NCT00800410

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P50-P75 for phase_2 diabetes-mellitus

Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 2, 2008

Completed
Last Updated

May 27, 2016

Status Verified

May 1, 2016

Enrollment Period

1.8 years

First QC Date

November 18, 2008

Last Update Submit

May 25, 2016

Conditions

Diabetes Mellitus

Keywords

Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    6 months

Secondary Outcomes (5)

  • 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

Study Arms (2)

Information on community resources

NO INTERVENTION

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

Community Health Worker services

EXPERIMENTAL
Behavioral: Community Health Worker (CHW) services

Interventions

Community Health Worker (CHW) servicesBEHAVIORAL

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

Community Health Worker services

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Health and Social Services (CHASS)

Detroit, Michigan, 48209, United States

Location

Related Publications (2)

  • 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.

    PMID: 29703724DERIVED

  • 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.

    PMID: 26234800DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Allied Health PersonnelHealth PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Michael S Spencer, PhD, MSW

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 18, 2008

First Posted

December 2, 2008

Study Start

September 1, 2004

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

May 27, 2016

Record last verified: 2016-05

Locations

US(1)