REACH Detroit Partnership Family Intervention

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00800410
First received: November 18, 2008
Last updated: December 1, 2008
Last verified: October 2008
  Purpose

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 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.


Condition Intervention Phase
Diabetes Mellitus
Behavioral: Community Health Worker (CHW) services
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot Randomized Diabetes Intervention Among Inner-City African American and Latino Adults

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • LDL cholesterol [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Diabetes self-management knowledge [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Diabetes Self Management and Self Care Activities (physical activity, healthy eating, glucose testing, medication taking, required screening tests/exams) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Diabetes specific emotional distress [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 183
Study Start Date: September 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Information on community resources
Participants received information about free and publicly available community resources on healthy lifestyle activities
Experimental: Community Health Worker services 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800410

Locations
United States, Michigan
Community Health and Social Services (CHASS)
Detroit, Michigan, United States, 48209
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Michael S Spencer, PhD, MSW University of Michigan
  More Information

No publications provided

Responsible Party: Michael Spencer, Associate Professor, University of Michigan School of Social Work
ClinicalTrials.gov Identifier: NCT00800410     History of Changes
Other Study ID Numbers: F012089-049555, 5 P60 DK 020572
Study First Received: November 18, 2008
Last Updated: December 1, 2008
Health Authority: United States: Federal Government

Keywords provided by University of Michigan:
Randomized Controlled Trial

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 23, 2014