iDecide.Decido: Diabetes Medication Decision Support Study
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 31, 2011 | ||||||||
| Last Updated Date | December 12, 2011 | ||||||||
| Start Date ICMJE | September 2011 | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Changes in decisional conflict [ Time Frame: baseline and 3 month post intervention ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01427660 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Medication adherence and intensification [ Time Frame: baseline and 3 month post intervention ] [ Designated as safety issue: No ] 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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | iDecide.Decido: Diabetes Medication Decision Support Study | ||||||||
| Official Title ICMJE | Technologically Enhanced Community Health Worker (CHW) Delivery of Personalized Diabetes 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
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| Condition ICMJE | Diabetes, Type 2 | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 210 | ||||||||
| Estimated Completion Date | October 2013 | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 21 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01427660 | ||||||||
| Other Study ID Numbers ICMJE | 1R18HS019256-01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Rebecca Mase, University of Michigan | ||||||||
| Study Sponsor ICMJE | University of Michigan | ||||||||
| Collaborators ICMJE | Agency for Healthcare Research and Quality (AHRQ) | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Michigan | ||||||||
| Verification Date | December 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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