MATCH: The Mexican-American Trial of Community Health Workers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven K. Rothschild, MD, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01067092
First received: February 9, 2010
Last updated: November 30, 2011
Last verified: November 2011

February 9, 2010
November 30, 2011
May 2005
December 2010   (final data collection date for primary outcome measure)
  • Hemoglobin A1c [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • % of persons with blood pressure less than 130/80 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01067092 on ClinicalTrials.gov Archive Site
  • Medication adherence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Daily self-blood glucose monitoring [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Summary of Diabetes Self-Care Activities [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
MATCH: The Mexican-American Trial of Community Health Workers
MATCH: The Mexican-American Trial of Community Health Workers

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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.
    Other Names:
    • Promotora
    • Promotora de Salud
  • Behavioral: 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.
  • 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.
    Intervention: Behavioral: Community Health Worker Intervention
  • 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.
    Intervention: Behavioral: Educational Newsletter

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
144
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01067092
R01DK61289, R01DK061289
Yes
Steven K. Rothschild, MD, Rush University Medical Center
Rush University Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Rush University Medical Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP