Study of Impact of Art Therapy Sessions Given to Family Caregivers of Children With Type 1 Diabetes (EDUCARTPED)

April 10, 2020 updated by: Poitiers University Hospital

Diagnostic of diabetes in childhood brought modification of family way of life, particularly in child and caregivers lifes.

The education patient programs are in France centered on curative competencies of care.

It is possible that art-therapy improve psycho-social competencies The aim of the study is to evaluate art-therapy sessions on quality of life of caregivers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • La rochelle, France, 17 000
        • La Rochelle
      • Niort, France, 79000
        • NIORT
      • Poitiers, France
        • Poitiers

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • one of the family caregivers of child with diabetes enrolled in patient education programs of 3 hospitals (Hospital of Poitiers, Hospital of Niort and Hospital of La Rochelle)
  • who accept the study
  • ≥ 18 years
  • free, with protection of vulnerable adult
  • caregivers of child with who have insurance
  • with free, enlightened, signed consent

Exclusion Criteria:

  • other research participation
  • < 18 years
  • host family
  • with protection of vulnerable adult
  • caregivers of child with who have not insurance

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: art-therapy sessions
Caregivers will receive 6 art-therapy sessions
Behavioral: art-therapy sessions
No Intervention: no art-therapy sessions
Caregivers will not receive 6 art-therapy sessions during the evaluation period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PedsQL Family Impact score to assess Family Quality of Life
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Anxiety score of caregivers
Time Frame: 6 weeks
6 weeks
self esteem score of caregivers
Time Frame: 6 weeks
6 weeks
quality of life score
Time Frame: 6 weeks
6 weeks
satisfaction score
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Sponsor

Poitiers University Hospital

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

May 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

May 20, 2016

First Submitted That Met QC Criteria

June 8, 2016

First Posted (Estimate)

June 13, 2016

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 10, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EDUCARTPED

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.

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