Addressing Hypertension Care in Africa Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
ADHINCRA Program
BehavioralThe 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.
Treatment groups
800 Participants
are divided into 4 treatment groupsGroup A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention
Group D: Cohort 4Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with systolic blood pressure <140 mmHg
Blood pressure control among participants defined as systolic blood pressure \<140 mmHg
Time frame
Baseline and 12 months post-randomizationSecondary outcomes
1
Number of participants with diastolic blood pressure <90 mmHg
Blood pressure control as assessed by diastolic blood pressure \<90mmHg
Time frame
Baseline, 12 months, 24 months post-randomization2
Medication adherence as assessed by Hill-Bone Medication Adherence Scale
Adherence to medications prescribed per the ADHINCRA Program treatment protocol. The total score ranges from 14 - 56. Higher score is better adherence.
Time frame
Baseline, 12 months, 24 months post-randomization3
Percentage of sites that adopt and maintain the intervention as assessed by the Pragmatic Robust Implementation and Sustainability Model
Use the Pragmatic Robust Implementation and Sustainability Model (PRISM) to evaluate the reach, adoption, maintenance of the ADHINCRA Program
Time frame
Baseline, 12 months, 24 months post-randomization4
Difference in cost of intervention compared to usual care as assessed by the Pragmatic Robust Implementation and Sustainability Model
Use the Pragmatic Robust Implementation and Sustainability Model (PRISM) to evaluate the cost-effectiveness of the ADHINCRA Program
Time frame
Baseline, 12 months, 24 months post-randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov