Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Harvard University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study evaluates the effectiveness of community health workers when added to routine care for patients with diabetes and high blood pressure in rural clinics in Chiapas, Mexico. It does so by recording information on adherence to therapy, blood pressure and hemoglobin A1c while a non-governmental organization working in Mexico trains and introduces a community health worker program.
Compañeros en Salud (CES), an affiliate project of Partners in Health, has been working in the rural Sierra of Chiapas, Mexico since February 2012. CES works in partnership with the local Ministry of Health to rehabilitate and staff existing government primary care clinics. Each community's clinic is staffed by one CES project physician year-round. CES activities span the range of allopathic medicine, but the focus of the project is in the prevention, detection, diagnosis and management of non-communicable diseases (NCDs) such as diabetes and hypertension. CES currently operates in several rural communities with catchment areas of approximately 1,500 - 2,500 people. Routine care for NCDs is based on national guidelines and consists of monthly in-clinic visits by primary care physicians.
Over 9 months in 2014 and again over 6 months in 2016, CES will introduce a community health worker program called "Acompañantes" to its project communities to augment care of patients with NCDs. Acompañantes are lay health workers and members of the community who bridge the gap between project clinics and patients, improving understanding of NCDs, their treatments, and adherence to therapy. The introduction of Acompañantes to communities is planned in a once-every-three-months fashion, the most rapid roll-out logistically feasible for CES. The investigators' project will document their experience over this time, and for one year after introduction of the Acompañantes program to all seven study communities, by documenting adherence to therapy, hemoglobin a1c, and blood pressure at every-three month intervals over this time frame.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c | Change in percent glycated hemoglobin as measured by PTS diagnostics point-of-care assay | Baseline, 23 months |
| Change in Systolic Blood Pressure | Change in Systolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure monitor | Baseline, 23 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Adherence to Daily Medications | Change in self-reported medication adherence as measured by 5-day recall, 30-day recall and response to Likert-style questions | One year after all communities receive intervention |
| Change in Diastolic Blood Pressure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult patients with Diabetes Mellitus, Type 2, or Hypertension, taking daily therapy, living in one of seven study communities in rural Chiapas, Mexico.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Patrick M Newman, MD | Brigham and Women's Hospital | Study Director |
| Daniel Palazuelos, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02130 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32152172 | Result | Worster DT, Franke MF, Bazua R, Flores H, Garcia Z, Krupp J, Maza J, Palazuelos L, Rodriguez K, Newman PM, Palazuelos D. Observational stepped-wedge analysis of a community health worker-led intervention for diabetes and hypertension in rural Mexico. BMJ Open. 2020 Mar 8;10(3):e034749. doi: 10.1136/bmjopen-2019-034749. | |
| 29527344 | Result |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Patients with diabetes, hypertension and respective risk factors were identified via a CES programme of clinic-based and door-to-door case finding.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Hemoglobin A1c | Change in percent glycated hemoglobin as measured by PTS diagnostics point-of-care assay | Posted | Median | 95% Confidence Interval | percentage of glycated hemoglobin | Baseline, 23 months |
|
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | Patients with hypertension and/or diabetes across seven study communities prior to CHW intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Artery Disease | Cardiac disorders | Systematic Assessment | Coronary artery disease would not be expected to result from standard of care or the intervention |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Palazuelos, MD, MPH | Brigham and Women's Hospital | 617-521-3381 | dpalazuelos@bwh.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2018 | Jun 15, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Change in diastolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure |
| Baseline, 23 months |
| Disease Control | 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. | One year after all communities receive intervention |
| Newman PM, Franke MF, Arrieta J, Carrasco H, Elliott P, Flores H, Friedman A, Graham S, Martinez L, Palazuelos L, Savage K, Tymeson H, Palazuelos D. Community health workers improve disease control and medication adherence among patients with diabetes and/or hypertension in Chiapas, Mexico: an observational stepped-wedge study. BMJ Glob Health. 2018 Feb 15;3(1):e000566. doi: 10.1136/bmjgh-2017-000566. eCollection 2018. |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Participants |
| No |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Has a radio | Count of Participants | Participants |
|
| Has a car/motorcycle | Count of Participants | Participants |
|
| Type of remuneration | Count of Participants | Participants |
|
| Diabetes diagnosis | Count of Participants | Participants |
|
| Hypertension diagnosis | Count of Participants | Participants |
|
| Systolic Blood Pressure | Median | Inter-Quartile Range | mm Hg |
|
| HbA1c | Median | Inter-Quartile Range | percent of glycosylated hemoglobin |
|
|
| Primary | Change in Systolic Blood Pressure | Change in Systolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure monitor | Posted | Median | 95% Confidence Interval | mmHg | Baseline, 23 months |
|
|
|
| Secondary | Change in Adherence to Daily Medications | Change in self-reported medication adherence as measured by 5-day recall, 30-day recall and response to Likert-style questions | Data were not collected for this measure and the outcome cannot be reported | Posted | One year after all communities receive intervention |
|
|
| Secondary | Change in Diastolic Blood Pressure | Change in diastolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure | Posted | Median | 95% Confidence Interval | mmHg | Baseline, 23 months |
|
|
|
| Secondary | Disease Control | 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. | Data were not collected and the outcome cannot be reported | Posted | One year after all communities receive intervention |
|
|
| 1 |
| 149 |
| 0 |
| 149 |
| 0 |
| 149 |
| EG001 | CHW Intervention | Patients with hypertension and/or diabetes across seven study communities following CHW intervention. | 1 | 149 | 1 | 149 | 0 | 149 |
|
| Stroke | Nervous system disorders | Systematic Assessment | Stroke would not be expected to result from standard of care or the intervention |
|
Not provided
Not provided
Not provided
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |