E10 E11
Conditions
Interventions
Group 1: At the start of the study (t1) and prior to the coaching phase (t2), patients/participants complete a questionnaire on diabetes-related emotional burden (PAID). If significant diabetes-relate
double sessions (i.e., two sessions held during a single appointment (90–120 minutes) are also possible. The program is designed to be completed within a three-month period. Depending on the number of
Sponsors
Forschungsinstitut der Diabetes-Akademie Bad Mergentheim (FIDAM GmbH)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Presence of diabetes mellitus • PAID score = 40 • Participation in a structured diabetes education program • Proficiency in spoken and written German • Provision of a written declaration of consent
Exclusion criteria
Exclusion criteria: • Presence of a wasting disease associated with emaciation and weight loss (cachexia) (e.g., cancer, infectious diseases such as AIDS or tuberculosis) • Presence of a severe co-existing condition that, in the opinion of the study physician, precludes participation in the study • Presence of an acute psychiatric disorder that, in the opinion of the study physician, precludes participation in the study • Concurrent participation in another clinical trial • Lack of capacity to consent due to limited legal capacity, legal incapacity, or legal guardianship • Dependency on the sponsor or clinical investigator (e.g., employees of the sponsor or a study center and their family members)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the comparison (i.e., difference) between the change in the level of diabetes-related distress (PAID score) from t1 to t2 and the change from t2 to t3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the extent of the reduction in diabetes-related distress; changes in various questionnaires assessing general and health-related quality of life, as well as the management of, experiences with, and potential burdens associated with the diabetes; and changes in various medical parameters: • % of patients with a reduction in diabetes-related distress >5% • % of patients with a reduction in diabetes-related distress >10% • General quality of life (WHO-5) • Health-related quality of life (SF-12) • Mood / Depressive symptoms (CESD-R) • General self-efficacy (GSE) • Diabetes empowerment (DES) • Satisfaction with diabetes treatment (DTSQ) • Impact of diabetes (DIPD) • General health literacy (HLS-EU-Q16) • Resilience (RS-13) • HbA1c • Blood pressure • Blood lipid levels • Number of severe hypoglycemic episodes requiring third party assistance | — |
Countries
Germany
Contacts
Public ContactAngelika Deml
Katholische Akademie für Gesundheitsberufe Regensburg
Outcome results
None listed