High Blood Pressure, Hypertension
Conditions
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.
Interventions
BEHAVIORALADHINCRA Program
The ADHINCRA Program is a nurse-led intervention that includes the use of home blood pressure monitoring, a mobile health app, lifestyle counselling, and a simplified hypertension treatment protocol to achieve blood pressure control among people diagnosed with hypertension.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Stepped wedge cluster randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18 -70 years. * Diagnosis of hypertension and elevated systolic blood pressure measure (≥140 mmHg) on the most recent clinic visit without a diabetes diagnosis. * Hypertension treatment naive or on monotherapy. * Receives primary care at one of the participating sites. * Willing and able to provide informed consent in English, Twi, Dagbani, Ewe, Hausa, or Yoruba. * Owns a smartphone (Android or iOS).
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Ghana, Nigeria, United States
Contacts
Primary ContactYvonne Commodore-Mensah, PhD, MHS, RN
Backup ContactResearch Program Manager
Outcome results
None listed