Addressing Hypertension Care in Africa

Study Overview
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Brief Summary
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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

Detailed Description
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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 The intervention will be administered for six months following which it will be withdrawn, and patients will be followed for six more months to assess outcomes.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 oversample 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.

Official Title
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Addressing Hypertension Control in Africa (ADHINCRA) Study

Conditions
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Hypertension, Diabetes, Telemedicine

Intervention / Treatment
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* Behavioral: Enhanced Usual Care Group
* Other: Usual Care Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Usual Care Group<br>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<br>* 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: Reminders Participant to CHO messaging Home BP tracking 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. CHO provider portal- The provider portal will include decision support tools.<br>|
| Active Comparator: Usual Care<br>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<br>* Regular/usual appointments or visits to patients' healthcare provider for management of study outcomes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin A1C between arms | 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 | 
| Difference in Hypertensive Urgencies and Emergencies between arms | 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 | 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 | 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 | 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 | 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 |