Clinical trial NCT04010344: Addressing Hypertension Care in Africa
Official title: Addressing Hypertension Control in Africa (ADHINCRA) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Diabetes
Telemedicine
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Johns Hopkins Alliance for a Healthier World
First posted: 2019-07-08
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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 The intervention will be administered for six months following which it will be withdrawn, and patients will be followed for six more months to assess outcomes.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Blood Pressure levels from Baseline
timeFrame: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months
measure: Change in Blood Pressure control by poverty status from Baseline
timeFrame: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months
Secondary outcomes:
measure: Change in glycohemoglobin (A1C) between arms
timeFrame: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months
measure: Difference in Hypertensive Urgencies and Emergencies between arms
timeFrame: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months
measure: Difference in Cardiovascular Disease (CVD) Events between study arms
timeFrame: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months
measure: Difference in treatment adherence as assessed by the Hill-Bone Medication Adherence Scale
timeFrame: At 6 months
measure: Difference in treatment adherence as assessed by the Hill-Bone Medication Adherence Scale
timeFrame: At 12 months
measure: Change in the acceptability and usability of the Akoma pa app score as assessed by the Marshfield System Usability Survey
timeFrame: At 1 month , 3 months, 6 months, 9 months, 12 months
Other outcomes:
Locations:
city: Kumasi
country: Ghana
facility: Komfo Anokye Teaching Hospital
state: Ashanti Region
city: Kumasi
country: Ghana
facility: Kumasi South Hospital
state: Ashanti Region
city: Kumasi
country: Ghana
facility: Manhyia Government Hospital
state: Ashanti Region
city: Kumasi
country: Ghana
facility: Suntreso Government Hospital
state: Ashanti Region
Study officials:
affiliation: Johns Hopkins University
name: Yvonne Commodore-Mensah, PhD, MHS, RN
role: PRINCIPAL_INVESTIGATOR
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