of stroke has not been extensively explored adequately. India is particularly suited for a mobile phone-based intervention given the widespread geographical connectivity, cheaper costs and the growing popularity of mobile phones. So this study aims:
1. To develop a smartphone-based app for medication adherence and secondary prevention of stroke among first-ever stroke survivors.
2. To test the feasibility of using a smartphone-based app to assess medication adherence, risk factor control and lifestyle modification for secondary stroke prevention
2. To compare the event rate between conventional and smartphone app-based follow-up.
Who can participate?
Patients aged over 18 years) who have had a stroke within 1 month and have one or more risk factors such as high blood pressure, diabetes, smoking and dyslipidemia (abnormal amount of fats in the blood)
What does the study involve?
Participants allocated to the intervention group will receive a 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 to their treating neurologist in the 3rd and 6th months, and their risk factor values are measured (blood pressure, blood sugar, and lipid profile).
What are the possible benefits and risks of participating?
The participants may benefit by adhering to their stroke medication and monthly monitoring of risk factors and having better control of risk factors by timely consultation with a local physician for medication alteration and lifestyle modification. As such there are no potential risks to the participants.
Where is the study run from?
Sree Chitra Tirunal Institute of Medical Sciences & Technology (India)
When is the study starting and how long is it expected to run for?
November 2021 to February 2023
Who is funding the study?
World Stroke Organization (Switzerland)
Who is the main contact?
Dr P N Sylaja, sylajapn@hotmail.com
Contact information
Principal Investigator
Department of Neurology
Sree Chitra Tirunal Institute of Medical Sciences & Technology
Thiruvananthapuram
695011
India
 ORCID ID |
0000-0003-4896-8275 |
|---|---|
| Phone | +91 (0)4712524482 |
| sylajapn@sctimst.ac.in |
Study information
| Study design | Single-centre prospective two-arm randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format |
| Scientific title | Medication adherence and management of risk factors for secondary prevention of stroke using a smartphone-based application: a feasibility study |
| Study acronym | MAMORs |
| Study objectives | The m-health app could improve medication adherence and risk factor control when compared to standard care. |
| Ethics approval(s) | Approved 18/12/2021, Sree Chitra Tirunal Institutional Ethics Committee (Medical College P.O, Thiruvananthapuram -11, India; +91 (0)471 2524689; iec@sctimst.ac.in), ref: SCT/IEC/1791/DECEMBER/2021 |
| Health condition(s) or problem(s) studied | Secondary prevention of stroke among stroke survivors |
| Intervention | Randomization will occur in a 1:1 ratio to either the smartphone group (intervention) or the usual care (control) group. Once the patient meets all study eligibility criteria and signs the consent form, randomization takes place centrally via REDCap software. The patient will not be blinded to procedures as the patient will be verbally informed by the investigator to what treatment group he/she has been assigned. The subjects allocated to the intervention arm will receive a 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 arm 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 control group will receive usual care and health education on stroke, its type, symptoms, risk factors, lifestyle modification, and diets for secondary stroke prevention. They will be given a pamphlet along with their dates of monthly follow-up and visit dates. The patients will be followed up for 6 months, including a direct visit to their treating neurologist in the 3rd and 6th months, and their risk factor values are measured (blood pressure, blood sugar, and lipid profile). |
| Intervention type | Other |
| Primary outcome measure | 1. Medication adherence assessed using the Morisky Medication-Taking Adherence Scale (MMAS 4) at baseline, 3 and 6 months 2. Lifestyle and behavioral factors assessed using WHO STEPS instrument, physical activity questionnaire, and FADS questionnaire at baseline, 3 and 6 months 3. Control of vascular risk factors (fasting blood sugar, HbA1c, lipid profile and blood values) measured using standard techniques in the laboratory at baseline, 3 and 6 months |
| Secondary outcome measures | 1. Vascular events (TIA/stroke/cardiac events/vascular deaths) measured using adverse events data updated within patient medical records at 6 months 2. Functional outcomes measured using the Modified Rankin Scale (mRS) at baseline, 3 and 6 months |
| Overall study start date | 15/11/2021 |
| Completion date | 24/02/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 192 |
| Total final enrolment | 208 |
| Key inclusion criteria | 1. Adult (aged >18 years) patients with onset of stroke within 1 month 2. Severity: Modified Rankin Scale (mRS) <5 3. Presence of one or more vascular risk factors such as hypertension, diabetes mellitus, smoking and dyslipidaemia 4. Patients who could fully understand the use of an Android-based smartphone |
| Key exclusion criteria | 1. Patients with severe disability: mRS >4 2. Patients who do not consent 3. Severe cognitive impairment 4. Stroke survivor without a primary caregiver in patients with mRS 3 and 4 |
| Date of first enrolment | 06/06/2022 |
| Date of final enrolment | 09/09/2022 |
Locations
Countries of recruitment
- India
Study participating centre
Thiruvananthapuram
695011
India
Sponsor information
Research organisation
Rue Francois-Versonnex 7
Geneva
1207
Switzerland
| Phone | +41 (0)22 906 9166 |
|---|---|
| admin@world-stroke.org | |
| Website | https://www.world-stroke.org/ |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 24/02/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The researchers have published the protocol in a medium-impact peer-reviewed journal and intend to publish the main results paper within 3 months of completion of the study in a peer-reviewed high-impact journal. |
| IPD sharing plan | The dataset generated during and/ or analyzed during the current study will be available upon request from Dr P N Sylaja (sylajapn@hotmail.com, sylajapn@sctimst.ac.in). The type of data that will be shared: All the collected data Dates of availability: Until 5 years after the end of the trial Whether consent from participants was required and obtained: Consent was required and was obtained Comments on data anonymization: The name of the participants were anonymised Any ethical or legal restrictions: No Any additional comments: No |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 03/12/2022 | 02/02/2023 | Yes | No | |
| Basic results | 12/03/2024 | No | No |
Additional files
Editorial Notes
12/03/2024: The basic results were uploaded as an additional file.
02/02/2023: Trial's existence confirmed by the Sree Chitra Tirunal Institutional Ethics Committee.
