Clinical trial NCT01427660: iDecide.Decido: Diabetes Medication Decision Support Study
Official title: Technologically Enhanced Community Health Worker (CHW) Delivery of Personalized Diabetes Information
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes, Type 2
Keywords: Diabetes
Decision Aid
AntiHyperglycemic Medication
Tailored health information
Medication information
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2011-09-01
Enrollment: 190
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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
* pregnant
* currently enrolled in other REACH Detroit research study
* in hospice care
* current radiation or chemotherapy

Primary outcomes:
measure: Changes in decisional conflict
timeFrame: baseline and 3 month post intervention
Secondary outcomes:
measure: Medication adherence and intensification
timeFrame: baseline and 3 month post intervention
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Community Health and Social Service (CHASS)
state: Michigan
Study officials:
affiliation: University of Michigan Meidcal School; Ann Arbor VA Center for Clinical Management Research,
name: Michele Heisler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heisler M, Choi H, Palmisano G, Mase R, Richardson C, Fagerlin A, Montori VM, Spencer M, An LC. Comparison of community health worker-led diabetes medication decision-making support for low-income Latino and African American adults with diabetes using e-health tools versus print materials: a randomized, controlled trial. Ann Intern Med. 2014 Nov 18;161(10 Suppl):S13-22. doi: 10.7326/M13-3012.