Trial Outcomes & Findings for Implementation of a Combination Intervention for Sustainable Blood Pressure Control (NCT NCT05492955)
NCT ID: NCT05492955
Last Updated: 2026-03-12
Results Overview
Absolute change in systolic blood pressure (SBP) between baseline and 6 months after enrollment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
774 participants
Primary outcome timeframe
6 months
Results posted on
2026-03-12
Participant Flow
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.
Participant milestones
| Measure |
Standard of Care (SOC)
Participants will receive clinic-based standard of care
Standard 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.
|
Community Health Worker Care Model (CHW)
Participants will be given a standard blood pressure cuff (Omron) for at-home BP monitoring, and will be assigned to a CHW for follow-up visits and medication delivery.
Community 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.
|
Enhanced Community Health Worker + Mobile Health Monitoring (eCHW+)
Participants will be given a blood pressure cuff with cellular capability (Blipcare) for at-home BP monitoring which automatically transmit BP data to our server for nurse review. These participants will also be assigned to a CHW for follow-up visits and medication delivery.
Enhanced 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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
259
|
257
|
258
|
|
Overall Study
COMPLETED
|
255
|
251
|
256
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
2
|
Reasons for withdrawal
| Measure |
Standard of Care (SOC)
Participants will receive clinic-based standard of care
Standard 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.
|
Community Health Worker Care Model (CHW)
Participants will be given a standard blood pressure cuff (Omron) for at-home BP monitoring, and will be assigned to a CHW for follow-up visits and medication delivery.
Community 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.
|
Enhanced Community Health Worker + Mobile Health Monitoring (eCHW+)
Participants will be given a blood pressure cuff with cellular capability (Blipcare) for at-home BP monitoring which automatically transmit BP data to our server for nurse review. These participants will also be assigned to a CHW for follow-up visits and medication delivery.
Enhanced 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.
|
|---|---|---|---|
|
Overall Study
Death
|
3
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
1
|
Baseline Characteristics
Implementation of a Combination Intervention for Sustainable Blood Pressure Control
Baseline characteristics by cohort
| Measure |
Standard of Care (SOC)
n=259 Participants
Participants will receive clinic-based standard of care
Standard 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.
|
Community Health Worker Care Model (CHW)
n=257 Participants
Participants will be given a standard blood pressure cuff (Omron) for at-home BP monitoring, and will be assigned to a CHW for follow-up visits and medication delivery.
Community 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.
|
Enhanced Community Health Worker + Mobile Health Monitoring (eCHW+)
n=258 Participants
Participants will be given a blood pressure cuff with cellular capability (Blipcare) for at-home BP monitoring which automatically transmit BP data to our server for nurse review. These participants will also be assigned to a CHW for follow-up visits and medication delivery.
Enhanced 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.
|
Total
n=774 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
152 Participants
n=9 Participants
|
147 Participants
n=9 Participants
|
147 Participants
n=18 Participants
|
446 Participants
n=15 Participants
|
|
Age, Categorical
>=65 years
|
107 Participants
n=9 Participants
|
110 Participants
n=9 Participants
|
111 Participants
n=18 Participants
|
328 Participants
n=15 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 12 • n=9 Participants
|
62 years
STANDARD_DEVIATION 11 • n=9 Participants
|
62 years
STANDARD_DEVIATION 12 • n=18 Participants
|
62 years
STANDARD_DEVIATION 12 • n=15 Participants
|
|
Sex: Female, Male
Female
|
194 Participants
n=9 Participants
|
202 Participants
n=9 Participants
|
192 Participants
n=18 Participants
|
588 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=9 Participants
|
55 Participants
n=9 Participants
|
66 Participants
n=18 Participants
|
186 Participants
n=15 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Black or African American
|
259 Participants
n=9 Participants
|
257 Participants
n=9 Participants
|
258 Participants
n=18 Participants
|
774 Participants
n=15 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
|
Region of Enrollment
South Africa
|
259 Participants
n=9 Participants
|
257 Participants
n=9 Participants
|
258 Participants
n=18 Participants
|
774 Participants
n=15 Participants
|
|
Systolic Blood Pressure
|
147.4 mmHg
STANDARD_DEVIATION 16.4 • n=9 Participants
|
146.6 mmHg
STANDARD_DEVIATION 18.0 • n=9 Participants
|
146.8 mmHg
STANDARD_DEVIATION 17.2 • n=18 Participants
|
147.0 mmHg
STANDARD_DEVIATION 17.2 • n=15 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: In the SOC arm, 3 participants had died and 1 participant had disenrolled at 6 months, the time point for assessing the primary outcome. Similarly, in the CHW arm, 1 person died and 5 disenrolled, while 1 person died and 1 disenrolled in the eCHW+ arm.
