MATCH: The Mexican-American Trial of Community Health Workers

Diabetes Mellitus, Type 2 Clinical Trial

— MATCH  

Official title:

MATCH: The Mexican-American Trial of Community Health Workers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067092
• Other study ID #: R01DK061289
• Secondary ID: R01DK061289
• Status: Completed
• Phase: N/A
• First received: February 9, 2010
• Last updated: November 30, 2011
• Start date: May 2005
• Est. completion date: December 2010

Study information

• Verified date: November 2011
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c		2 years	No
Primary	% of persons with blood pressure less than 130/80		2 years	No
Secondary	Medication adherence		2 years	No
Secondary	Daily self-blood glucose monitoring		2 years	No
Secondary	Summary of Diabetes Self-Care Activities		2 years	No