Does Diabetes Related Distress Impact on Balance Glycemic ? (DDS)

August 25, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

Detailed Description

The health consequences of emotional problems are associated with poor self-care behaviour, poor metabolic outcomes (HbA1c) and reduced quality of life. If quarterly glycated haemoglobin (HbA1c) testing is the gold standard for monitoring the risk of diabetes complications, should it not be systematically combined with the assessment of distress related to living with diabetes? To our knowledge, there are few studies in France that have correlated glycaemic control with a scale assessing the emotional stress factors associated with diabetes.

The main objective is to evaluate diabetes-related distress in adult patients with diabetes during their hospitalization in a diabetes ward, using a self-assessment instrument: the Diabetes Distress Scale (DDS-17).

The secondary objective is to assess the correlation between the overall diabetes distress score and the patient's glycosylated haemoglobin.

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75013
        • Diabetology department - Hospital of Pitié Salpêtrière - APHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All adult hospitalized patients for diabetes at IE3M.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall diabetes distress score
Time Frame: at baseline

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: at baseline
The patient's glycated haemoglobin (Hba1c) result, expressed as a %, taken during the standard check-up on the day of admission to hospital.
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Evelyne Alvitre, Nursing degree, Diabetology department - Hospital of Pitié Salpêtrière

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2023

Primary Completion (Actual)

May 30, 2023

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP230419
  • 2023-A00342-43 (Registry Identifier: IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe