Addressing Hypertension Care in Africa (ADHINCRA)

February 22, 2024 updated by: Johns Hopkins University

Addressing Hypertension Control in Africa (ADHINCRA) Study

A pilot cluster randomized control trial to test the feasibility of a multilevel, nurse-led, mobile health enhanced intervention in patients with uncontrolled hypertension in Ghana

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a two-arm pilot cluster randomized controlled trial (RCT) involving 240 participants with uncontrolled hypertension (HTN) with the healthcare setting as the unit of randomization and patients as the unit of analysis. Each of the four healthcare settings will be recruited and randomly assigned to the multilevel intervention or control group. A statistician will generate the randomization using a computer-generated random sequence program with an allocation ratio of 1:1 and a block size of 6 (to assure equal numbers in each arm). After having met study criteria for enrollment, 60 eligible patients for each setting will be assigned to either control or intervention arm according to the patients' healthcare setting's intervention assignment by the study coordinator. A cluster RCT has been chosen to avoid potential treatment contamination in which physicians within healthcare settings might unintentionally provide patients with different degrees of attention or blending of treatment protocols. The intervention will be administered for six months following which it will be withdrawn, and patients will be followed for six more months to assess outcomes.

The investigators will use quota sampling to over sample socioeconomically deprived persons to ensure that socioeconomically deprived persons comprise 50% of the sample. Poverty will be defined by (1) Household income, based on Ghana minimum monthly wage of 210 Ghana cedis (equivalent of $55). After screening eligible participants, the investigators will assign four clusters of 60 patients to the intervention or control arms. The investigators will require 30 patients in each cluster to be male and 30 to be female since in the investigators' previous work, men have been underrepresented potentially due to gender-differences in healthcare seeking behaviors. Men have also had inferior treatment and control rates in previous studies.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ghana
    • Ashanti Region
      • Kumasi, Ashanti Region, Ghana
        • Komfo Anokye Teaching Hospital
      • Kumasi, Ashanti Region, Ghana
        • Kumasi South Hospital
      • Kumasi, Ashanti Region, Ghana
        • Manhyia Government Hospital
      • Kumasi, Ashanti Region, Ghana
        • Suntreso Government Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients will be included if they are 18-70 years old;
  • Male or female
  • Uncontrolled hypertension (SBP ≥140 mm Hg) based upon last outpatient encounter within the previous three months
  • Patients with previous strokes, coronary artery disease, up to stage three kidney disease and diabetes mellitus meeting BP cut-off criteria will be eligible for enrollment.

Exclusion Criteria:

  • Patients will be excluded if they fail to meet any of the above inclusion criteria
  • Severe cognitive impairment/dementia (Modified Mini-Mental State Examination (MMSE) score ≤24)
  • Severe global disability (modified Rankin Scale (mRS) score ≥3)
  • Not able to independently follow blood pressure measurement protocol or use of Smartphone for study protocol or without a care-giver to assist with BP monitoring at home
  • Patients with estimated glomerular filtration rate (eGFR) <30ml/min

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced Usual Care Group
All participants in the enhanced usual care arm must own a cell phone with at least short message service (SMS) and voicemail. To control for attention exposure, they will receive SMS messages daily dealing with healthy lifestyle behaviors (smoking, diet, physical activity) but not with medication adherence or hypertension-specific issues. Every three days (comparable to intervention group monitoring) they will receive an automated SMS directing them to a different 2-3 min video/YouTube™ clips on healthy lifestyles. Patients in this arm of the study will also receive usual care as determined by their providers. Usual care is described in the next section.
Behavioral: Enhanced Usual Care Group

Medtronic® Labs' Akoma pa app, a culturally-tested and locally attuned mobile health platform, will be used in the intervention arm of the study to improve communication between the Community Health Officer (CHO) and the participant. This platform will be used to enhance shared decision making, clinical decision support, participatory communication, knowledge, treatment adherence (medication and lifestyle modification), and self-monitoring of hypertension. We will test the feasibility of the Akoma pa app in addressing patient-level and provider-level barriers to hypertension control.

