REACH Detroit Partnership Family Intervention

Diabetes Mellitus Clinical Trial

Official title:

A Pilot Randomized Diabetes Intervention Among Inner-city African American and Latino Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800410
• Other study ID #: F012089-049555
• Secondary ID: 5P60DK020572
• Status: Completed
• Phase: Phase 2
• First received: November 18, 2008
• Last updated: May 25, 2016
• Start date: September 2004
• Est. completion date: July 2006

Study information

• Verified date: May 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Community Health Worker (CHW) services
CHW services included access to an 11 week healthy lifestyle education curriculum, two home visits per month, two additional phone contacts per month, and accompanied participants to one clinic visit within the six month intervention period

Locations

Country	Name	City	State
United States	Community Health and Social Services (CHASS)	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c		6 months	No
Secondary	LDL cholesterol		6 months	No
Secondary	Blood pressure		6 months	No
Secondary	Diabetes self-management knowledge		6 months	No
Secondary	Diabetes Self Management and Self Care Activities (physical activity, healthy eating, glucose testing, medication taking, required screening tests/exams)		6 months	No
Secondary	Diabetes specific emotional distress		6 months	No