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Telemedicine Efficacy in Medication Adherence in Post-ischemic Stroke Patients

F

Fundación Cardiovascular de Colombia

Status

Unknown

Conditions

Compliance, Treatment
Stroke
Compliance, Patient
Compliance, Medication

Treatments

Other: in-person neurology consultation
Other: telemedicine neurology consultation

Study type

Interventional

Funder types

Other

Identifiers

NCT04877171
CEI-2020-01644

Details and patient eligibility

About

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.

Enrollment

84 estimated patients

Sex

All

Ages

18 to 86 years old

Volunteers

No 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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

84 participants in 2 patient groups

telemedicine neurology consultation
Experimental group
Description:
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.
Treatment:
Other: telemedicine neurology consultation
in-person neurology consultation
Active Comparator group
Description:
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.
Treatment:
Other: in-person neurology consultation

Trial contacts and locations

1

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Central trial contact

Federico A Silva, MD, MSc, MBA

Data sourced from clinicaltrials.gov

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