Compliance, Medication, Compliance, Patient, Compliance, Treatment, Stroke
Conditions
Keywords
Stroke consultation, Telemedicine, Recovery, Rehabilitation
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.
Interventions
OTHERtelemedicine 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
OTHERin-person neurology consultation
consultation in-person at Hospital Internacional de Colombia
Sponsors
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Fundación Cardiovascular de Colombia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 86 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Colombia
Contacts
Primary ContactFederico A Silva, MD, MSc, MBA
Outcome results
None listed