Addressing Hypertension Care in Africa (ADHINCRA)

Johns Hopkins University

Status: Completed

Conditions: Hypertension; Diabetes; Telemedicine

Treatments: Other: Usual Care Group; Behavioral: Enhanced Usual Care Group

Study type: Interventional

Funder types: Other

Identifiers

NCT04010344

IRB00218586

Details and patient eligibility

About

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

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 The intervention will be administered for six months following which it will be withdrawn, and patients will be followed for six more months to assess outcomes.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

Enrollment: 240 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

240 participants in 2 patient groups

Enhanced Usual Care Group

Experimental group

Description:

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.

Treatment:

Behavioral: Enhanced Usual Care Group

Usual Care

Active Comparator group

Description:

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.

Treatment:

Other: Usual Care Group