Diabetes Mellitus, Type 2, Hypertension
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Harvard University
Brigham and Women's Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Formal diagnosis of Type II Diabetes Mellitus, Stage I or II Hypertension or both * Daily medications required for patient's condition * Residence and receipt of therapy within the study catchment area * Age greater than or equal to 18 years.
Exclusion criteria
* Known or suspected secondary hypertension * Known or suspected Type 1 diabetes * Pregnancy * Chronic use of glucocorticoids.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c | Baseline, 23 months | Change in percent glycated hemoglobin as measured by PTS diagnostics point-of-care assay |
| Change in Systolic Blood Pressure | Baseline, 23 months | Change in Systolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Adherence to Daily Medications | One year after all communities receive intervention | Change in self-reported medication adherence as measured by 5-day recall, 30-day recall and response to Likert-style questions |
| Change in Diastolic Blood Pressure | Baseline, 23 months | Change in diastolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure |
| Disease Control | One year after all communities receive intervention | 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. |
Countries
United States
Participant flow
Recruitment details
Patients with diabetes, hypertension and respective risk factors were identified via a CES programme of clinic-based and door-to-door case finding.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 149 |
| Total | 149 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Physician Decision | 22 |
| Overall Study | Protocol Violation | 6 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Patients With Diabetes or Hypertension |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 42 Participants |
| Age, Categorical Between 18 and 65 years | 107 Participants |
| Age, Continuous | 58 years |
| Diabetes diagnosis | 70 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 149 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Has a car/motorcycle | 43 Participants |
| Has a radio | 93 Participants |
| HbA1c | 9.3 percent of glycosylated hemoglobin |
| Hypertension diagnosis | 110 Participants |
| Region of Enrollment Mexico | 149 participants |
| Sex: Female, Male Female | 96 Participants |
| Sex: Female, Male Male | 53 Participants |
| Systolic Blood Pressure | 135 mm Hg |
| Type of remuneration Day labour | 58 Participants |
| Type of remuneration None | 83 Participants |
| Type of remuneration Salary | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 149 | 1 / 149 |
| other Total, other adverse events | 0 / 149 | 0 / 149 |
| serious Total, serious adverse events | 0 / 149 | 1 / 149 |
Outcome results
Primary
Change in Hemoglobin A1c
Change in percent glycated hemoglobin as measured by PTS diagnostics point-of-care assay
Time frame: Baseline, 23 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients With Diabetes | Change in Hemoglobin A1c | -0.35 percentage of glycated hemoglobin |
Primary
Change in Systolic Blood Pressure
Change in Systolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure monitor
Time frame: Baseline, 23 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients With Diabetes | Change in Systolic Blood Pressure | -4.7 mmHg |
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
Time frame: One year after all communities receive intervention
Population: Data were not collected for this measure and the outcome cannot be reported
Secondary
Change in Diastolic Blood Pressure
Change in diastolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure
Time frame: Baseline, 23 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients With Diabetes | Change in Diastolic Blood Pressure | -2.2 mmHg |
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.
Time frame: One year after all communities receive intervention
Population: Data were not collected and the outcome cannot be reported