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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02797730
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : October 12, 2016
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Quality of Life Behavioral: art-therapy sessions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : May 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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



Primary Outcome Measures :
  1. PedsQL Family Impact score to assess Family Quality of Life [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Anxiety score of caregivers [ Time Frame: 6 weeks ]
  2. self esteem score of caregivers [ Time Frame: 6 weeks ]
  3. quality of life score [ Time Frame: 6 weeks ]
  4. satisfaction score [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797730


Locations
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France
La rochelle
La rochelle, France, 17 000
NIORT
Niort, France, 79000
POITIERS
Poitiers, France
Sponsors and Collaborators
Poitiers University Hospital

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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT02797730     History of Changes
Other Study ID Numbers: EDUCARTPED
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: June 2016

Keywords provided by Poitiers University Hospital:
Art Therapy
Caregiver's