REACH Detroit Partnership Family Intervention

Phase 2

Completed

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: Community Health Worker (CHW) services

• Registration Number: NCT00800410
• Lead Sponsor: University of Michigan

Brief Summary

The objectives of the proposed study are to determine whether culturally diverse community residents with diabetes are willing to participate in our community health worker intervention using randomized controlled trial (RCT) methods and to explore and document effective processes and protocols for RCT methods in these communities. The investigators will examine retention rates, identify reasons for attrition through interviews and focus groups, and determine strategies for improving recruitment, retention, and intervention methods. As a secondary objective, the investigators will explore the potential impacts of the intervention for improving healthy lifestyles, diabetes self-management, and selected health outcomes of participants.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Study First Submitted: 2008-11-18
• Study First Submitted QC: 2008-12-01
• Study First Posted: 2008-12-02
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-25
• Last Update Posted: 2016-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

• At least 18 years of age
• Had physician-diagnosed type 2 diabetes
• Self-identified as African American or Latino/Hispanic
• Lived in the targeted zip codes.

Exclusion Criteria

• Individuals who already had serious diabetes-related complications, such as blindness, amputated limbs, and kidney failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Community Health Worker services	Community Health Worker (CHW) services	-

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	6 months

Secondary Outcome Measures

Name	Time	Method
LDL cholesterol	6 months
Blood pressure	6 months
Diabetes self-management knowledge	6 months
Diabetes Self Management and Self Care Activities (physical activity, healthy eating, glucose testing, medication taking, required screening tests/exams)	6 months
Diabetes specific emotional distress	6 months

Trial Locations

Locations (1)

Community Health and Social Services (CHASS); 🇺🇸 Detroit, Michigan, United States