NCT01067092

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started May 2005

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 2, 2011

Status Verified

November 1, 2011

Enrollment Period

5.6 years

First QC Date

February 9, 2010

Last Update Submit

November 30, 2011

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • Hemoglobin A1c

    2 years

  • % of persons with blood pressure less than 130/80

    2 years

Secondary Outcomes (3)

  • Medication adherence

    2 years

  • Daily self-blood glucose monitoring

    2 years

  • Summary of Diabetes Self-Care Activities

    2 years

Study Arms (2)

Community Health Worker Intervention

EXPERIMENTAL

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.

Behavioral: Community Health Worker Intervention

Educational Newsletter

ACTIVE COMPARATOR

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.

Behavioral: Educational Newsletter

Interventions

Community Health Worker InterventionBEHAVIORAL

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.

Also known as: Promotora, Promotora de Salud
Community Health Worker Intervention
Educational NewsletterBEHAVIORAL

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.

Educational Newsletter

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (2)

  • 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.

    PMID: 20008279BACKGROUND

  • 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.

    PMID: 21462723BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 9, 2010

First Posted

February 11, 2010

Study Start

May 1, 2005

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 2, 2011

Record last verified: 2011-11

Locations

US(1)