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| Name | Class |
|---|---|
| Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Federico A Silva, MD, MSc, MBA | Contact | 3174358166 | federicosilva@fcv.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Internacional de Colombia | Recruiting | Piedecuesta | Santander Department | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26515208 | Background | 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. | |
| 25123221 | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010349 | Patient Compliance |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| in-person neurology consultation | Other | consultation in-person at Hospital Internacional de Colombia |
|
| 6 months |
| 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 |
| 17000937 | 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. |
| 8185149 | 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. |
| 24322371 | 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. |
| 30241499 | 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. |
| 27443991 | 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. |
| 28716014 | 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. |
| 32584654 | 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. |
| 31593536 | 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. |
| 3945130 | 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. |
| 7203086 | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |