Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
BEHAVIORALPhysician-patient quality circle
Intervention: (To be compared with standard care) 1. Interprofessionnal meeting per neighbourhood: (beforehand) Therapeutic patient education (TPE) training for healthcare professionals 2. Physician-patient quality circle t0 Group sessions (n= 3 to 6 patients) with doctor and therapeutic patient education specialist Clinical measurements - CM (incl. HbA1c, body composition, blood pressure). PROM evaluation questionnaires (EQ5D&DIABQ) 3. Development of individualised T2D programme: with case manager 4. Quarterly follow-up: t3, t6, t9 months PROM follow-up (DIABQ&PHQ9) +CM. 5. Evaluation of experience: t12 & t18 months PREM&PROM evaluation questionnaire +CM
Sponsors
University of St.Gallen
Réseau de soins Delta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
The clinical trial has a complex trial design. The clinical trial is not a Decentralized Clinical Trials-DCT, nor has decentralized elements
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with newly diagnosed type 2 diabetes (less than 10 years) * Age (between 40 and 65)
Exclusion criteria
* Significant comorbidities linked to worsening diabetes (such as renal failure, previous myocardial infarction, retinopathy, signs or symptoms of severe diabetic neuropathy or diabetic foot ulcers), severe osteoarthritis or as judged by the attending physician. * Pregnant or breast-feeding women * Persons who are unable to give signed informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycated haemoglobin HbA1c (∆HbA1c) | During 18 month | Mean change in glycated haemoglobin HbA1c (∆HbA1c) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life (∆ EQ-5D-5L) | During 18 months | 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. |
| Diabetes self-care behaviours measured by the Diabetes Intention, Attitude, and Behavior Questionnaire (∆ DIAB-Q) | During 18 months | 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. |
| Fat/lean body mass (∆ body composition) | During 18 months | Mean change in body fat/lean body mass (∆ body composition) |
| Cost-effectiveness analysis | At 12 and 18 months | Cost-effectiveness analysis (∆HbA1c; costs assessed from the payer's point of view) |
Contacts
Primary ContactMinette-Joëlle MJ Zeukeng, PharmD, PhD, FPH, RPh
Backup ContactPhilippe Schaller, MD, MPH, FMH
Outcome results
None listed