Telemedicine Efficacy in Medication Adherence in Post-ischemic Stroke Patients

NCT04877171 | Unknown DMC

• 1 other identifier: CEI-2020-01644
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Compliance, Patient; Compliance, Treatment; Compliance, Medication

Keywords

Stroke consultation; Telemedicine; Recovery; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (2)

• The Fantastic lifestyle assessment questionnaire

  6 months

• Caregiver burden questionnaire

  6 months

Other Outcomes (1)

• Presence of adverse events related to secondary stroke prevention medication

  6 months

Study Arms (2)

telemedicine neurology consultation

EXPERIMENTAL

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

in-person neurology consultation

ACTIVE COMPARATOR

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

Interventions

telemedicine neurology consultation OTHER

consultations via phone-only at 12-14-day post-discharge. Consultations via phone both audio and video at 1, 3 and 6 months

telemedicine neurology consultation

in-person neurology consultation OTHER

consultation in-person at Hospital Internacional de Colombia

in-person neurology consultation

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Cardiovascular de Colombia: lead
• Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS): collaborator

Study Sites (1)

Hospital Internacional de Colombia

Piedecuesta, Santander Department, Colombia

RECRUITING

Related Publications (12)

• Broderick JP, Abir M. Transitions of Care for Stroke Patients: Opportunities to Improve Outcomes. Circ Cardiovasc Qual Outcomes. 2015 Oct;8(6 Suppl 3):S190-2. doi: 10.1161/CIRCOUTCOMES.115.002288. No abstract available.

  PMID: 26515208 BACKGROUND

• Kalanithi L, Tai W, Conley J, Platchek T, Zulman D, Milstein A. Better health, less spending: delivery innovation for ischemic cerebrovascular disease. Stroke. 2014 Oct;45(10):3105-11. doi: 10.1161/STROKEAHA.114.006236. Epub 2014 Aug 14. No abstract available.

  PMID: 25123221 BACKGROUND

• Coleman EA, Parry C, Chalmers S, Min SJ. The care transitions intervention: results of a randomized controlled trial. Arch Intern Med. 2006 Sep 25;166(17):1822-8. doi: 10.1001/archinte.166.17.1822.

  PMID: 17000937 BACKGROUND

• Naylor M, Brooten D, Jones R, Lavizzo-Mourey R, Mezey M, Pauly M. Comprehensive discharge planning for the hospitalized elderly. A randomized clinical trial. Ann Intern Med. 1994 Jun 15;120(12):999-1006. doi: 10.7326/0003-4819-120-12-199406150-00005.

  PMID: 8185149 BACKGROUND

• Poston KM, Dumas BP, Edlund BJ. Outcomes of a quality improvement project implementing stroke discharge advocacy to reduce 30-day readmission rates. J Nurs Care Qual. 2014 Jul-Sep;29(3):237-44. doi: 10.1097/NCQ.0000000000000040.

  PMID: 24322371 BACKGROUND

• Ogren J, Irewall AL, Soderstrom L, Mooe T. Long-term, telephone-based follow-up after stroke and TIA improves risk factors: 36-month results from the randomized controlled NAILED stroke risk factor trial. BMC Neurol. 2018 Sep 21;18(1):153. doi: 10.1186/s12883-018-1158-5.

  PMID: 30241499 BACKGROUND

• Cameron JI, O'Connell C, Foley N, Salter K, Booth R, Boyle R, Cheung D, Cooper N, Corriveau H, Dowlatshahi D, Dulude A, Flaherty P, Glasser E, Gubitz G, Hebert D, Holzmann J, Hurteau P, Lamy E, LeClaire S, McMillan T, Murray J, Scarfone D, Smith EE, Shum V, Taylor K, Taylor T, Yanchula C, Teasell R, Lindsay P; Heart and Stroke Foundation Canadian Stroke Best Practice Committees. Canadian Stroke Best Practice Recommendations: Managing transitions of care following Stroke, Guidelines Update 2016. Int J Stroke. 2016 Oct;11(7):807-22. doi: 10.1177/1747493016660102. Epub 2016 Jul 21.

  PMID: 27443991 BACKGROUND

• Duncan PW, Bushnell CD, Rosamond WD, Jones Berkeley SB, Gesell SB, D'Agostino RB Jr, Ambrosius WT, Barton-Percival B, Bettger JP, Coleman SW, Cummings DM, Freburger JK, Halladay J, Johnson AM, Kucharska-Newton AM, Lundy-Lamm G, Lutz BJ, Mettam LH, Pastva AM, Sissine ME, Vetter B. The Comprehensive Post-Acute Stroke Services (COMPASS) study: design and methods for a cluster-randomized pragmatic trial. BMC Neurol. 2017 Jul 17;17(1):133. doi: 10.1186/s12883-017-0907-1.

  PMID: 28716014 BACKGROUND

• Ross L, Bena J, Bermel R, McCarter L, Ahmed Z, Goforth H, Cherian N, Kriegler J, Estemalik E, Stanton M, Rasmussen P, Fernandez HH, Najm I, McGinley M. Implementation and Patient Experience of Outpatient Teleneurology. Telemed J E Health. 2021 Mar;27(3):323-329. doi: 10.1089/tmj.2020.0032. Epub 2020 Jun 23.

  PMID: 32584654 BACKGROUND

• Appireddy R, Khan S, Leaver C, Martin C, Jin A, Durafourt BA, Archer SL. Home Virtual Visits for Outpatient Follow-Up Stroke Care: Cross-Sectional Study. J Med Internet Res. 2019 Oct 7;21(10):e13734. doi: 10.2196/13734.

  PMID: 31593536 BACKGROUND

• Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.

  PMID: 3945130 BACKGROUND

• Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.

  PMID: 7203086 BACKGROUND

MeSH Terms

Conditions

Stroke; Patient Compliance; Medication Adherence

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Federico A Silva, MD, MSc, MBA

CONTACT

3174358166; federicosilva@fcv.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 7, 2021
• Study Start: July 16, 2021
• Primary Completion: July 31, 2022
• Study Completion: August 30, 2022
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)