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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
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 12, 2013
Last Updated
May 4, 2018
Sponsor
Medical University of South Carolina
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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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