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The purpose of this study is to determine whether a culturally-sensitive multipronged post-discharge intervention can significantly reduce blood pressure, enhance achievement of guideline recommended targets for risk factor control, and lower recurrent vascular events in a low-income and middle-income (LMIC). The study will have 2 Phases - a qualitative phase (Phase 1) lasting less than one year involving development of the intervention through focus group methodologies and structured interviews, and a clinical trial phase (Phase 2)lasting 3 years involving a randomized trial testing the efficacy of the intervention.
This research seeks to develop an effective and sustainable way of reducing the devastating and deadly impact of stroke in a low-income region of the world with poor medical infrastructure. It will do so by focusing on improving the treatment of the condition most closely tied to stroke, hypertension, using novel methods that incorporate the input of the local community. If successful, the strategy could serve as a ready model to be adapted by decision-makers in other under-resourced areas for lessening the burden of stroke(and other major public health challenges).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral | Active Comparator |
|
|
| Standard care | No Intervention | Routine and customary management. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THRIVES | Behavioral | Pre-appointment phone text In-clinic educational video Patient report card Post-clinic phone text Outpatient stroke registry |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in systolic blood pressure | Reduction in systolic blood pressure at one year post-discharge in stroke patients. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Reduced rate of subsequent primary vascular event | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of disability and enhanced quality of life. | 1 year |
Phase 1: Inclusion Criteria:
Age ≥ 18 years Stroke within one year access to mobile phone.
Exclusion Criteria:
Any medical condition that would limit participation in follow up assessments, Severe cognitive impairment/dementia (MMSE ≤24) Severe global disability (modified Rankin Score ≥ 3).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sacred Heart Hospital | Abeokuta | Ogun State | Nigeria | |||
| Federal Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31805787 | Derived | Owolabi MO, Gebregziabher M, Akinyemi RO, Akinyemi JO, Akpa O, Olaniyan O, Salako BL, Arulogun O, Tagge R, Uvere E, Fakunle A, Ovbiagele B. Randomized Trial of an Intervention to Improve Blood Pressure Control in Stroke Survivors. Circ Cardiovasc Qual Outcomes. 2019 Dec;12(12):e005904. doi: 10.1161/CIRCOUTCOMES.119.005904. Epub 2019 Dec 6. | |
| 25042605 | Derived | Owolabi MO, Akinyemi RO, Gebregziabher M, Olaniyan O, Salako BL, Arulogun O, Ovbiagele B. Randomized controlled trial of a multipronged intervention to improve blood pressure control among stroke survivors in Nigeria. Int J Stroke. 2014 Dec;9(8):1109-16. doi: 10.1111/ijs.12331. Epub 2014 Jul 18. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Abeokuta |
| Nigeria |
| University College Hospital | Ibadan | Nigeria |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |