Medication adherence and management of risk factors for secondary prevention of stroke using smart phone- based application: A feasibility study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 192
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Time Frame: Baseline, Three months and Six months
2. Control of vascular risk factors
Time Frame: Baseline, Three months and Six months
Secondary Outcomes
- 1. Vascularevents-TIA/Stroke/Cardiac events/Vascular deaths(2. Functional outcome-assessed by mRS)