An interventional study of telemedicine neurology consultation and in-person neurology consultation in Stroke, Compliance, Patient and Compliance, Treatment, sponsored by Fundación Cardiovascular de Colombia. Status unknown at 1 site in Colombia. Open to participants aged 18 Years to 86 Years. Per ClinicalTrials.gov, last updated 2021-09-01.
Sponsored by Fundación Cardiovascular de Colombia · Not applicable, Interventional, and Other
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.
7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 84 is above the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →Fundación Cardiovascular de Colombia is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
consultations via phone-only at 12-14-day post-discharge. Consultations via phone both audio and video at 1, 3 and 6 months
consultation in-person at Hospital Internacional de Colombia
Percentage medication adherence through Morisky-Green questionnaire
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.
Time frame: 6 months
The Fantastic lifestyle assessment questionnaire
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).
Time frame: 6 months
Caregiver burden questionnaire
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).
Time frame: 6 months
Presence of adverse events related to secondary stroke prevention medication
Thirty days after beginning the treatment, and every consultation month thereafter, the participants will be asked about the occurrence of adverse events.
Time frame: 6 months
Plan to share: No
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Fundación Cardiovascular de Colombia