Transforming Hypertension Treatment in Nigeria Using a Type II Hybrid, Interrupted Time Series Design
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 21,922
- Locations
- 60
- Primary Endpoint
- Change from Baseline Slope of Treatment Rate
Study Overview
Brief Summary
The purpose of the Transforming Hypertension Treatment in Nigeria Program is to improve awareness, treatment, and control of hypertension in Nigeria through the adaptation, implementation, and evaluation of the effectiveness and implementation of a system-level hypertension control program.
Detailed Description
This study includes the implementation and evaluation of a culturally- and contextually-adapted intervention package based on the Kaiser Permanente Northern California and World Health Organization HEARTS programs for hypertension diagnosis and treatment at primary health centers in Abuja, Nigeria. The intervention has been adapted based on a local needs' assessment including evidence synthesis and specific exploration of health care workers' knowledge, attitudes, and behaviors related to hypertension, causes, consequences, and treatment, including fixed-dose combination and patient self-management, and patients' knowledge, attitudes, and behaviors related to hypertension, causes, consequences, and treatment. Implementation pathways have been developed with particular attention to overcoming modifiable system- and patient-level barriers to hypertension treatment and control across capability, intentional, and system domains using the Consolidated Framework for Implementation Research. Preparedness and capacity have been assessed at primary health centers (e.g. available staff; information systems; use of clinical guidelines) through an adapted Service Availability and Readiness Assessment (SARA) instrument during the formative work for this study. The multi-level implementation package includes: 1) patient registration and empanelment (health system level), 2) standard treatment protocol (national policy level), 3) encouragement of fixed-dose combination therapy (health system level), 4) team-based care (health worker level), and 5) home blood pressure monitoring and health coaching (patient-level).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults (≥18 years).
- •Elevated blood pressure (Systolic Blood Pressure ≥ 130 mmHg or Diastolic Blood Pressure ≥ 80 mmHg) documented or measured by a health care professional (e.g., physician, Community Health Extension Worker, or Community Health Officer).
Exclusion Criteria
- •Individuals who are not yet adults (minors)
- •Prisoners or other detained individuals.
Arms & Interventions
Primary Health Care Centers
Selected primary health care centers in Abuja will implement a culturally- and contextually-adapted intervention package based on the Kaiser Permanente Northern California and World Health Organization HEARTS programs for hypertension diagnosis and treatment.
Intervention: Evidence-based fixed-dose combination protocol based treatment (Other)
Outcomes
Primary Outcomes
Change from Baseline Slope of Treatment Rate
Time Frame: Through study completion, 45 months
Hypertension treatment using any blood pressure lowering drug. Treatments rates are calculated monthly, over 9 months of baseline and 39 months of intervention.
Change from Baseline Slope of Control Rate
Time Frame: Through study completion, 45 months
Hypertension control is defined as a Systolic Blood Pressure \<140 mmHg and Diastolic Blood Pressure \<90 mmHg. Control rates are calculated monthly, over 9 months of baseline and 39 months of intervention.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mark Huffman
Professor of Medicine and Global Health Center Co-Director
Washington University School of Medicine