Telemedicine Efficacy in Medication Adherence in Post-ischemic Stroke Patients

August 26, 2021 updated by: Fundación Cardiovascular de Colombia

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Colombia
    • Santander,
      • Piedecuesta, Santander,, Colombia
        • Recruiting
        • Hospital Internacional de Colombia
        • Principal Investigator:
          • Federico A Silva, MD, MSc, MBA
        • Sub-Investigator:
          • Jenny P Garzon, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Fantastic lifestyle assessment questionnaire
Time Frame: 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).
6 months
Caregiver burden questionnaire
Time Frame: 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).
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of adverse events related to secondary stroke prevention medication
Time Frame: 6 months
Thirty days after beginning the treatment, and every consultation month thereafter, the participants will be asked about the occurrence of adverse events.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Cardiovascular de Colombia

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2021

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

August 30, 2022

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

April 30, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 26, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI-2020-01644

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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