The app will consist of the following components:

  1. Reminders
  2. Participant to CHO messaging
  3. Home BP tracking
  4. Educational materials on cardiovascular disease (CVD) and Stroke- Participants will have access to education modules on reducing the risk of CVD and stroke tailored to their knowledge level.
  5. CHO provider portal- The provider portal will include decision support tools.
Active Comparator: Usual Care
Patients in this arm of the study will receive usual care as determined by their providers. Usual care in the region typically involves at least one visit every 2-3 months for review of adherence to treatment, blood pressure control, and prescriptions for medication refills. Similar to the intervention group, participants will have a total of three follow-up visits which will be separate from their regular appointments during which study outcomes will be assessed.
Other: Usual Care Group
Regular/usual appointments or visits to patients' healthcare provider for management of study outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Blood Pressure levels from Baseline
Time Frame: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months
Changes in Blood pressure levels, measured in mmHg, will be assessed at the baseline, 1-month, 3-month, 6-month, 9-month, and 12-month visits.
Baseline, 1 month , 3 months, 6 months, 9 months, 12 months
Change in Blood Pressure control by poverty status from Baseline
Time Frame: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months
Blood pressure control - defined as systolic blood pressure (SBP) < 140 mm Hg SBP reduction will be compared by deprivation status defined by monthly income < 210 Ghana cedis determined at the enrollment visit.
Baseline, 1 month , 3 months, 6 months, 9 months, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Hypertensive Urgencies and Emergencies between arms
Time Frame: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months
Difference in the number of emergency room visits (for hypertensive urgencies and/or emergencies) for both arms will be examined at the 1-month, 3-month, 6-month, 9-month, and 12-month visits. after the initial baseline assessment.
Baseline, 1 month , 3 months, 6 months, 9 months, 12 months
Difference in Cardiovascular Disease (CVD) Events between study arms
Time Frame: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months
Difference in the number of CVD events (such as strokes, coronary artery disease, heart failures, and deaths) for both arms will be examined at the 1-month, 3-month, 6-month, 9-month, and 12-month visits after the initial baseline assessment.
Baseline, 1 month , 3 months, 6 months, 9 months, 12 months
Difference in treatment adherence as assessed by the Hill-Bone Medication Adherence Scale
Time Frame: At 6 months
Self-Reported Medication Adherence will be assessed with the 9-item Hill-Bone Medication Adherence Scale and compared in both arms at months 6 and 12 by poverty status. The Hill-Bone has broad applicability in measuring medication adherence in patients with hypertension, diabetes, chronic obstructive pulmonary disease, stroke among others. Scores range from 9 - 36 with higher scores indicating poorer adherence to antihypertensive drug therapy.
At 6 months
Difference in treatment adherence as assessed by the Hill-Bone Medication Adherence Scale
Time Frame: At 12 months
Self-Reported Medication Adherence will be assessed with the 9-item Hill-Bone Medication Adherence Scale and compared in both arms at months 6 and 12 by poverty status. The Hill-Bone has broad applicability in measuring medication adherence in patients with hypertension, diabetes, chronic obstructive pulmonary disease, stroke among others. Scores range from 9 - 36 with higher scores indicating poorer adherence to antihypertensive drug therapy.
At 12 months
Change in the acceptability and usability of the Akoma pa app score as assessed by the Marshfield System Usability Survey
Time Frame: At 1 month , 3 months, 6 months, 9 months, 12 months
The acceptability and usability of the Akoma pa app will be assessed with the 16-item Marshfield System Usability Survey. Scores on this instrument range from 16 to 80 with higher scores indicating better usability. This will be examined at the 1-month, 3-month, 6-month, 9-month, and 12-month visits after the initial baseline assessment.
At 1 month , 3 months, 6 months, 9 months, 12 months
Change in glycohemoglobin (A1C) between arms
Time Frame: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months
Hgb A1C in both study arms will be examined for change at the 1-month, 3-month, 6-month, 9-month, and 12-month visits after the initial baseline assessment.
Baseline, 1 month , 3 months, 6 months, 9 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Johns Hopkins Alliance for a Healthier World

Investigators

  • Principal Investigator: Yvonne Commodore-Mensah, PhD, MHS, RN, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2019

Primary Completion (Actual)

May 3, 2021

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

July 3, 2019

First Submitted That Met QC Criteria

July 3, 2019

First Posted (Actual)

July 8, 2019

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00218586

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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