Telemedicine Efficacy in Medication Adherence in Post-ischemic Stroke Patients

NCT ID: NCT04877171

Last Updated: 2021-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-16

Study Completion Date

2022-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Compliance, Patient Compliance, Treatment Compliance, Medication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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telemedicine neurology consultation

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.

Group Type EXPERIMENTAL

telemedicine neurology consultation

Intervention Type OTHER

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

in-person 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.

Group Type ACTIVE_COMPARATOR

in-person neurology consultation

Intervention Type OTHER

consultation in-person at Hospital Internacional de Colombia

Interventions

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telemedicine 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

Intervention Type OTHER

in-person neurology consultation

consultation in-person at Hospital Internacional de Colombia

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

OTHER_GOV

Sponsor Role collaborator

Fundación Cardiovascular de Colombia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Internacional de Colombia

Piedecuesta, Santander Department, Colombia

Site Status RECRUITING

Countries

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Colombia

Central Contacts

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Federico A Silva, MD, MSc, MBA

Role: CONTACT

3174358166

References

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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.

Reference Type BACKGROUND
PMID: 26515208 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25123221 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17000937 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8185149 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24322371 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30241499 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27443991 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28716014 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32584654 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31593536 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3945130 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7203086 (View on PubMed)

Other Identifiers

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CEI-2020-01644

Identifier Type: -

Identifier Source: org_study_id

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