Clinical trial NCT04158154: Transforming Hypertension Treatment in Nigeria Using a Type II Hybrid, Interrupted Time Series Design
Official title: Transforming Hypertension Treatment in Nigeria Using a Type II Hybrid, Interrupted Time Series Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Nigeria
Primary Health Center
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Abuja Teaching Hospital
name: Resolve to Save Lives
First posted: 2019-11-08
Enrollment: 21922
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study applies an interrupted time series design.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Slope of Treatment Rate
timeFrame: Through study completion, 45 months
measure: Change from Baseline Slope of Control Rate
timeFrame: Through study completion, 45 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abuja
country: Nigeria
facility: Dakwa PHC
state: Abuja Municipal Area Council
city: Abuja
country: Nigeria
facility: Gbagarape PHC
state: Abuja Municipal Area Council
city: Abuja
country: Nigeria
facility: Gidan Mangoro PHC
state: Abuja Municipal Area Council
city: Abuja
country: Nigeria
facility: Gosa PHC
state: Abuja Municipal Area Council
city: Abuja
country: Nigeria
facility: Gwagwa PHC
state: Abuja Municipal Area Council
city: Abuja
country: Nigeria
facility: Jikwoyi PHC
state: Abuja Municipal Area Council
city: Abuja
country: Nigeria
facility: Kagini PHC
state: Abuja Municipal Area Council
city: Abuja
country: Nigeria
facility: Karon Majigi PHC
state: Abuja Municipal Area Council
city: Abuja
country: Nigeria
facility: Karshi PHC
state: Abuja Municipal Area Council
city: Abuja
country: Nigeria
facility: Karu PHC
state: Abuja Municipal Area Council
city: Abuja
country: Nigeria
facility: Kuchingoro PHC
state: Abuja Municipal Area Council
city: Abuja
country: Nigeria
facility: Lugbe PHC
state: Abuja Municipal Area Council
city: Abuja
country: Nigeria
facility: New Garki Apo PHC
state: Abuja Municipal Area Council
city: Abuja
country: Nigeria
facility: Orozo PHC
state: Abuja Municipal Area Council
city: Abuja
country: Nigeria
facility: Pykassa PHC
state: Abuja Municipal Area Council
city: Abaji
country: Nigeria
facility: Agyana PHC
city: Abaji
country: Nigeria
facility: Central PHC
city: Abaji
country: Nigeria
facility: Gawu PHC
city: Abaji
country: Nigeria
facility: Low Cost PHC
city: Abaji
country: Nigeria
facility: Naharati PHC
city: Abaji
country: Nigeria
facility: New Township Clinic
city: Abaji
country: Nigeria
facility: Rimba PHC
city: Abaji
country: Nigeria
facility: Yaba PHC
city: Bwari
country: Nigeria
facility: Byazhin PHC
city: Bwari
country: Nigeria
facility: Dei-Dei PHC
city: Bwari
country: Nigeria
facility: Kawu PHC
city: Bwari
country: Nigeria
facility: Kogo PHC
city: Bwari
country: Nigeria
facility: Mpape PHC
city: Bwari
country: Nigeria
facility: Sabon Gari PHC
city: Bwari
country: Nigeria
facility: Shere PHC
city: Bwari
country: Nigeria
facility: Ushafa PHC
city: Gwagwalada
country: Nigeria
facility: Anagada PHC
city: Gwagwalada
country: Nigeria
facility: Dagiri CPHC
city: Gwagwalada
country: Nigeria
facility: Dobi PHC
city: Gwagwalada
country: Nigeria
facility: Dukpa PHC
city: Gwagwalada
country: Nigeria
facility: Gwagwalada Township Clinic
city: Gwagwalada
country: Nigeria
facility: Gwako PHC
city: Gwagwalada
country: Nigeria
facility: Old-Kutunku PHC
city: Gwagwalada
country: Nigeria
facility: Paikon PHC
city: Gwagwalada
country: Nigeria
facility: Rafin Zurfi PHC
city: Gwagwalada
country: Nigeria
facility: Yimi PHC
city: Gwagwalada
country: Nigeria
facility: Zuba PHC
city: Kuje
country: Nigeria
facility: Chukuku PHC
city: Kuje
country: Nigeria
facility: Gaube CPHC
city: Kuje
country: Nigeria
facility: Gudunkarya PHC
city: Kuje
country: Nigeria
facility: Gwargada PHC
city: Kuje
country: Nigeria
facility: Kiyi PHC
city: Kuje
country: Nigeria
facility: Kuje PHC
city: Kuje
country: Nigeria
facility: Kujekwa PHC
city: Kuje
country: Nigeria
facility: Pegi PHC
city: Kwali
country: Nigeria
facility: Ashara PHC
city: Kwali
country: Nigeria
facility: Dabi Bako CPHC
city: Kwali
country: Nigeria
facility: Dafa PHC
city: Kwali
country: Nigeria
facility: Gomani PHC
city: Kwali
country: Nigeria
facility: Kwaita Hausa PHC
city: Kwali
country: Nigeria
facility: Kwaita Model PHC
city: Kwali
country: Nigeria
facility: Kwali PHC
city: Kwali
country: Nigeria
facility: Petti PHC
city: Kwali
country: Nigeria
facility: Wako PHC
city: Kwali
country: Nigeria
facility: Yangoji PHC
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Mark D Huffman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Abuja Teaching Hospital
name: Dike B Ojji, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baldridge AS, Aluka-Omitiran K, Orji IA, Shedul GL, Ojo TM, Eze H, Shedul G, Ugwuneji EN, Egenti NB, Okoli RCB, Ale BM, Nwankwo A, Osagie S, Ye J, Chopra A, Sanuade OA, Tripathi P, Kandula NR, Hirschhorn LR, Huffman MD, Ojji DB. Hypertension Treatment in Nigeria (HTN) Program: rationale and design for a type 2 hybrid, effectiveness, and implementation interrupted time series trial. Implement Sci Commun. 2022 Aug 2;3(1):84. doi: 10.1186/s43058-022-00328-9.
citation: Ojji DB, Baldridge AS, Orji IA, Shedul GL, Ojo TM, Ye J, Chopra A, Ale BM, Shedul G, Ugwuneji EN, Egenti NB, Aluka-Omitiran K, Okoli RCB, Eze H, Nwankwo A, Banigbe B, Tripathi P, Kandula NR, Hirschhorn LR, Huffman MD; Hypertension Treatment in Nigeria Program Investigators. Characteristics, treatment, and control of hypertension in public primary healthcare centers in Nigeria: baseline results from the Hypertension Treatment in Nigeria Program. J Hypertens. 2022 May 1;40(5):888-896. doi: 10.1097/HJH.0000000000003089. Epub 2022 Jan 15.