Diabetes Mellitus, Type 2NCT01861756
The Diabetes Medication Choice Cards Trial in Greece
A study testing Diabetes Medication Choice decision aid in people with Diabetes Mellitus, Type 2, run by Aristotle University Of Thessaloniki at 8 sites in Greece.
Trial summary
A cluster randomized trial to assess the efficacy of the Diabetes Medication Choice decision aid among Greek patients with type 2 diabetes mellitus compared with usual care. The tool will serve as a facilitator for the Shared Decision Making process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Diabetes Medication Choice decision aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 8 sitesGreece
- Study dates
- May 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Type 2 diabetes mellitus for more than one year
- Agree to be followed for at least 6 months
- Willing to respond to survey questions immediately following the visit
- HbA1c value between 7.5% and 10%
- Need treatment intensification and there are more than one available treatment options
Who cannot join
- Decide not to intensify treatment or to intensify treatment through lifestyle modification, which is a sine qua non for diabetes treatment
- Is to transfer to another practice within the next 6 months
- Significant cognitive (e.g. dementia) or sensory limitations (e.g. blind) or other reasons (e.g. fatigue, limited attention, sleep deprivation) for which, in the judgment of the study personnel, they could not reasonably provide written informed consent or be able to use the decision aid
- Planning to enter a long-term care facility (e.g. nursing home) where medications will be administered by clinical personnel after hospital discharge
- Enrolled in other studies that require prolonged participation and follow-up
- Unable to speak Greek at a level necessary to complete the patient surveys and ensure involvement in decision making
- Women known to be pregnant
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Greece8 sites
Alexandroupoli University Hospital
Alexandroupoli
NIMTS Military Hospital
Athens
Polikliniki General Hospital
Athens
Nea Michaniona Health Center
Néa Michanióna, Thessaloniki
Private practice
Neapoli, Thessaloniki
Tzanio General Hospital
Piraeus, Attica
Private practice
Serres
Thermi S.A.
Thermi, Thessaloniki
About this study
A cluster randomized trial to assess the efficacy of the Diabetes Medication Choice decision aid among Greek patients with type 2 diabetes mellitus compared with usual care. The tool will serve as a facilitator for the Shared Decision Making process.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Diabetes Medication Choice decision aid
- Keywords
- Shared Decision Making, Decision Aids
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Medication Choice decision aidOther
The Diabetes Medication Choice decision aid cards provide information about medications commonly used to treat type 2 diabetes mellitus. The tool was originally developed and successfully evaluated by Mayo Clinic researchers.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Medication Choice Decision Aid | Experimental | Not described Receives: Other: Diabetes Medication Choice decision aid |
| Standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Decisional Comfort (0-100, 100=no Conflict)
Quality of the decision making process assessed by means of the Decisional Conflict Scale
Measured: Day 1
Secondary outcomes (4)
Degree of Patient Knowledge About Available Treatment Alternatives
Patients will complete a 6-item questionnaire addressing general knowledge about type 2 diabetes.
Measured: Day 1
Patient and Clinician Satisfaction With the Decision Making Process
Patient satisfaction will be assessed using items from the Decisional Conflict Scale as well as two specific questions that require patients to assess the extent to which they would want for themselves and recommend to others similar decision support.
Clinician satisfaction will be assessed using a 6-point likert-type question asking about their satisfaction regarding the discussion they had with their patient.
Measured: Day 1
Adherence With Antihyperglycemic Regimens as Reported by the Patient Himself/Herself or Assessed Utilizing the Pharmacy Records
Measured: 3 and 6 months after patient initial encounter
Glycemic Control (HbA1c)
Measured: 3 and 6 months after patient initial encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startMay 2013
- Primary completionFeb 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- European Foundation for the Study of Diabetes, Mayo Clinic
- Responsible party
- Principal investigator, Apostolos Tsapas, Aristotle University Of Thessaloniki
- Investigators
- Apostolos Tsapas, MD, MSc, PhD, Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861756
- Sponsor's protocol ID
- AUTH87963
- Other IDs
- U1111-1138-2901
- Status last verified
- Jan 2017
- First submitted
- 20 May 2013
- Last updated
- 13 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Karagiannis T, Liakos A, Branda ME, Athanasiadou E, Mainou M, Boura P, Goulis DG, LeBlanc A, Montori VM, Tsapas A. Use of the Diabetes Medication Choice Decision Aid in patients with type 2 diabetes in Greece: a cluster randomised trial. BMJ Open. 2016 Nov 14;6(11):e012185. doi: 10.1136/bmjopen-2016-012185.
