Does Diabetes Related Distress Impact on Balance Glycemic ?

NCT05831384 | Completed

• 2 other identifiers: APHP2304192023-A00342-43
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective is to assess the overall diabetes distress score in adult patients with diabetes during their hospitalization in a diabetes ward, using the Diabetes Distress Scale (DDS-17). The correlation between the overall diabetes distress score and the patient's glycosylated haemoglobin will then be assessed.

Conditions

Diabetes

Keywords

Diabetes; Distress

Outcome Measures

Primary Outcomes (1)

• Overall diabetes distress score

  The primary endpoint is the overall diabetes distress score obtained by the DDS-17 psychometric tool. Each item is rated on a 6-point scale ranging from (1) "not a problem" to (6) "a very significant problem". Each of the 17 criteria of the DDS17 is rated on a 6-point scale ranging from (1) "not a problem" to (6) "a very important problem". The scale gives an overall distress score based on the average responses on the 1-6 scale for the 17 items. Interpretation of the DDS 17 total scores: * Mean score \< 2.0 = reflects little or no distress * Mean score between 2.0 and 2.9 = reflects moderate distress * Mean score \> 3.0 = reflects high distress.

  at baseline

Secondary Outcomes (1)

• The The patient's glycated haemoglobin (Hba1c) result, expressed as a %, taken during the standard check-up on the day of admission to hospital result (Hba1c)

  at baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult hospitalized patients for diabetes at IE3M.

You may qualify if:

• Patients living with type 1 or type 2 diabetes.
• Patients hospitalised in the diabetes department of the IE3M.
• Patients aged ⩾ 18 years.
• Patients agreeing to participate in this study after information.
• Beneficiary of the health insurance.

You may not qualify if:

• Refusal to participate.
• Inability to communicate in French.
• Inability to read or write French.
• Communication disorders.
• History of psychiatric disorders, dementia.
• Patient under guardianship or curatorship.
• Patient not affiliated to social security.
• Patient affiliated to the Aide Médicale d'Etat (AME).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Diabetology department - Hospital of Pitié Salpêtrière - APHP

Paris, 75013, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sampling

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Evelyne Alvitre, Nursing degree

  Diabetology department - Hospital of Pitié Salpêtrière

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 26, 2023
• Study Start: May 11, 2023
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Locations

FR (1)