Tailored Hospital-based Risk Reduction to Impede Vascular Events After Stroke

NCT01900756 | Completed

• 1 other identifier: 1U01NS079179
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Reduction in systolic blood pressure

  Reduction in systolic blood pressure at one year post-discharge in stroke patients.

  1 year

Secondary Outcomes (1)

• Reduced rate of subsequent primary vascular event

  1 year

Other Outcomes (1)

• Reduction of disability and enhanced quality of life.

  1 year

Study Arms (2)

Behavioral

ACTIVE COMPARATOR

1. Pre-appointment phone text 2. In-clinic educational video 3. Patient report card 4. Post-clinic phone text 5. Outpatient stroke registry

Behavioral: THRIVES

Standard care

NO INTERVENTION

Routine and customary management.

Interventions

THRIVES BEHAVIORAL

Pre-appointment phone text In-clinic educational video Patient report card Post-clinic phone text Outpatient stroke registry

Behavioral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years Stroke within one year access to mobile phone.

You may not qualify if:

• Any medical condition that would limit participation in follow up assessments, Severe cognitive impairment/dementia (MMSE ≤24) Severe global disability (modified Rankin Score ≥ 3).

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (3)

Sacred Heart Hospital

Abeokuta, Ogun State, Nigeria

Location

Federal Medical Centre

Abeokuta, Nigeria

Location

University College Hospital

Ibadan, Nigeria

Location

Related Publications (2)

• 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.

  PMID: 31805787 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.

  PMID: 25042605 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: July 16, 2013
• Study Start: September 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: May 7, 2018

Record last verified: 2018-05

Locations

NG (3)