PubMed 28186933
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diabetes Medication Choice Cards Trial in Greece
- ClinicalTrials.gov ID
- NCT01861756
- Acronym / sponsor ID
- AUTH87963
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Shared Decision Making, Decision Aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- European Foundation for the Study of Diabetes, Mayo Clinic
- Study start
- May 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 24 May 2013 (estimated)
- Results
- Posted 13 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A cluster randomized trial to assess the efficacy of the Diabetes Medication Choice decision aid among Greek patients with type 2 diabetes mellitus compared with usual care. The tool will serve as a facilitator for the Shared Decision Making process.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Medication Choice Decision Aid | Experimental | Other: Diabetes Medication Choice decision aid |
| Standard care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes mellitus for more than one year
- Agree to be followed for at least 6 months
- Willing to respond to survey questions immediately following the visit
- HbA1c value between 7.5% and 10%
- Need treatment intensification and there are more than one available treatment options
Key exclusion criteria (7 listed)
- Decide not to intensify treatment or to intensify treatment through lifestyle modification, which is a sine qua non for diabetes treatment
- Is to transfer to another practice within the next 6 months
- Significant cognitive (e.g. dementia) or sensory limitations (e.g. blind) or other reasons (e.g. fatigue, limited attention, sleep deprivation) for which, in the judgment of the study personnel, they could not reasonably provide written informed consent or be able to use the decision aid
- Planning to enter a long-term care facility (e.g. nursing home) where medications will be administered by clinical personnel after hospital discharge
- Enrolled in other studies that require prolonged participation and follow-up
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 Diabetes Medication Choice decision aid cards provide information about medications commonly used to treat type 2 diabetes mellitus. The tool was originally developed and successfully evaluated by Mayo Clinic researchers. | Other | Diabetes Medication Choice Decision Aid |
Primary outcome
Overall Decisional Comfort (0-100, 100=no Conflict)
Time frame: Day 1
Quality of the decision making process assessed by means of the Decisional Conflict Scale
4 secondary outcomes
Degree of Patient Knowledge About Available Treatment Alternatives
Time frame: Day 1
Patient and Clinician Satisfaction With the Decision Making Process
Time frame: Day 1
Adherence With Antihyperglycemic Regimens as Reported by the Patient Himself/Herself or Assessed Utilizing the Pharmacy Records
Time frame: 3 and 6 months after patient initial encounter
Glycemic Control (HbA1c)
Time frame: 3 and 6 months after patient initial encounter
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28186933Karagiannis T, Liakos A, Branda ME, Athanasiadou E, Mainou M, Boura P, Goulis DG, LeBlanc A, Montori VM, Tsapas A. Use of the Diabetes Medication Choice Decision Aid in patients with type 2 diabetes in Greece: a cluster randomised trial. BMJ Open. 2016 Nov 14;6(11):e012185. doi: 10.1136/bmjopen-2016-012185.
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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.
Apostolos Tsapas, MD, MSc, PhD principal investigator
Aristotle University Of Thessaloniki
8 sites 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 Diabetes Mellitus, Type 2, run by Aristotle University Of Thessaloniki at 8 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. 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 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Greece. 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?
Yes. Results are posted in the registry (first posted 13 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Decisional Comfort (0-100, 100=no Conflict) (time frame: Day 1). 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 NCT01861756, which also lists 1 linked publication.
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 13 Mar 2017.