Trial Outcomes & Findings for Impact of Community Health Workers on Adherence to Therapy for Non-Communicable Chronic Disease in Chiapas, Mexico (NCT NCT02549495)
NCT ID: NCT02549495
Last Updated: 2025-12-22
Results Overview
Change in percent glycated hemoglobin as measured by PTS diagnostics point-of-care assay
COMPLETED
168 participants
Baseline, 23 months
2025-12-22
Participant Flow
Patients with diabetes, hypertension and respective risk factors were identified via a CES programme of clinic-based and door-to-door case finding.
Patients were excluded from participation after enrollment but prior to start of study if they were taken off treatment, we not actually on treatment, were enrolled after baseline data collection, moved outside study area, sought care in a different health system, or were found not to have diabetes and/or hypertension.
Participant milestones
| Measure |
Patients With Diabetes or Hypertension
All patients in the seven study communities will receive the community health worker intervention provided by CES, as it is incorporated into the standard of care. However, they will receive the intervention at different points in time depending on which community they lived in, as community health worker programs can only be started at every-three-month intervals. Due to the stepped programmatic roll-out, the study mimics a stepped wedge cluster-randomized trial.
|
|---|---|
|
Overall Study
STARTED
|
168
|
|
Overall Study
COMPLETED
|
127
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
Patients With Diabetes or Hypertension
All patients in the seven study communities will receive the community health worker intervention provided by CES, as it is incorporated into the standard of care. However, they will receive the intervention at different points in time depending on which community they lived in, as community health worker programs can only be started at every-three-month intervals. Due to the stepped programmatic roll-out, the study mimics a stepped wedge cluster-randomized trial.
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Physician Decision
|
22
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Protocol Violation
|
6
|
Baseline Characteristics
Impact of Community Health Workers on Adherence to Therapy for Non-Communicable Chronic Disease in Chiapas, Mexico
Baseline characteristics by cohort
| Measure |
Patients With Diabetes or Hypertension
n=149 Participants
All patients in the seven study communities will receive the community health worker intervention provided by CES, as it is incorporated into the standard of care. However, they will receive the intervention at different points in time depending on which community they lived in, as community health worker programs can only be started at every-three-month intervals.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
107 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
42 Participants
n=18 Participants
|
|
Age, Continuous
|
58 years
n=18 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
149 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
|
Region of Enrollment
Mexico
|
149 participants
n=18 Participants
|
|
Has a radio
|
93 Participants
n=18 Participants
|
|
Has a car/motorcycle
|
43 Participants
n=18 Participants
|
|
Type of remuneration
Salary
|
8 Participants
n=18 Participants
|
|
Type of remuneration
Day labour
|
58 Participants
n=18 Participants
|
|
Type of remuneration
None
|
83 Participants
n=18 Participants
|
|
Diabetes diagnosis
|
70 Participants
n=18 Participants
|
|
Hypertension diagnosis
|
110 Participants
n=18 Participants
|
|
Systolic Blood Pressure
|
135 mm Hg
n=18 Participants
|
|
HbA1c
|
9.3 percent of glycosylated hemoglobin
n=18 Participants
|
PRIMARY outcome
Timeframe: Baseline, 23 monthsChange in percent glycated hemoglobin as measured by PTS diagnostics point-of-care assay
Outcome measures
| Measure |
Patients With Diabetes
n=73 Participants
Patients with diabetes included in the study
|
|---|---|
|
Change in Hemoglobin A1c
|
-0.35 percentage of glycated hemoglobin
Interval -0.9 to 0.2
|
PRIMARY outcome
Timeframe: Baseline, 23 monthsChange in Systolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure monitor
Outcome measures
| Measure |
Patients With Diabetes
n=117 Participants
Patients with diabetes included in the study
|
|---|---|
|
Change in Systolic Blood Pressure
|
-4.7 mmHg
Interval -8.9 to -0.6
|
SECONDARY outcome
Timeframe: One year after all communities receive interventionPopulation: Data were not collected for this measure and the outcome cannot be reported
Change in self-reported medication adherence as measured by 5-day recall, 30-day recall and response to Likert-style questions
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 23 monthsChange in diastolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure
Outcome measures
| Measure |
Patients With Diabetes
n=117 Participants
Patients with diabetes included in the study
|
|---|---|
|
Change in Diastolic Blood Pressure
|
-2.2 mmHg
Interval -4.5 to 0.1
|
SECONDARY outcome
Timeframe: One year after all communities receive interventionPopulation: Data were not collected and the outcome cannot be reported
Diabetes and/or hypertension control. Disease control among patients with hypertension was defined according to Mexican national guidelines: blood pressure \<140/90 mm Hg for patients with hypertension and no diabetes; blood pressure \<130/80 mm Hg for patients with hypertension and diabetes and blood pressure \< 150/90 mm Hg for patients over the age of 80. Disease control for patients with diabetes defined as glycated hemoglobin (HbA1c) \< 7% per national guidelines.
Outcome measures
Outcome data not reported
Adverse Events
Standard of Care
CHW Intervention
Serious adverse events
| Measure |
Standard of Care
n=149 participants at risk
Patients with hypertension and/or diabetes across seven study communities prior to CHW intervention.
|
CHW Intervention
n=149 participants at risk
Patients with hypertension and/or diabetes across seven study communities following CHW intervention.
|
|---|---|---|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/149 • Through study completion, an average of 2 years
Study staff regularly monitored participants and kept an adverse event log that was reported to the IRB. Clinical events monitored include death, myocardial infarction, and stroke.
|
0.67%
1/149 • Number of events 1 • Through study completion, an average of 2 years
Study staff regularly monitored participants and kept an adverse event log that was reported to the IRB. Clinical events monitored include death, myocardial infarction, and stroke.
|
|
Nervous system disorders
Stroke
|
0.00%
0/149 • Through study completion, an average of 2 years
Study staff regularly monitored participants and kept an adverse event log that was reported to the IRB. Clinical events monitored include death, myocardial infarction, and stroke.
|
0.00%
0/149 • Through study completion, an average of 2 years
Study staff regularly monitored participants and kept an adverse event log that was reported to the IRB. Clinical events monitored include death, myocardial infarction, and stroke.
|
Other adverse events
Adverse event data not reported
Additional Information
Daniel Palazuelos, MD, MPH
Brigham and Women's Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place