ADHINCRA Program for High Blood Pressure

(ADHINCRA Trial)

Not yet recruiting at 17 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a program designed to help individuals manage high blood pressure by examining factors such as patient habits and healthcare practices. Participants will use tools like home blood pressure monitors, a mobile health app, and receive lifestyle advice from nurses. The goal is to develop a model for improved hypertension management in Africa, potentially reducing the risks of heart disease, stroke, and kidney problems. Individuals with high blood pressure (but not diabetes) who own a smartphone may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance hypertension care across Africa.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the ADHINCRA Program is safe for controlling hypertension?

Research has shown that the ADHINCRA Program, which helps improve blood pressure control, uses a combination of proven methods. These include home blood pressure monitoring, a mobile health app, nurse advice on healthy lifestyle choices, and a simple plan to manage high blood pressure.

No specific data on safety issues or side effects exists for this program. However, because it focuses on lifestyle changes and monitoring rather than new medications, the risks are likely very low. It employs methods already known to be safe and effective for managing high blood pressure. For those considering joining the trial, this type of program is generally easy to follow. Participants should always consult the trial team with any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ADHINCRA Program for high blood pressure because it's taking a fresh approach compared to traditional treatments like medication alone. This program combines home blood pressure monitoring with a mHealth app, offering real-time tracking and feedback. Additionally, it includes nurse-led lifestyle counseling, which can provide personalized support and potentially enhance adherence to healthier habits. By integrating these elements with a simplified hypertension control protocol, the program aims to offer a more comprehensive and supportive way to manage high blood pressure, which could lead to better outcomes than medication alone.

What evidence suggests that the ADHINCRA Program is effective for high blood pressure?

Research has shown that the ADHINCRA Program is designed to help manage high blood pressure in Africa. The program combines home blood pressure checks, a mobile health app, nurse-led lifestyle advice, and a simple treatment plan. These methods have successfully helped participants control their blood pressure. By focusing on patients, healthcare providers, and the health system, the program aims to lower the risk of heart disease, stroke, and kidney disease. Another study found that similar programs improved blood pressure control and lowered systolic blood pressure in participants. This suggests that the ADHINCRA Program could effectively manage high blood pressure. ^{1 2 3 4 6}

Who Is on the Research Team?

Yvonne Commodore-Mensah, PhD, MHS, RN

Principal Investigator

Johns Hopkins University

Fred S Sarfo, MBBS, PhD, FWACP

Principal Investigator

Kwame Nkrumah University of Science and Technology

Dike B Ojji, MBBS, PhD, FWACP

Principal Investigator

University of Abuja

Are You a Good Fit for This Trial?

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

Owns a smartphone (Android or iOS)

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. publichealth.jhu.edu publichealth.jhu.edu/center-for-health-equity/what-we-do/research/current-projects/adhincra-addressing-hypertension-care-in-africa-2018-2021

ADHINCRA (Addressing Hypertension Care in Africa) (2018 The Center for Health Equity's (CHE) “Addressing Hypertension Care in Africa” (ADHINCRA) study focuses on techniques to manage high blood pressure in western ...

2. reporter.nih.gov reporter.nih.gov/project-details/11192363

The ADHINCRA Study: Addressing HypertensIoN Care in ... Project Summary/Abstract Innovation in chronic disease management is urgently needed to effectively control hypertension (HTN) in Ghana and Nigeria.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06986590

NCT06986590 | Addressing Hypertension Care in Africa ... The ADHINCRA Program is a bundle of multilevel evidence-based interventions that address multiple predictors of controlled hypertension, including patient-, ...

4. ahajournals.org ahajournals.org/doi/10.1161/circ.148.suppl_1.15333

The Addressing Hypertension Care in Africa (ADHINCRA ... The enhanced UC arm received usual care, plus short text messages on health. The primary outcome was change in BP control status at 6 and 12 ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422004037

Study protocol for a cluster-randomized controlled pilot trial Clinical outcomes included changes in BP control status and systolic BP levels from baseline. Secondary outcomes included change in glycemic control, rates of ...

6. annalsofglobalhealth.org annalsofglobalhealth.org/articles/10.5334/aogh.4246

Healthcare system barriers and facilitators to hypertension ... Conclusion: Our findings highlight critical barriers to hypertension service delivery and providers' abilities to provide quality services.