Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (age ≥ 18 years).

Diagnosed with type 2 diabetes according to national (HAS) criteria, whether newly diagnosed or longstanding, with or without chronic complications, and with no restriction regarding HbA1c level. Managed for type 2 diabetes in the endocrinology department of Nice University Hospital (conventional hospitalization, day hospital, or outpatient consultation).

Able to understand the study information and to complete the self-administered questionnaires.

Affiliated to the French social security system.

Disqualifiers

Age < 18 years.

Pregnant woman.

Any type of diabetes other than type 2 diabetes (e.g. type 1 diabetes, secondary or genetic diabetes).

Haemochromatosis.

Trial design

Design model

Single group

Treatments tested in this trial

  • Questionnaire and Physical Exam

    Behavioral

    Patients will be asked to complete questionnaires.

Treatment groups

290 Participants
are divided into 1 treatment group
Group A: PatientsOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (single assessment during usual care visit, within 3 days from inclusion)

Secondary outcomes

1

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).

Time frame
Baseline (single assessment during usual care visit, within 3 days from inclusion)
2

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.

Time frame
Baseline (single assessment during usual care visit, within 3 days from inclusion)

Other outcomes

Sponsors and contacts

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