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Clinical Trials/NCT01427660
NCT01427660CompletedNot Applicable

Technologically Enhanced Community Health Worker (CHW) Delivery of Personalized Diabetes Information

University of Michigan2 sites in 1 country190 target enrollmentStarted: September 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
190
Locations
2
Primary Endpoint
Changes in decisional conflict

Study Overview

Brief Summary

Two of AHRQ 's consumer-focused guides, "Pills for Type 2 Diabetes" and "Premixed Insulin for Type 2 Diabetes" could be of great use to underserved ethnic and racial minority adults. The presentation of content and delivery mechanisms of these Guides, however, needs to be modified to increase their use and impact among these difficult-to-reach populations.

To achieve this goal, a long-standing collaboration among African American and Latino community organizations, health care centers and systems, public health organizations, and academics (the REACH Detroit Partnership) is joining with leading experts in the development of personally and culturally tailored health decision aids (University of Michigan's Center for Health Communications Research [CHCR] and Center for Behavioral and Decision Sciences in Medicine [CBDSM]).

The investigators will develop and evaluate a computer tailored online diabetes medication decision aid that will enable community health workers (CHWs) to provide personalized patient education materials to underserved diabetic African American and Latino adults in Detroit, Michigan.

Detailed Description

The Specific Aims of this study are:

Aim 1: To use the information in the two diabetes medications consumer CERSGs to build an interactive, computer tailored diabetes medication guide that will enable patients to assess their treatment goals, personal preferences, and side-effect concerns and generate a personally tailored assessment of their current diabetes treatments with, as appropriate, options for improving their diabetes care;

Aim 2: To determine the extent to which this personally tailored diabetes medication guide compared with the print consumer guides reduces Latino and African American diabetes patients' decisional conflict, through improved knowledge of anti-hyperglycemic medications and satisfaction with information received.

Aim 3: To examine the computer tailored program's effects on participants' changes in medications (medication intensification), self-reported medication adherence and beliefs and A1C levels between baseline and follow-up compared to participants receiving the print consumer guides.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • type 2 diabetes
  • stated concern about diabetes and diabetes treatment
  • poor glycemic control
  • over 21 years of age

Exclusion Criteria

  • blind, deaf, otherwise unable to use the telephone or visual resources
  • currently enrolled in other REACH Detroit research study
  • in hospice care
  • current radiation or chemotherapy

Outcomes

Primary Outcomes

Changes in decisional conflict

Time Frame: baseline and 3 month post intervention

We will be measuring subjects' perceptions of: a) uncertainty in choosing options; b) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and c) effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice.

Secondary Outcomes

  • Medication adherence and intensification(baseline and 3 month post intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rebecca Mase

Project Manager

University of Michigan

Study Sites (2)

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