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CompletedNCT00800410Updated May 27, 2016

REACH Detroit Partnership Family Intervention

A Phase 2 interventional study of Community Health Worker (CHW) services in Diabetes Mellitus, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-27.

Sponsored by University of Michigan · Phase 2, Interventional, and Supportive care

Phase
Phase 2
Study type
Interventional
Enrollment
183
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus

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Keywords

  • Randomized Controlled Trial
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 183 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,476 studies on the registry; 197 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Individuals who already had serious diabetes-related complications, such as blindness, amputated limbs, and kidney failure
05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
183 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralCommunity 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

06

What researchers measure

Primary outcomes

  1. Hemoglobin A1c

    Time frame: 6 months

Secondary outcomes

  1. LDL cholesterol

    Time frame: 6 months

  2. Blood pressure

    Time frame: 6 months

  3. Diabetes self-management knowledge

    Time frame: 6 months

  4. Diabetes Self Management and Self Care Activities (physical activity, healthy eating, glucose testing, medication taking, required screening tests/exams)

    Time frame: 6 months

  5. Diabetes specific emotional distress

    Time frame: 6 months

07

Study locations

1 site
  • Community Health and Social Services (CHASS)
    Detroit, Michigan 48209, United States
08

References and documents

Publications

  • Spencer MS, Kieffer EC, Sinco B, Piatt G, Palmisano G, Hawkins J, Lebron A, Espitia N, Tang T, Funnell M, Heisler M. Outcomes at 18 Months From a Community Health Worker and Peer Leader Diabetes Self-Management Program for Latino Adults. Diabetes Care. 2018 Jul;41(7):1414-1422. doi: 10.2337/dc17-0978. Epub 2018 Apr 27. PubMed 29703724 ↗
  • Rosland AM, Kieffer E, Spencer M, Sinco B, Palmisano G, Valerio M, Nicklett E, Heisler M. Do pre-existing diabetes social support or depressive symptoms influence the effectiveness of a diabetes management intervention? Patient Educ Couns. 2015 Nov;98(11):1402-9. doi: 10.1016/j.pec.2015.05.019. Epub 2015 Jun 5. PubMed 26234800 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00800410
Lead sponsor
University of Michigan
Collaborators
Centers for Disease Control and Prevention
First posted
Dec 2, 2008
Start date
Sep 2004
Primary completion
Jul 2006
Completion
Jul 2006
Last update
May 27, 2016

Study contacts

Michael S Spencer, PhD, MSW
principal investigator · University of Michigan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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