REACH Detroit Partnership Family Intervention

NCT ID: NCT00800410

Last Updated: 2016-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-07-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Information on community resources

Participants received information about free and publicly available community resources on healthy lifestyle activities

Group Type NO_INTERVENTION

No interventions assigned to this group

Community Health Worker services

Group Type EXPERIMENTAL

Community Health Worker (CHW) services

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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University of Michigan School of Social Work

Principal Investigators

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Michael S Spencer, PhD, MSW

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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Community Health and Social Services (CHASS)

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29703724 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26234800 (View on PubMed)

Other Identifiers

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5P60DK020572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F012089-049555

Identifier Type: -

Identifier Source: org_study_id

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