Telemedicine Efficacy in Medication Adherence in Post-ischemic Stroke Patients

Stroke Clinical Trial

Official title:

Telemedicine Efficacy in Medication Adherence in Post-ischemic Stroke Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04877171
• Other study ID #: CEI-2020-01644
• Status: Recruiting
• Phase: N/A
• Start date: July 16, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: August 2021
• Source: Fundación Cardiovascular de Colombia
• Contact: Federico A Silva, MD, MSc, MBA
• Phone: 3174358166
• Email: federicosilva[@]fcv.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: August 30, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 86 Years

Eligibility

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.

Related Conditions & MeSH terms

• Compliance, Medication
• Compliance, Patient
• Compliance, Treatment
• Stroke

Intervention

Other:
• 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
• in-person neurology consultation
consultation in-person at Hospital Internacional de Colombia

Locations

Country	Name	City	State
Colombia	Hospital Internacional de Colombia	Piedecuesta	Santander,

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Cardiovascular de Colombia	Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

Country where clinical trial is conducted

Colombia, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ögren J, Irewall AL, Söderström 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. — View Citation

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. — View Citation

Ross L, Bena J, Bermel R, et al. Implementation and Patient Experience of Outpatient Teleneurology [published online ahead of print, 2020 Jun 23]. Telemed J E Health. 2020;10.1089/tmj.2020.0032.

Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Presence of adverse events related to secondary stroke prevention medication	Thirty days after beginning the treatment, and every consultation month thereafter, the participants will be asked about the occurrence of adverse events.	6 months
Primary	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	The Fantastic lifestyle assessment questionnaire	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).	6 months
Secondary	Caregiver burden questionnaire	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).	6 months