A Study of the Impact of Decision Aids to Enhance Shared Decision Making for Diabetes
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 09-008640
NCT ID: NCT01029288
Sponsor Protocol Number: 09-008640
About this study
The purpose of this study is to determine the impact of patient decision aids compared to usual care on measures of patient involvement in decision-making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and use of resources in nonurban practices in the Midwestern United States.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Primary care provider is participating in trial
- Adult, ≥ 18 years
- Has type 2 diabetes
- English speaking
- Recognize primary care provider as main diabetes care provider
- Can state is available for follow-up for six months after treatment decision
- Specific for diabetes medication
- Clinical diagnosis of type 2 diabetes for one year or more (c-peptide test is not required)
- Use 0, 1, or 2 oral hypoglycemic agents at maximum doses
- Stable but inadequate glycemic control or worsening glycemic control as identified by most recent HbA1c measure over 7.3% within 12 months of the time of eligibility
- Identified by provider as a medically-appropriate candidate for diabetes medications, (i.e. no contraindications to taking the medications, e.g., allergy)
- Specific for cardiovascular medication
- Clinical diagnosis of type 2 diabetes for any duration (c-peptide test is not required)
- Identified by provider as a medically-appropriate candidate for statins, (i.e. no contraindications to taking the medications, e.g., allergy)
Exclusion Criteria
- Major barriers to providing written informed consent and participating in shared decision making (i.e. severe vision or hearing impairment, cognitive impairment, non-English speaking)
- Specific for diabetes medication
- Specific for cardiovascular medication
- Use a statin currently
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Victor Montori, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available