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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1138-2901 | Other Identifier | WHO - Universal Trial Number |
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| Name | Class |
|---|---|
| European Foundation for the Study of Diabetes | OTHER |
| Mayo Clinic | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes Medication Choice Decision Aid | Experimental |
| |
| Standard care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Medication Choice decision aid | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Decisional Comfort (0-100, 100=no Conflict) | Quality of the decision making process assessed by means of the Decisional Conflict Scale | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Patient Knowledge About Available Treatment Alternatives | Patients will complete a 6-item questionnaire addressing general knowledge about type 2 diabetes. | Day 1 |
| Patient and Clinician Satisfaction With the Decision Making Process |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Apostolos Tsapas, MD, MSc, PhD | Aristotle University Of Thessaloniki | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tzanio General Hospital | Piraeus | Attica | Greece | |||
| Private practice |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28186933 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diabetes Medication Choice Decision Aid | |
| FG001 | Usual Care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diabetes Medication Choice Decision Aid | |
| BG001 | Usual Care | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Decisional Comfort (0-100, 100=no Conflict) | Quality of the decision making process assessed by means of the Decisional Conflict Scale | Posted | Mean | 95% Confidence Interval | units on a scale | Day 1 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diabetes Medication Choice Decision Aid |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Apostolos Tsapas | Aristotle University Thessaloniki | atsapas@auth.gr |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
| Day 1 |
| Adherence With Antihyperglycemic Regimens as Reported by the Patient Himself/Herself or Assessed Utilizing the Pharmacy Records | 3 and 6 months after patient initial encounter |
| Glycemic Control (HbA1c) | 3 and 6 months after patient initial encounter |
| Neapoli |
| Thessaloniki |
| Greece |
| Nea Michaniona Health Center | Néa Michanióna | Thessaloniki | Greece |
| Thermi S.A. | Thermi | Thessaloniki | Greece |
| Alexandroupoli University Hospital | Alexandroupoli | Greece |
| NIMTS Military Hospital | Athens | Greece |
| Polikliniki General Hospital | Athens | Greece |
| Private practice | Serres | Greece |
Total of all reporting groups
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type 2 diabetes duration | Count of Participants | Participants |
|
| HbA1c | Mean | Standard Deviation | % |
|
|
| Secondary | Degree of Patient Knowledge About Available Treatment Alternatives | Patients will complete a 6-item questionnaire addressing general knowledge about type 2 diabetes. | Not Posted | Day 1 | Participants |
| Secondary | 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. | Not Posted | Day 1 | Participants |
| Secondary | Adherence With Antihyperglycemic Regimens as Reported by the Patient Himself/Herself or Assessed Utilizing the Pharmacy Records | Not Posted | 3 and 6 months after patient initial encounter | Participants |
| Secondary | Glycemic Control (HbA1c) | Not Posted | 3 and 6 months after patient initial encounter | Participants |
| 0 |
| 101 |
| 0 |
| 101 |
| EG001 | Usual Care | 0 | 103 | 0 | 103 |
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| D004700 | Endocrine System Diseases |