Absolute change in systolic blood pressure (SBP) between baseline and 6 months after enrollment.
Outcome measures
| Measure |
Standard of Care (SOC)
n=255 Participants
Participants will receive clinic-based standard of care
Standard 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.
|
Community Health Worker Care Model (CHW)
n=251 Participants
Participants will be given a standard blood pressure cuff (Omron) for at-home BP monitoring, and will be assigned to a CHW for follow-up visits and medication delivery.
Community 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.
|
Enhanced Community Health Worker + Mobile Health Monitoring (eCHW+)
n=256 Participants
Participants will be given a blood pressure cuff with cellular capability (Blipcare) for at-home BP monitoring which automatically transmit BP data to our server for nurse review. These participants will also be assigned to a CHW for follow-up visits and medication delivery.
Enhanced 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.
|
|---|---|---|---|
|
Mean Systolic Blood Pressure (SBP) Change
|
-1.9 mmHg
Interval -4.2 to 0.4
|
-9.1 mmHg
Interval -11.3 to -6.8
|
-10.5 mmHg
Interval -12.8 to -8.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: In the SOC arm, 3 participants had died and 1 participant had disenrolled at 6 months, the time point for assessing the primary outcome. Similarly, in the CHW arm, 1 person died and 5 disenrolled, while 1 person died and 1 disenrolled in the eCHW+ arm.
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.
Outcome measures
| Measure |
Standard of Care (SOC)
n=255 Participants
Participants will receive clinic-based standard of care
Standard 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.
|
Community Health Worker Care Model (CHW)
n=251 Participants
Participants will be given a standard blood pressure cuff (Omron) for at-home BP monitoring, and will be assigned to a CHW for follow-up visits and medication delivery.
Community 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.
|
Enhanced Community Health Worker + Mobile Health Monitoring (eCHW+)
n=256 Participants
Participants will be given a blood pressure cuff with cellular capability (Blipcare) for at-home BP monitoring which automatically transmit BP data to our server for nurse review. These participants will also be assigned to a CHW for follow-up visits and medication delivery.
Enhanced 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.
|
|---|---|---|---|
|
Percentage of Participants With Blood Pressure Control (%)
|
32.5 Percentage of participants
Interval 27.1 to 38.6
|
57.4 Percentage of participants
Interval 51.1 to 63.4
|
61.3 Percentage of participants
Interval 55.2 to 67.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: In the SOC arm, 3 participants had died and 1 participant had disenrolled at 6 months, the time point for assessing the primary outcome. Similarly, in the CHW arm, 1 person died and 5 disenrolled, while 1 person died and 1 disenrolled in the eCHW+ arm.
Number of participants who experienced adverse and severe adverse events, in each of the three study arms.
Outcome measures
| Measure |
Standard of Care (SOC)
n=255 Participants
Participants will receive clinic-based standard of care
Standard 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.
|
Community Health Worker Care Model (CHW)
n=251 Participants
Participants will be given a standard blood pressure cuff (Omron) for at-home BP monitoring, and will be assigned to a CHW for follow-up visits and medication delivery.
Community 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.
|
Enhanced Community Health Worker + Mobile Health Monitoring (eCHW+)
n=256 Participants
Participants will be given a blood pressure cuff with cellular capability (Blipcare) for at-home BP monitoring which automatically transmit BP data to our server for nurse review. These participants will also be assigned to a CHW for follow-up visits and medication delivery.
Enhanced 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.
|
|---|---|---|---|
|
Number of Participants Who Experienced Adverse Events (Safety)
|
4 Participants
|
7 Participants
|
10 Participants
|
Adverse Events
Standard of Care (SOC)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 3 deaths
Community Health Worker Care Model (CHW)
Serious events: 6 serious events
Other events: 0 other events
Deaths: 1 deaths
Enhanced Community Health Worker + Mobile Health Monitoring (eCHW+)
Serious events: 6 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Standard of Care (SOC)
n=259 participants at risk
Participants will receive clinic-based standard of care
Standard 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.
|
Community Health Worker Care Model (CHW)
n=257 participants at risk
Participants will be given a standard blood pressure cuff (Omron) for at-home BP monitoring, and will be assigned to a CHW for follow-up visits and medication delivery.
Community 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.
|
Enhanced Community Health Worker + Mobile Health Monitoring (eCHW+)
n=258 participants at risk
Participants will be given a blood pressure cuff with cellular capability (Blipcare) for at-home BP monitoring which automatically transmit BP data to our server for nurse review. These participants will also be assigned to a CHW for follow-up visits and medication delivery.
Enhanced 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.
|
|---|---|---|---|
|
General disorders
Hospitalization
|
0.39%
1/259 • Number of events 4 • Six months
|
2.3%
6/257 • Number of events 7 • Six months
|
2.3%
6/258 • Number of events 10 • Six months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place