Hypertension
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCommunity Health Worker Care Model
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.
BEHAVIORALEnhanced Community Health Worker-based with Mobile Health Blood Pressure Monitoring Model
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.
BEHAVIORALStandard of Care Model
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.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than 18 years old * Residing in uMkhanyakude District in northern KwaZulu-Natal in an area that is served by a CHW. * Elevated blood pressure (blood pressure \> 140/90 mmHg) on two measurements.
Exclusion criteria
* Pregnant or breast-feeding women. * Severe, symptomatic hypertension with a measured blood pressure \> 180/110 mmHg. * Known, advanced chronic kidney disease. GFR \< 60 ml/min/1.73 m2. * Current use of at least 3 different anti-hypertensive therapies at full dose. * Planning to move within the next 24 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Systolic Blood Pressure (SBP) Change | 6 months | Absolute change in systolic blood pressure (SBP) between baseline and 6 months after enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Blood Pressure Control (%) | 6 months | 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. |
Countries
South Africa
Contacts
PRINCIPAL_INVESTIGATORThomas A Gaziano, MD, MSc
Massachusetts General Hospital
PRINCIPAL_INVESTIGATORMark J Siedner, MD, MPH
Massachusetts General Hospital
Participant flow
Recruitment details
From November 30, 2022, through June 25, 2024, a total of 910 patients with an elevated blood pressure and a record of at least one elevated reading 6 months earlier underwent screening at 2 primary health care clinics. Of these patients, 136 did not meet the eligibility criteria. The remaining 774 patients met eligibility criteria and provided written consent to participate in the trial.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 328 Participants |
| Age, Categorical Between 18 and 65 years | 446 Participants |
| Age, Continuous | 62 years STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 774 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment South Africa | 774 Participants |
| Sex: Female, Male Female | 194 Participants |
| Sex: Female, Male Male | 65 Participants |
| Systolic Blood Pressure | 146.6 mmHg STANDARD_DEVIATION 18 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 259 | 1 / 257 | 4 / 258 |
| other Total, other adverse events | 0 / 259 | 0 / 257 | 0 / 258 |
| serious Total, serious adverse events | 1 / 259 | 6 / 257 | 6 / 258 |
Outcome results
None listed