Addressing Hypertension Care in Africa

NCT04010344 | Completed

• 1 other identifier: IRB00218586
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Hypertension; Diabetes; Telemedicine

Outcome Measures

Primary Outcomes (2)

• Change in Blood Pressure levels from Baseline

  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

  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 Outcomes (6)

• Change in glycohemoglobin (A1C) between arms

  Baseline, 1 month , 3 months, 6 months, 9 months, 12 months

• Difference in Hypertensive Urgencies and Emergencies between arms

  Baseline, 1 month , 3 months, 6 months, 9 months, 12 months

• Difference in Cardiovascular Disease (CVD) Events between study arms

  Baseline, 1 month , 3 months, 6 months, 9 months, 12 months

• Difference in treatment adherence as assessed by the Hill-Bone Medication Adherence Scale

  At 6 months

• Difference in treatment adherence as assessed by the Hill-Bone Medication Adherence Scale

  At 12 months

Study Arms (2)

Enhanced Usual Care Group

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

Enhanced Usual Care Group BEHAVIORAL

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.

Enhanced Usual Care Group

Usual Care Group OTHER

Regular/usual appointments or visits to patients' healthcare provider for management of study outcomes

Usual Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Johns Hopkins Alliance for a Healthier World: collaborator

Study Sites (4)

Komfo Anokye Teaching Hospital

Kumasi, Ashanti Region, Ghana

Location

Kumasi South Hospital

Kumasi, Ashanti Region, Ghana

Location

Manhyia Government Hospital

Kumasi, Ashanti Region, Ghana

Location

Suntreso Government Hospital

Kumasi, Ashanti Region, Ghana

Location

Related Publications (18)

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• Sarfo FS, Ovbiagele B, Gebregziabher M, Wahab K, Akinyemi R, Akpalu A, Akpa O, Obiako R, Owolabi L, Jenkins C, Owolabi M; SIREN. Stroke Among Young West Africans: Evidence From the SIREN (Stroke Investigative Research and Educational Network) Large Multisite Case-Control Study. Stroke. 2018 May;49(5):1116-1122. doi: 10.1161/STROKEAHA.118.020783. Epub 2018 Apr 4.

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  PMID: 36592818 DERIVED

Related Links

• World Health Organization(WHO). Chapter XIII: Hypertension in adherence to LongTerm therapies-evidence for action.
• World Health Statistics

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Yvonne Commodore-Mensah, PhD, MHS, RN

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Other staff will conduct the evaluations using established protocols. They will remain blinded as to patients' group status throughout the study (i.e., pre-intervention, 1, 3, 6 \& 9-month evaluations).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm pilot cluster randomized control trial involving 240 participants with uncontrolled hypertension. The healthcare setting is the unit of randomization and patients are the unit of analysis. Each of the four healthcare settings will be recruited and randomly assigned to the multilevel intervention or control group. Randomization will be performed using a computer-generated random sequence program with a 1:1 allocation and a block size of 6 (to assure equal numbers in each arm). After meeting the study criteria for enrollment, 60 eligible patients for each setting will be assigned to either control or intervention arm according to their healthcare setting's intervention assignment by the study coordinator. 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.

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 8, 2019
• Study Start: July 14, 2019
• Primary Completion: May 3, 2021
• Study Completion: December 30, 2024
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GH (4)