Telemedicine Efficacy in Medication Adherence in Post-ischemic Stroke Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Percentage medication adherence through Morisky-Green questionnaire
Study Overview
Brief Summary
Telemedicine is an incipient resource to support the stroke system of care in Colombia. Several studies had demonstrated that patients benefit by implementing telestroke, for instance, providing timely and appropriate neurological consultation, diminishing accessible barriers, improving medication adherence for secondary prevention and facilitating linkages between patient and physician, especially for those in rural or neurologically underserved areas.
Hypothesis: The use of Telemedicine improves medication adherence in Post-ischemic Stroke.
Study Design: This is a randomized, single-blind, clinical trial to assess the efficacy of Telemedicine, over medication adherence in Post-ischemic Stroke subjects from Colombia.
Population: Eighty-four Post-ischemic Stroke subjects, subjects of both genders, over 18 years old, with a first stroke will be included.
Ethical Aspects: The study will be conducted according to the Helsinki declaration, the good clinical practices guidelines and the Colombian legislation. Prior to entering the study, patients must sign a written or oral informed consent that has been approved by the Institutional Ethics Committee of Fundación Cardiovascular de Colombia.
Overall objective: this study aims to determine the efficacy of telemedicine on pharmacological adherence in post-ischemic Stroke Participants.
Focus of study: Adherence to secondary stroke prevention medication.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 86 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •First ischemic stroke.
- •Lived in urban areas.
- •Available Access to permanent internet at home, in work on mobile dispositive, computers or tablets.
- •Patients who gave their written informed consent.
Exclusion Criteria
- •Diagnosis of neurodegenerative diseases such as dementia and Parkinson's disease.
- •Diagnosis of Diseases-terminal to prevent tracking.
- •Diagnosis of psychiatric illnesses such as major depressive disorder (MDD) or others.
- •Global cognitive impairment or previous diagnosis of dementia.
Arms & Interventions
telemedicine neurology consultation
Starting on day 12-14 post-discharge, participants will receive a phone call for a drug conciliation. Participants at 1-month post-discharge will receive a telemedicine consultation, another at 3 months and 6 months.
Intervention: telemedicine neurology consultation (Other)
in-person neurology consultation
Starting at 1-month post-discharge, participants will attend an in-person neurology consultation and the following consultations depend on their physician's criteria until completed 6 months post-discharge.
Intervention: in-person neurology consultation (Other)
Outcomes
Primary Outcomes
Percentage medication adherence through Morisky-Green questionnaire
Time Frame: 6 months
The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behavior. It consists of 4 items, with binary scoring (yes/no). Patients score one point for every 'Yes' answer. A score of 0 indicates high adherence; a score of 1 or 2 indicates intermediate adherence, and a score of 3 or 4 indicates low adherence.
Secondary Outcomes
- The Fantastic lifestyle assessment questionnaire(6 months)
- Caregiver burden questionnaire(6 months)