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iDecide.Decido: Diabetes Medication Decision Support Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01427660
Acronym
iDecide
Enrollment
190
Registered
2011-09-01
Start date
2011-09-30
Completion date
2013-10-31
Last updated
2014-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Type 2

Keywords

Diabetes, Decision Aid, AntiHyperglycemic Medication, Tailored health information, Medication information

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.

Interventions

BEHAVIORALCommunity Health Worker Diabetes Education: Print media

Providing information to patients about potential benefits, harms, costs, and burdens of medications and discussing patients' treatment preferences.

BEHAVIORALCHW Diabetes Education: tailored web site

Providing tailored and interactive information to patients about potential benefits, harms, costs, and burdens of medications and discussing patients' treatment preferences.

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
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 * pregnant * currently enrolled in other REACH Detroit research study * in hospice care * current radiation or chemotherapy

Design outcomes

Primary

MeasureTime frameDescription
Changes in decisional conflictbaseline and 3 month post interventionWe 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

MeasureTime frameDescription
Medication adherence and intensificationbaseline and 3 month post interventionSelf-reported medication adherence will be assessed through three well-validated measures. We will assess changes in anti-hyperglycemic medication dosages and/or numbers of medications by patient report and medical record review.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026