Addressing Hypertension Care in Africa Program (ADHINCRA)

Johns Hopkins University

Status: Enrolling

Conditions: Hypertension; High Blood Pressure

Treatments: Behavioral: ADHINCRA Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06986590

1R01HL175642-01 (U.S. NIH Grant/Contract)

IRB00504718

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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800 participants in 4 patient groups

Cohort 1

Experimental group

Description:

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.

Treatment:

Behavioral: ADHINCRA Program

Cohort 2

Experimental group

Description:

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

Treatment:

Behavioral: ADHINCRA Program

Cohort 3

Experimental group

Description:

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

Treatment:

Behavioral: ADHINCRA Program

Cohort 4

Experimental group

Description:

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

Treatment:

Behavioral: ADHINCRA Program