Addressing Hypertension Care in Africa Program
- Conditions
- HypertensionHigh Blood Pressure
- Registration Number
- NCT06986590
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
The ADHINCRA Program is a bundle of multilevel evidence-based interventions that address multiple predictors of controlled hypertension, including patient-, provider-, and health system-level factors. The successful implementation of the ADHINCRA program will provide a rigorous and scalable model for improving hypertension control in Africa, which would ultimately reduce the risk of cardiovascular disease, stroke and kidney disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 800
- Aged 18 -70 years.
- Diagnosis of hypertension and elevated systolic blood pressure measure (≥140 mmHg) on the most recent clinic visit (within the previous 6 months) without a diabetes diagnosis.
- Receives primary care at one of the participating sites.
- Willing and able to provide informed consent in English, Twi, Dagbani, Ewe or Yoruba.
- Owns a smartphone (Android or iOS).
- Age <18 years or >70 years.
- Severely elevated BP (≥180/110mmHg).
- Diagnosis of stroke, coronary artery disease, or kidney disease.
- Diagnosis of end-stage renal disease (ESRD) treated with dialysis.
- Serious medical condition which either limits life expectancy or requires active management (e.g., cancer).
- Cognitive impairment or other conditions preventing study participation
- Pregnant or currently nursing a child
- Unwilling to provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Number of participants with systolic blood pressure <140 mmHg Baseline and 12 months post-randomization Blood pressure control among participants defined as systolic blood pressure \<140 mmHg
- Secondary Outcome Measures
Name Time Method Number of participants with diastolic blood pressure <90 mmHg Baseline, 12 months, 24 months post-randomization Blood pressure control as assessed by diastolic blood pressure \<90mmHg
Medication adherence as assessed by Hill-Bone Medication Adherence Scale Baseline, 12 months, 24 months post-randomization Adherence to medications prescribed per the ADHINCRA Program treatment protocol. The total score ranges from 14 - 56. Higher score is better adherence.
Percentage of sites that adopt and maintain the intervention as assessed by the Pragmatic Robust Implementation and Sustainability Model Baseline, 12 months, 24 months post-randomization Use the Pragmatic Robust Implementation and Sustainability Model (PRISM) to evaluate the reach, adoption, maintenance of the ADHINCRA Program
Difference in cost of intervention compared to usual care as assessed by the Pragmatic Robust Implementation and Sustainability Model Baseline, 12 months, 24 months post-randomization Use the Pragmatic Robust Implementation and Sustainability Model (PRISM) to evaluate the cost-effectiveness of the ADHINCRA Program
Trial Locations
- Locations (17)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Dominase SDA Hospital
🇬🇭Bekwai, Ashanti Region, Ghana
Kumasi South Hospital
🇬🇭Kumasi, Ashanti Region, Ghana
Manhyia Government Hospital
🇬🇭Kumasi, Ashanti Region, Ghana
Tafo Government Hospital
🇬🇭Tafo, Ashanti Region, Ghana
Berekum Holy Family Hospital
🇬🇭Berekum, Bono Region, Ghana
St. Johns Hospital
🇬🇭Duayaw Nkwanta, Bono Region, Ghana
Northern Regional Hospital
🇬🇭Tamale, Northern Region, Ghana
Tamale Teaching Hospital
🇬🇭Tamale, Northern Region, Ghana
Ho Municipal Hospital
🇬🇭Ho, Volta Region, Ghana
South Tongu District Hospital
🇬🇭Sogakofe, Volta Region, Ghana
Akure South Hospital
🇳🇬Akure, Ondo State, Nigeria
Akoko North East
🇳🇬Ondo, Ondo State, Nigeria
Akoko North West
🇳🇬Ondo, Ondo State, Nigeria
Akoko South East
🇳🇬Ondo, Ondo State, Nigeria
Akoko South West
🇳🇬Ondo, Ondo State, Nigeria
Owo General Hospital
🇳🇬Owo, Ondo State, Nigeria