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| ID | Type | Description | Link |
|---|---|---|---|
| SNCTP000006190 | Other Identifier | Swiss National Clinical Trials Portal |
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| Name | Class |
|---|---|
| University of St.Gallen | OTHER |
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The aim of this study is to obtain a better glycemic index score (decrease) by improving the care and quality of life of type 2 diabetic patients for a possible remission of diabetes.
This will be achieved through an intervention that includes a strategy for training primary care physicians and other healthcare professionals in patient therapeutic education (TPE), as well as group and/or individual TPE-related activities/tools made available to patients, funded and encouraged for individualized planning. Intervention follow-up will be carried out by means of quality-of-life questionnaires for patients who have undergone the new method, compared with patients who have received the usual care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | Usual care | |
| Intervention arm | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physician-patient quality circle | Behavioral | Intervention: (To be compared with standard care)
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| Measure | Description | Time Frame |
|---|---|---|
| Glycated haemoglobin HbA1c (∆HbA1c) | Mean change in glycated haemoglobin HbA1c (∆HbA1c) | During 18 month |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life (∆ EQ-5D-5L) | Mean change in health-related quality of life (∆ EQ-5D-5L). The EuroQol 5-Dimension 5-Level Health Questionnaire (EQ-5D-5L) scale measures health-related quality of life, including five dimensions, each rated on five levels. Utility scores range from -0.59 (negative scores are considered as worse than death) to 1.000 (perfect health), with higher scores indicating better health. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minette-Joëlle MJ Zeukeng, PharmD, PhD, FPH, RPh | Contact | 0041798921981 | minette.zeukeng@reseau-delta.ch | |
| Philippe Schaller, MD, MPH, FMH | Contact | 0041796525116 | philippe.schaller@reseau-delta.ch |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Geissler, PhD | University of St.Gallen | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41437100 | Derived | Ehlig D, Sapin M, Zeukeng MJ, Vogel J, Barthassat V, Favre B, DaCosta H, Tugay K, Coendoz-Carron S, Bumann D, Coclet J, Schaller P, Geissler A. Enhancing type 2 diabetes care by an individualized and group-based therapeutic patient education program: study protocol for a cluster randomized trial. Trials. 2025 Dec 23;26(1):577. doi: 10.1186/s13063-025-09302-x. |
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Depends on authorities
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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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The clinical trial has a complex trial design. The clinical trial is not a Decentralized Clinical Trials-DCT, nor has decentralized elements
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| During 18 months |
| Diabetes self-care behaviours measured by the Diabetes Intention, Attitude, and Behavior Questionnaire (∆ DIAB-Q) | Mean change in intention to adopt diabetes self-care behaviours (∆ DIAB-Q). Scores range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better outcomes and less impact of diabetes on daily life. | During 18 months |
| Fat/lean body mass (∆ body composition) | Mean change in body fat/lean body mass (∆ body composition) | During 18 months |
| Cost-effectiveness analysis | Cost-effectiveness analysis (∆HbA1c; costs assessed from the payer's point of view) | At 12 and 18 months |
| D004700 | Endocrine System Diseases |