Multi-clinic Action Trial to Control Hyperglycemia and Hypertension

NCT02759484 | Completed DMC

• 1 other identifier: 12052906
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 3

Brief Summary

The MATCH2 Study (The Multi-clinic Action Trial to Control Hyperglycemia and Hypertension) is a randomized controlled trial comparing two educational approaches to improve glucose and blood pressure control in African American and Latino adults with type 2 diabetes. The study is being designed and implemented using a Community Based Participatory Research approach to optimize the two educational approaches. One approach, Enhanced Home Based Education, adapts a Community Health Worker (CHW) intervention from the protocol of the prior Mexican-American Trial of Community Health workers (MATCH). The other approach, Enhanced Clinic Based Education, uses a Certified Diabetes Educator (CDE) to deliver dietary and general self-management education. The study seeks to determine if Community Health Workers working as part of the primary care clinical team can reduce health disparities and improve outcomes among patients with type 2 diabetes.

Conditions

Diabetes Mellitus, Type 2

Keywords

CHWs; Health Education; Disease Self Management

Outcome Measures

Primary Outcomes (2)

• Glycemic Control

  Glycemic control will be determined by Hemoglobin A1c, measured on a fingerstick collected Dried Blood Spot test, and analyzed by an independent reference lab.

  Up to 18 months post randomization

• Blood Pressure Control

  Blood Pressure (BP) will be measured three times using an automated blood pressure cuff with the participant in a seated position. Mean Arterial Pressure will be calculated by the standard formula: Diastolic BP + 1/3 (Systolic BP - Diastolic BP)\] .

  Up to 18 months post randomization

Secondary Outcomes (5)

• Maintenance of Glycemic Control

  Up to 24 months post randomization

• Maintenance of Blood Pressure Control

  Up to 24 months post randomization

• Intermediate Behavior: Dietary Adherence

  Up to 18 months

• Intermediate Behavior: Physical Activity

  Up to 18 months

• Intermediate Behavior: Medication Adherence

  Up to 18 months

Other Outcomes (1)

• Intervention Costs

  Up to 24 months

Study Arms (2)

Home Based Enhanced Education

EXPERIMENTAL

The Home Based Enhanced Education arm consists of a diabetes self-management curriculum delivered by Community Health Workers in the participant's home.

Behavioral: Home Based Enhanced Education

Clinic Based Enhanced Education

ACTIVE COMPARATOR

The Clinic Based Enhanced Education arm consists of group diabetes self-management education, delivered by a Certified Diabetes Educator, plus mailed diabetes self-management education.

Behavioral: Clinic Based Enhanced Education

Interventions

Home Based Enhanced Education BEHAVIORAL

The Home Based Enhanced Education arm consists of a diabetes self-management curriculum delivered by Community Health Workers in the participant's home. Participants receive 24 visits: 12 biweekly visits in the first 6 months, followed by 12 monthly visits in months 6 through 18 of the study. The self-management program is derived from two pragmatic evidence-based frameworks for behavioral change.

Also known as: Community Health Worker intervention (CHW)

Home Based Enhanced Education

Clinic Based Enhanced Education BEHAVIORAL

The Clinic Based Enhanced Education arm consists of two two-hour-long sessions of group diabetes self-management education, delivered by a Certified Diabetes Educator. Participants in this arm will also receive 24 newsletters with diabetes self-management education.

Also known as: Diabetes Educator intervention

Clinic Based Enhanced Education

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 2 diabetes mellitus with A1c greater than or equal to 7.0
• At least 18 years of age and capable of giving informed consent in either English or Spanish
• Primary care received through a participating clinic
• Participants must identify themselves as either Black / African American race or Hispanic / Latino ethnicity

You may not qualify if:

• Have end-stage renal disease, stroke, or other major end-organ complication of diabetes
• Require chronic prednisone or other systemic corticosteroid use
• Are receiving treatment for a major psychiatric disorder (i.e. schizophrenia)
• Live in a household with someone who is already a randomized study participant

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (3)

Rush University Internists

Chicago, Illinois, 60612, United States

Location

Erie Family Health Center

Chicago, Illinois, 60622, United States

Location

Cicero Health Center of Cook County

Cicero, Illinois, 60804, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Health Education

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Steven K Rothschild, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: May 3, 2016
• Study Start: March 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2019
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

US (3)