Telemedicine Efficacy in Medication Adherence in Post-ischemic Stroke Patients

Not Applicable

• Conditions: Compliance, Treatment; Compliance, Medication; Compliance, Patient; Stroke
• Interventions: Other: telemedicine neurology consultation; Other: in-person neurology consultation

• Registration Number: NCT04877171
• Lead Sponsor: Fundación Cardiovascular de Colombia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-26
• Study First Submitted QC: 2021-04-30
• Study First Posted: 2021-05-07
• Study Start: 2021-07-16
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-26
• Last Update Posted: 2021-09-01
• Primary Completion: 2022-07-31
• Study Completion: 2022-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
telemedicine neurology consultation	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.
in-person neurology consultation	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.

Primary Outcome Measures

Name	Time	Method
Percentage medication adherence through Morisky-Green questionnaire	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 Outcome Measures

Name	Time	Method
The Fantastic lifestyle assessment questionnaire	6 months	The fantastic instrument consists of a questionnaire with 25 closed-end questions across nine domains of the physical, psychological, and social components of lifestyle. The 23 first questions have multiple-choice (five answers) and the last two are dichotomous. The sum of all points yields a total score that classifies individuals in five categories, as follows: "Excellent" (85 to 100 points), "Very good" (70 to 84 points), "Good" (55 to 69 points), "Regular" (35 to 54 points), and "Needing improvement" (0 to 34 points).
Caregiver burden questionnaire	6 months	The Zarit Burden instrument contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always) with the sum of scores ranging between 0-88. Higher scores are taken to indicate increased burden intensity (score: ≤21=no burden; 21-40 = mild burden; 41-60 = moderate burden; ≥61 = severe burden).

Trial Locations

Locations (1)

Hospital Internacional de Colombia; 🇨🇴 Piedecuesta, Santander,, Colombia