Type 2 DiabetesNCT00388050
Diabetes Medication Choice
A study testing Diabetes Medication Choice decision aid in people with Type 2 Diabetes, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to examine how different ways of sharing information about diabetes medication treatment options with patients can affect their choices and health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Diabetes Medication Choice decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Have a diagnosis of type 2 diabetes mellitus of any duration; c-peptide test not required
- Use 1 or 2 oral hypoglycemic agents; not using insulin therapy
- Are not pregnant
- Have stable but inadequate glycemic control: both A1C at the time of eligibility and previous A1c within 6 months between 7-9.5%
- Recognize their primary care provider as their main diabetes care provider
- Do not have major barriers (i.e., severe hearing impairment, dementia, cannot communicate in English) to participate in shared decision-making (per provider?s assessment)
- Have no plans to relocate out of town in the next 6 months
- Enrolment is open to males and females of diverse racial backgrounds
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wiser Choices for Patients With Type II Diabetes: Diabetes Medication Choice
The purpose of this study is to examine how different ways of sharing information about diabetes medication treatment options with patients can affect their choices and health.
- Conditions
- Type 2 Diabetes
- Being tested
- Diabetes Medication Choice decision aid, Usual Care
- Keywords
- Decision aid, diabetes, primary care
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Medication Choice decision aidBehavioural
The decision aid covers five commonly prescribed anti-hyperglycemic medications and their attributes.
Usual CareBehavioural
Patients and clinicians in this arm will discuss anti-hyperglycemic agents in their usual manner.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Medication Choice decision aid | Experimental | Patients in this arm will discuss diabetes medication for glucose control with the help of a decision aid that covers five commonly prescribed anti-hyperglycemic medications. Receives: Behavioral: Diabetes Medication Choice decision aid |
| Usual Care | Other | Patients and clinicians in this arm will discuss anti-hyperglycemic agents in their usual manner. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding
Measured: Directly proceeding the clinical encounter
Decisional Conflict
Measured: Directly proceeding the clinical visit
Treatment Action, adherence
Measured: Directly proceeding the clinical encounter, 6 months after the clinical encounter
Secondary outcomes (2)
Trust
Measured: Directly proceeding the clinical visit
Acceptability
Measured: Directly proceeding the clinical encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startJul 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Investigators
- Victor M. Montori, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388050
- Sponsor's protocol ID
- 06-003513
- Other IDs
- ADA #33
- Status last verified
- Apr 2015
- First submitted
- 12 Oct 2006
- Last updated
- 28 Apr 2015
- Results posted
- No
Publications
Wyatt KD, Branda ME, Inselman JW, Ting HH, Hess EP, Montori VM, LeBlanc A. Genders of patients and clinicians and their effect on shared decision making: a participant-level meta-analysis. BMC Med Inform Decis Mak. 2014 Sep 2;14:81. doi: 10.1186/1472-6947-14-81.
PubMed 25179289LeBlanc A, Ruud KL, Branda ME, Tiedje K, Boehmer KR, Pencille LJ, Van Houten H, Matthews M, Shah ND, May CR, Yawn BP, Montori VM. The impact of decision aids to enhance shared decision making for diabetes (the DAD study): protocol of a cluster randomized trial. BMC Health Serv Res. 2012 May 28;12:130. doi: 10.1186/1472-6963-12-130.
PubMed 22640439Mullan RJ, Montori VM, Shah ND, Christianson TJ, Bryant SC, Guyatt GH, Perestelo-Perez LI, Stroebel RJ, Yawn BP, Yapuncich V, Breslin MA, Pencille L, Smith SA. The diabetes mellitus medication choice decision aid: a randomized trial. Arch Intern Med. 2009 Sep 28;169(17):1560-8. doi: 10.1001/archinternmed.2009.293.
PubMed 19786674
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wiser Choices for Patients With Type II Diabetes: Diabetes Medication Choice
- ClinicalTrials.gov ID
- NCT00388050
- Acronym / sponsor ID
- 06-003513
- Conditions
- Type 2 Diabetes
- Keywords
- Decision aid, diabetes, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Jul 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 13 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine how different ways of sharing information about diabetes medication treatment options with patients can affect their choices and health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Medication Choice decision aid | Experimental | Behavioral: Diabetes Medication Choice decision aidPatients in this arm will discuss diabetes medication for glucose control with the help of a decision aid that covers five commonly prescribed anti-hyperglycemic medications. |
| Usual Care | Other | Behavioral: Usual CarePatients and clinicians in this arm will discuss anti-hyperglycemic agents in their usual manner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes Medication Choice decision aidThe decision aid covers five commonly prescribed anti-hyperglycemic medications and their attributes. | Behavioural | Diabetes Medication Choice decision aid |
| Usual CarePatients and clinicians in this arm will discuss anti-hyperglycemic agents in their usual manner. | Behavioural | Usual Care |
Primary outcome
Understanding
Time frame: Directly proceeding the clinical encounter
Decisional Conflict
Time frame: Directly proceeding the clinical visit
Treatment Action, adherence
Time frame: Directly proceeding the clinical encounter, 6 months after the clinical encounter
2 secondary outcomes
Trust
Time frame: Directly proceeding the clinical visit
Acceptability
Time frame: Directly proceeding the clinical encounter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Derived from this study: PubMed 25179289Wyatt KD, Branda ME, Inselman JW, Ting HH, Hess EP, Montori VM, LeBlanc A. Genders of patients and clinicians and their effect on shared decision making: a participant-level meta-analysis. BMC Med Inform Decis Mak. 2014 Sep 2;14:81. doi: 10.1186/1472-6947-14-81.
- Derived from this study: PubMed 22640439LeBlanc A, Ruud KL, Branda ME, Tiedje K, Boehmer KR, Pencille LJ, Van Houten H, Matthews M, Shah ND, May CR, Yawn BP, Montori VM. The impact of decision aids to enhance shared decision making for diabetes (the DAD study): protocol of a cluster randomized trial. BMC Health Serv Res. 2012 May 28;12:130. doi: 10.1186/1472-6963-12-130.
- Derived from this study: PubMed 19786674Mullan RJ, Montori VM, Shah ND, Christianson TJ, Bryant SC, Guyatt GH, Perestelo-Perez LI, Stroebel RJ, Yawn BP, Yapuncich V, Breslin MA, Pencille L, Smith SA. The diabetes mellitus medication choice decision aid: a randomized trial. Arch Intern Med. 2009 Sep 28;169(17):1560-8. doi: 10.1001/archinternmed.2009.293.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor M. Montori, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Medication Choice decision aid in people with Type 2 Diabetes, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understanding (time frame: Directly proceeding the clinical encounter). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00388050, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.