iDecide.Decido: Diabetes Medication Decision Support Study

Diabetes, Type 2 Clinical Trial

— iDecide  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427660
• Other study ID #: 1R18HS019256-01
• Status: Completed
• Phase: N/A
• First received: August 31, 2011
• Last updated: September 8, 2014
• Start date: September 2011
• Est. completion date: October 2013

Study information

• Verified date: September 2014
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes, Type 2

Intervention

Behavioral:
• Community Health Worker Diabetes Education: Print media
Providing information to patients about potential benefits, harms, costs, and burdens of medications and discussing patients' treatment preferences.
• CHW 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.

Locations

Country	Name	City	State
United States	Community Health and Social Service (CHASS)	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in decisional conflict	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.	baseline and 3 month post intervention	No
Secondary	Medication adherence and intensification	Self-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.	baseline and 3 month post intervention	No