Transforming Hypertension Treatment in Nigeria Using a Type II Hybrid, Interrupted Time Series Design
- Conditions
- Hypertension
- Interventions
- Other: Evidence-based fixed-dose combination protocol based treatment
- Registration Number
- NCT04158154
- Lead Sponsor
- Washington University School of Medicine
- 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 57600
- 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).
- Individuals who are not yet adults (minors)
- Prisoners or other detained individuals.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Primary Health Care Centers Evidence-based fixed-dose combination protocol based treatment 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.
- Primary Outcome Measures
Name Time Method Change from Baseline Slope of Treatment Rate 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 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (60)
Central PHC
🇳🇬Abaji, Nigeria
Paikon PHC
🇳🇬Gwagwalada, Nigeria
Yimi PHC
🇳🇬Gwagwalada, Nigeria
Zuba PHC
🇳🇬Gwagwalada, Nigeria
Kiyi PHC
🇳🇬Kuje, Nigeria
Kawu PHC
🇳🇬Bwari, Nigeria
Chukuku PHC
🇳🇬Kuje, Nigeria
Jikwoyi PHC
🇳🇬Abuja, Abuja Municipal Area Council, Nigeria
Dakwa PHC
🇳🇬Abuja, Abuja Municipal Area Council, Nigeria
Gbagarape PHC
🇳🇬Abuja, Abuja Municipal Area Council, Nigeria
Gidan Mangoro PHC
🇳🇬Abuja, Abuja Municipal Area Council, Nigeria
Gosa PHC
🇳🇬Abuja, Abuja Municipal Area Council, Nigeria
New Garki Apo PHC
🇳🇬Abuja, Abuja Municipal Area Council, Nigeria
Lugbe PHC
🇳🇬Abuja, Abuja Municipal Area Council, Nigeria
Orozo PHC
🇳🇬Abuja, Abuja Municipal Area Council, Nigeria
Sabon Gari PHC
🇳🇬Bwari, Nigeria
Gwagwalada Township Clinic
🇳🇬Gwagwalada, Nigeria
Gwako PHC
🇳🇬Gwagwalada, Nigeria
Rafin Zurfi PHC
🇳🇬Gwagwalada, Nigeria
Gudunkarya PHC
🇳🇬Kuje, Nigeria
Kujekwa PHC
🇳🇬Kuje, Nigeria
Gwagwa PHC
🇳🇬Abuja, Abuja Municipal Area Council, Nigeria
Low Cost PHC
🇳🇬Abaji, Nigeria
Rimba PHC
🇳🇬Abaji, Nigeria
Kagini PHC
🇳🇬Abuja, Abuja Municipal Area Council, Nigeria
Karon Majigi PHC
🇳🇬Abuja, Abuja Municipal Area Council, Nigeria
Karshi PHC
🇳🇬Abuja, Abuja Municipal Area Council, Nigeria
Agyana PHC
🇳🇬Abaji, Nigeria
Dei-Dei PHC
🇳🇬Bwari, Nigeria
Kogo PHC
🇳🇬Bwari, Nigeria
Shere PHC
🇳🇬Bwari, Nigeria
Old-Kutunku PHC
🇳🇬Gwagwalada, Nigeria
Dafa PHC
🇳🇬Kwali, Nigeria
Gaube CPHC
🇳🇬Kuje, Nigeria
Gwargada PHC
🇳🇬Kuje, Nigeria
Gomani PHC
🇳🇬Kwali, Nigeria
Kwaita Model PHC
🇳🇬Kwali, Nigeria
Kwali PHC
🇳🇬Kwali, Nigeria
Petti PHC
🇳🇬Kwali, Nigeria
Karu PHC
🇳🇬Abuja, Abuja Municipal Area Council, Nigeria
Kuchingoro PHC
🇳🇬Abuja, Abuja Municipal Area Council, Nigeria
New Township Clinic
🇳🇬Abaji, Nigeria
Ushafa PHC
🇳🇬Bwari, Nigeria
Dagiri CPHC
🇳🇬Gwagwalada, Nigeria
Dobi PHC
🇳🇬Gwagwalada, Nigeria
Pegi PHC
🇳🇬Kuje, Nigeria
Yaba PHC
🇳🇬Abaji, Nigeria
Pykassa PHC
🇳🇬Abuja, Abuja Municipal Area Council, Nigeria
Gawu PHC
🇳🇬Abaji, Nigeria
Naharati PHC
🇳🇬Abaji, Nigeria
Byazhin PHC
🇳🇬Bwari, Nigeria
Mpape PHC
🇳🇬Bwari, Nigeria
Anagada PHC
🇳🇬Gwagwalada, Nigeria
Dukpa PHC
🇳🇬Gwagwalada, Nigeria
Kuje PHC
🇳🇬Kuje, Nigeria
Ashara PHC
🇳🇬Kwali, Nigeria
Dabi Bako CPHC
🇳🇬Kwali, Nigeria
Wako PHC
🇳🇬Kwali, Nigeria
Kwaita Hausa PHC
🇳🇬Kwali, Nigeria
Yangoji PHC
🇳🇬Kwali, Nigeria