REACH Detroit Partnership Family Intervention

Study Overview
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Community Health Worker (CHW) services


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Information on community resources<br>Participants received information about free and publicly available community resources on healthy lifestyle activities | |
| Experimental: Community Health Worker services<br> | Behavioral: Community Health Worker (CHW) services<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Controlled Trial