Clinical trial NCT04877171: Telemedicine Efficacy in Medication Adherence in Post-ischemic Stroke Patients
Official title: Telemedicine Efficacy in Medication Adherence in Post-ischemic Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Compliance, Patient
Compliance, Treatment
Compliance, Medication
Keywords: Stroke consultation
Telemedicine
Recovery
Rehabilitation
Lead sponsor: Fundación Cardiovascular de Colombia
Sponsor class: OTHER
Collaborators: name: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
First posted: 2021-05-07
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage medication adherence through Morisky-Green questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: The Fantastic lifestyle assessment questionnaire
timeFrame: 6 months
measure: Caregiver burden questionnaire
timeFrame: 6 months
Other outcomes:
measure: Presence of adverse events related to secondary stroke prevention medication
timeFrame: 6 months
Locations:
city: Piedecuesta
country: Colombia
facility: Hospital Internacional de Colombia
state: Santander,
Study officials:
References:
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