ADHINCRA Program for High Blood Pressure

(ADHINCRA Trial)

Recruiting at 16 trial locations

Overseen By Research Program Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Stroke, Coronary artery disease, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

800 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

Yvonne Commodore-Mensah, PhD, MHS, RN

Principal Investigator

Johns Hopkins University

Dike B Ojji, MBBS, PhD, FWACP

Principal Investigator

University of Abuja

Fred S Sarfo, MBBS, PhD, FWACP

Principal Investigator

Kwame Nkrumah University of Science and Technology

Eligibility Criteria

This trial is for individuals with hypertension (high blood pressure). It's designed to help those who could benefit from a comprehensive approach that tackles patient, provider, and health system factors. Specific eligibility details are not provided.

Inclusion Criteria

I have high blood pressure but do not have diabetes.

Receives primary care at one of the participating sites

I can give consent in English, Twi, Dagbani, Ewe, or Yoruba.

Exclusion Criteria

Unwilling to provide informed consent

I have been diagnosed with stroke, heart disease, or kidney disease.

I am on dialysis for end-stage kidney disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in Cohort 1 begin the ADHINCRA Program, which includes home blood pressure monitoring, an mHealth app, nurse-led lifestyle counselling, and treatment with a simplified hypertension control protocol

12 months

Follow-up

Participants are monitored for blood pressure control and medication adherence

12 months

Extension

Continued monitoring and evaluation of intervention adoption and maintenance

24 months

Treatment Details

Interventions

• ADHINCRA Program

Trial Overview The ADHINCRA Program being tested is a set of interventions aimed at improving the management of high blood pressure. The goal is to create an effective model in Africa for better hypertension control and reduce risks of heart disease, stroke, and kidney damage.

Participant Groups

Group I: Cohort 4 Experimental Treatment 1 Intervention

This cohort will begin the ADHINCRA Program 9 months after Cohort 1.

Group II: Cohort 3 Experimental Treatment 1 Intervention

This cohort will begin the ADHINCRA Program 6 months after Cohort 1.

Group III: Cohort 2 Experimental Treatment 1 Intervention

This cohort will begin the ADHINCRA Program 3 months after Cohort 1.

Group IV: Cohort 1 Experimental Treatment 1 Intervention

This cohort will be the first to participate in the ADHINCRA Program, which includes home blood pressure monitoring, an mHealth app, nurse-led lifestyle counselling and treatment with a simplified hypertension control protocol.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+