This is a randomized clinical trial intended to identify the optimal strategy of blood pressure management in rural South Africa using Community Health Workers (CHWs) in conjunction with in-home BP monitoring among adults.
We will conduct a trial using CHWs in conjunction with in-home BP monitoring among 774 adults ≥ 18 years old residing in uMkhanyakude District in northern KwaZulu-Natal in an area that is served by a CHW. Eligible participants will be recruited from prior community-based hypertension screening programs, CHW-led hypertension screening activities, and/or from trial clinics where they are accessing care. Consenting participants will be randomized to one of the three study arms of hypertension care (258 participants per arm): 1) clinic-based standard of care model (SOC); 2) community health worker-based blood pressure monitoring model (CHW); 3) and enhanced community health worker-based model, including mobile health blood pressure monitoring model (eCHW+). Independent of clinical care, all participants will be seen at enrollment and at 6 months for BP monitoring and data collection by study nurses for outcome assessments. The primary effectiveness outcome will be assessed in an intention-to-treat analysis and defined as the change in systolic blood pressure (SBP) 6 months after enrollment. The secondary effectiveness outcome will be the proportion of participants with controlled blood pressure, as defined by an SBP \<140 mmHg and a diastolic BP (DBP) \<90 mmHg 6 months after enrollment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
774
Participants will be given a digital BP Cuff and a standardized training on its operation, and assigned a CHW from their local Community Health Team. The participant will be instructed to take 6-10 measurements BP per week and record them in a logbook. CHWs will return to participant homes every 2-4 weeks to collect BP measurements and enter them into a data collection system, assess for symptoms, and discuss treatment adherence and lifestyle recommendations. BP readings will be brought by the CHW to their assigned nursing supervisors at their local clinic, who will initiate and tailor medications based on a standardized clinical decision support algorithm, based on SA DoH hypertension control guidelines. All treatment decisions will be made by the nursing supervisors. Participants will either obtain medication(s) at the pharmacy or, as possible, have them delivered by a CHW.
Participants in this arm will also be given a BP Cuff, (but with cellular network capability, such that BP data can be directly transmitted to trial server), given training on its operation, and assigned a CHW from their local Community Health Team. The participant will be instructed to take 6-10 measurements BP per week, which will be automatically uploaded onto the server to be made available by the nurse supervisors. CHWs will return to participant homes every 2-4 weeks to ensure functionality of the devices and transmission, collect BP measurements if the system is not functional, assess for symptoms, and discuss treatment adherence and lifestyle recommendations. Nursing supervisors at the clinic will use the remotely collected BP data to initiate and tailor medications based on the same standardized clinical decision support (CDS) algorithm, based on SA DoH hypertension control guidelines. All treatment decisions will be made by the nursing supervisors.
Africa Health Research Institute (AHRI)
Mtubatuba, KwaZulu-Natal, South Africa
Mean Systolic Blood Pressure (SBP) Change
Absolute change in systolic blood pressure (SBP) between baseline and 6 months after enrollment.
Time frame: 6 months
Percentage of Participants With Blood Pressure Control (%)
Percentage of participants in each of the three study arms who had achieved blood pressure (BP) control. BP control is defined the percentage of participants who have a measured BPe \<140/90 mmHg, among the total number of participants, in each respective study arm, as measured at 6 months after enrollment. The percentages reported are model-based estimated probabilities rather than raw observed proportions, and estimated using logistic regression, adjusted for the randomisation strata and baseline antihypertensive medication use. Arm-specific probabilities were obtained using marginal standardisation, yielding predicted probabilities from the fitted model, averaged over the covariate distribution of the analysis population, rather than counts divided by the number of participants arm. Estimates are thus continuous quantities not constrained to correspond exactly to whole numbers (e.g., 0.768 × 257 ≈ 197.4 participants), which is expected and statistically appropriate.
Time frame: 6 months
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Participants in the SOC arm will be referred to their clinic for active care as per standard clinical protocols. All care will be provided at the clinic. Routine care consists of regular visits to the clinic until BP is under control (\<140/90 mmHg) and then at 6 monthly intervals. BP measurements to guide management decisions will be made at the clinic using standard clinic equipment. Symptoms related to hypertension and/or medications will be assessed at each visit. Medications available will include medications on the South African Essential Drug list and which are available in the pharmacy. Prescriptions are picked up at the clinic pharmacy by patients as per routine protocol at the clinics. CHWs may also conduct monitoring as guided by clinical guidelines and as advised by their clinical supervisors during the study period to assess for adherence and provide education.