- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01067092
MATCH: The Mexican-American Trial of Community Health Workers (MATCH)
The MATCH study (Mexican-American Trial of Community Health Workers) tests the hypothesis that the use of indigenous Community Health Workers (CHWs), recruited from the target community and trained to provide culturally appropriate diabetes education, can promote pro-active self-management among inner-city dwelling Mexican-Americans with Type 2 diabetes mellitus. The study aims are to demonstrate that a CHW, compared to an attention control, will: 1) result in improvement in short term physiologic outcomes (Hemoglobin A1c levels and blood pressure), and 2) result in increased frequency of self-management behaviors (daily self blood-glucose monitoring, medication adherence, adherence to diet and physical activity recommendations). The study design is a single site, partially blinded, randomized controlled trial of 144 patients with Type 2 diabetes mellitus.
Eligibility criteria include a diagnosis of Type 2 diabetes, residence in target community areas in the Chicago area, and Mexican or Mexican-American ethnic heritage. Participants are randomized to either an experimental group receiving 36 home visits over a two year period in which a CHW delivered diabetes education and self-management skills training, or to an attention control consisting of 36 bilingual diabetes education newsletters covering the same curriculum as the CHWs. The curriculum covers recommended diabetes self-management behaviors including glucose self-monitoring, responding to abnormal blood glucose levels, working effectively with health care providers, medication adherence, foot care, daily physical activity, and reducing fat content of diet. CHWs also deliver training in behavioral skills of self-monitoring, environmental restructuring, engagement of social support, stress management, and problem-solving skills to facilitate the self-management activities. Consistent delivery of the CHW intervention is documented by audiotapes and Documentation of Intervention worksheets.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of type 2 diabetes mellitus
- Taking at one oral medication daily to control diabetes
- Self-identified as Mexican or Mexican-American
- Resident in target community within Chicago, Berwyn, or Cicero, Illinois.
Exclusion Criteria:
- Diabetes controlled with diet or insulin only
- Advanced end-organ complications, including: end-stage renal disease, stroke with paresis, Congestive Heart Failure (NYHA class 3 or 4), or other major end-organ complication of diabetes
- Receiving treatment for a major psychiatric disorder (i.e. schizophrenia)
- Are unable to understand and give informed consent in either English or Spanish
- Live in a household with someone who is already a randomized study participant or know of family members who are already study participants.
- Have lived in Mexico for more than four months in the past two years, or are anticipating extended travel to Mexico in the next year.
- Are under the age of 18
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Community Health Worker Intervention
A Community Health Worker makes 36 home visits to the person with diabetes over a two year period, providing diabetes education and self-management skills training.
The curriculum covers recommended diabetes self-management behaviors including glucose self-monitoring, responding to abnormal blood glucose levels, working effectively with health care providers, medication adherence, foot care, daily physical activity, and reducing fat content of diet.
CHWs also deliver training in behavioral skills of self-monitoring, environmental restructuring, engagement of social support, stress management, and problem-solving skills to facilitate the self-management activities.
|
A Community Health Worker makes 36 home visits to the person with diabetes over a two year period, providing diabetes education and self-management skills training.
The curriculum covers recommended diabetes self-management behaviors including glucose self-monitoring, responding to abnormal blood glucose levels, working effectively with health care providers, medication adherence, foot care, daily physical activity, and reducing fat content of diet.
CHWs also deliver training in behavioral skills of self-monitoring, environmental restructuring, engagement of social support, stress management, and problem-solving skills to facilitate the self-management activities.
Other Names:
|
|
Active Comparator: Educational Newsletter
Diabetes education and self-management skills training delivered via 36 bilingual diabetes education newsletters over a 2 year period.
The newsletters cover recommended diabetes self-management behaviors including glucose self-monitoring, responding to abnormal blood glucose levels, working effectively with health care providers, medication adherence, foot care, daily physical activity, and reducing fat content of diet.
The newsletters also describe behavioral skills of self-monitoring, environmental restructuring, engagement of social support, stress management, and problem-solving skills to facilitate the self-management activities.
|
Diabetes education and self-management skills training delivered via 36 bilingual diabetes education newsletters over a 2 year period.
The newsletters cover recommended diabetes self-management behaviors including glucose self-monitoring, responding to abnormal blood glucose levels, working effectively with health care providers, medication adherence, foot care, daily physical activity, and reducing fat content of diet.
The newsletters also describe behavioral skills of self-monitoring, environmental restructuring, engagement of social support, stress management, and problem-solving skills to facilitate the self-management activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hemoglobin A1c
Time Frame: 2 years
|
2 years
|
|
% of persons with blood pressure less than 130/80
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Medication adherence
Time Frame: 2 years
|
2 years
|
|
Daily self-blood glucose monitoring
Time Frame: 2 years
|
2 years
|
|
Summary of Diabetes Self-Care Activities
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Swider SM, Martin M, Lynas C, Rothschild S. Project MATCH: training for a promotora intervention. Diabetes Educ. 2010 Jan-Feb;36(1):98-108. doi: 10.1177/0145721709352381. Epub 2009 Dec 11.
- Martin MA, Swider SM, Olinger T, Avery E, Lynas CM, Carlson K, Rothschild SK. Recruitment of Mexican American adults for an intensive diabetes intervention trial. Ethn Dis. 2011 Winter;21(1):7-12.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DK061289 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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