Telemedicine Efficacy in Medication Adherence in Post-ischemic Stroke Patients

Sponsor

Fundación Cardiovascular de Colombia (Other)

Overall Status

Recruiting

CT.gov ID

NCT04877171

Collaborator

Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS) (Other)

Enrollment

Location

Arms

13.5

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Compliance, Patient Compliance, Treatment Compliance, Medication	Other: telemedicine neurology consultation Other: in-person neurology consultation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Telemedicine Efficacy in Medication Adherence in Post-ischemic Stroke Patients

Actual Study Start Date :

Jul 16, 2021

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Aug 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: telemedicine neurology consultation consultations via phone-only at 12-14-day post-discharge. Consultations via phone both audio and video at 1, 3 and 6 months
Active Comparator: 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.	Other: in-person neurology consultation consultation in-person at Hospital Internacional de Colombia

Arm

Intervention/Treatment

Experimental: 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.

Other: telemedicine neurology consultation

consultations via phone-only at 12-14-day post-discharge. Consultations via phone both audio and video at 1, 3 and 6 months

Active Comparator: 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.

Other: in-person neurology consultation

consultation in-person at Hospital Internacional de Colombia

Outcome Measures

Primary Outcome Measures

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

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).

Other Outcome Measures

Presence of adverse events related to secondary stroke prevention medication [6 months]
Thirty days after beginning the treatment, and every consultation month thereafter, the participants will be asked about the occurrence of adverse events.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 86 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.