Tailored Hospital-based Risk Reduction to Impede Vascular Events After Stroke (THRIVES)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
THRIVES
Sponsored by

About this trial
This is an interventional prevention trial for Stroke
Eligibility Criteria
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).
Sites / Locations
- Sacred Heart Hospital
- Federal Medical Centre
- University College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Behavioral
Standard care
Arm Description
Pre-appointment phone text In-clinic educational video Patient report card Post-clinic phone text Outpatient stroke registry
Routine and customary management.
Outcomes
Primary Outcome Measures
Reduction in systolic blood pressure
Reduction in systolic blood pressure at one year post-discharge in stroke patients.
Secondary Outcome Measures
Reduced rate of subsequent primary vascular event
Full Information
NCT ID
NCT01900756
First Posted
July 12, 2013
Last Updated
May 4, 2018
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT01900756
Brief Title
Tailored Hospital-based Risk Reduction to Impede Vascular Events After Stroke
Acronym
THRIVES
Official Title
Tailored Hospital-based Risk Reduction to Impede Vascular Events After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral
Arm Type
Active Comparator
Arm Description
Pre-appointment phone text
In-clinic educational video
Patient report card
Post-clinic phone text
Outpatient stroke registry
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Routine and customary management.
Intervention Type
Behavioral
Intervention Name(s)
THRIVES
Intervention Description
Pre-appointment phone text In-clinic educational video Patient report card Post-clinic phone text Outpatient stroke registry
Primary Outcome Measure Information:
Title
Reduction in systolic blood pressure
Description
Reduction in systolic blood pressure at one year post-discharge in stroke patients.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Reduced rate of subsequent primary vascular event
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Reduction of disability and enhanced quality of life.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Sacred Heart Hospital
City
Abeokuta
State/Province
Ogun
Country
Nigeria
Facility Name
Federal Medical Centre
City
Abeokuta
Country
Nigeria
Facility Name
University College Hospital
City
Ibadan
Country
Nigeria
12. IPD Sharing Statement
Citations:
PubMed Identifier
31805787
Citation
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.
Results Reference
derived
PubMed Identifier
25042605
Citation
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.
Results Reference
derived
Learn more about this trial
Tailored Hospital-based Risk Reduction to Impede Vascular Events After Stroke
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