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NCT04158154 Clinical Trial

Transforming Hypertension Treatment in Nigeria Using a Type II Hybrid, Interrupted Time Series Design

Hypertension Clinical Trial

— HTN  

Official title:
Transforming Hypertension Treatment in Nigeria Using a Type II Hybrid, Interrupted Time Series Design

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04158154
Other study ID # UATH/HREC/PR/2019/002
Secondary ID 1R01HL144708-01
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date February 28, 2025

Study information
Verified date March 2024
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Active, not recruiting
Enrollment 57600
Est. completion date February 28, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Evidence-based fixed-dose combination protocol based treatment
The intervention has been adapted based on a local needs' assessment including exploration of health care workers and patient's knowledge, attitudes, and behaviors related to HTN, causes, consequences, and treatment. Implementation pathways have been developed with particular attention to overcoming modifiable barriers to HTN treatment and control across capability, intentional, and system domains using CFIR. Sites will randomly be assigned to receive either: Step 1 amlodipine 5mg; Step 2 amlodipine 5 mg + losartan 50 mg (as 2 separate pills); Step 3 amlodipine 10 mg + losartan 100 mg (as 4 separate pills); Step 4 amlodipine 10/losartan 100/HCTZ 25 (as 2 single pill combo) or Step 1 amlodipine 5mg; Step 2 amlodipine 5 mg + losartan 50 mg (as 1 single pill combo); Step 3 amlodipine 10 mg + losartan 100 mg (as 2 single pill combo); Step 4 amlodipine 10/losartan 100/HCTZ 25 (as 2 single pill combo).

Locations
Country Name City State
Nigeria Agyana PHC Abaji
Nigeria Central PHC Abaji
Nigeria Gawu PHC Abaji
Nigeria Low Cost PHC Abaji
Nigeria Naharati PHC Abaji
Nigeria New Township Clinic Abaji
Nigeria Rimba PHC Abaji
Nigeria Yaba PHC Abaji
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 Gwagwa PHC Abuja Abuja Municipal Area Council
Nigeria Jikwoyi PHC Abuja Abuja Municipal Area Council
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 Karu PHC Abuja Abuja Municipal Area Council
Nigeria Kuchingoro PHC Abuja Abuja Municipal Area Council
Nigeria Lugbe PHC Abuja Abuja Municipal Area Council
Nigeria New Garki Apo PHC Abuja Abuja Municipal Area Council
Nigeria Orozo PHC Abuja Abuja Municipal Area Council
Nigeria Pykassa PHC Abuja Abuja Municipal Area Council
Nigeria Byazhin PHC Bwari
Nigeria Dei-Dei PHC Bwari
Nigeria Kawu PHC Bwari
Nigeria Kogo PHC Bwari
Nigeria Mpape PHC Bwari
Nigeria Sabon Gari PHC Bwari
Nigeria Shere PHC Bwari
Nigeria Ushafa PHC Bwari
Nigeria Anagada PHC Gwagwalada
Nigeria Dagiri CPHC Gwagwalada
Nigeria Dobi PHC Gwagwalada
Nigeria Dukpa PHC Gwagwalada
Nigeria Gwagwalada Township Clinic Gwagwalada
Nigeria Gwako PHC Gwagwalada
Nigeria Old-Kutunku PHC Gwagwalada
Nigeria Paikon PHC Gwagwalada
Nigeria Rafin Zurfi PHC Gwagwalada
Nigeria Yimi PHC Gwagwalada
Nigeria Zuba PHC Gwagwalada
Nigeria Chukuku PHC Kuje
Nigeria Gaube CPHC Kuje
Nigeria Gudunkarya PHC Kuje
Nigeria Gwargada PHC Kuje
Nigeria Kiyi PHC Kuje
Nigeria Kuje PHC Kuje
Nigeria Kujekwa PHC Kuje
Nigeria Pegi PHC Kuje
Nigeria Ashara PHC Kwali
Nigeria Dabi Bako CPHC Kwali
Nigeria Dafa PHC Kwali
Nigeria Gomani PHC Kwali
Nigeria Kwaita Hausa PHC Kwali
Nigeria Kwaita Model PHC Kwali
Nigeria Kwali PHC Kwali
Nigeria Petti PHC Kwali
Nigeria Wako PHC Kwali
Nigeria Yangoji PHC Kwali

Sponsors (4)
Lead Sponsor Collaborator
Washington University School of Medicine National Heart, Lung, and Blood Institute (NHLBI), Resolve to Save Lives, University of Abuja Teaching Hospital

Country where clinical trial is conducted

Nigeria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Baseline Slope of Treatment Rate Hypertension treatment using any blood pressure lowering drug. Treatments rates are calculated monthly, over 9 months of baseline and 39 months of intervention. Through study completion, 45 months
Primary Change from Baseline Slope of Control Rate 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. Through study completion, 45 months
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