Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Diabetes-related distress is a psychological construct associated with poorer glycaemic control in people living with diabetes. In France, few data are available on this topic and none focus specifically on adults with type 2 diabetes. Diabetes-related distress is not mentioned in the current French national guidelines on the management of type 2 diabetes, whereas international societies such as the ADA and, more recently, the EASD now recommend its regular assessment.
This single-centre observational study conducted in the endocrinology department of Nice University Hospital aims to estimate the prevalence of severe diabetes-related distress in adults with type 2 diabetes receiving usual care, and to identify associated clinical, psychosocial and lifestyle factors. Participants complete validated self-report questionnaires (PAID-20 for diabetes distress, WHOQOL-BREF for quality of life, and a modified Starting The Conversation dietary questionnaire), and clinical data are extracted from electronic medical records. The study does not modify usual medical management and participation consists only in completing the questionnaires and receiving feedback on the results.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire and Physical Exam | Behavioral | Patients will be asked to complete questionnaires. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of severe diabetes-related distress (PAID-20 score ≥ 40) | Diabetes-related distress will be assessed using the Problem Areas In Diabetes scale (PAID-20). The PAID-20 includes 20 items scored from 0 to 4; the total raw score (0-80) is multiplied by 1.25 to obtain a total score ranging from 0 to 100, with higher scores indicating greater diabetes-related distress. Severe diabetes-related distress is defined as a PAID-20 total score ≥ 40. The primary endpoint is the proportion of participants with PAID-20 ≥ 40. | Baseline (single assessment during usual care visit, within 3 days from inclusion) |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of severe diabetes-related distress by care setting (ambulatory vs hospitalized) | Using the PAID-20 total score (0-100; higher scores indicate greater distress, severe distress defined as ≥ 40), the proportion of participants with severe diabetes-related distress will be calculated in two predefined subgroups: ambulatory patients (outpatient clinic and day hospital) and hospitalized patients (conventional hospitalization in endocrinology). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe CAROLI-BOSC, Dr | Contact | +33 4 92 03 21 87 | caroli-bosc.p@chu-nice.fr |
| Name | Affiliation | Role |
|---|---|---|
| Philippe CAROLI-BOSC, Dr | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nice | Recruiting | Nice | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline (single assessment during usual care visit, within 3 days from inclusion) |
| Factors associated with diabetes-related distress (PAID-20 score) | The PAID-20 total score (0-100; higher scores indicate greater diabetes-related distress) will be analysed as a continuous variable. Decision-tree models (CHAID/CRT) will be used to explore associations between diabetes-related distress and predefined clinical, psychosocial and lifestyle variables. | Baseline (single assessment during usual care visit, within 3 days from inclusion) |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
Not provided
Not provided