NCT02797730

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable quality-of-life

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable quality-of-life

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

May 20, 2016

Last Update Submit

April 10, 2020

Conditions

Quality of Life

Keywords

Art TherapyCaregiver's

Outcome Measures

Primary Outcomes (1)

  • PedsQL Family Impact score to assess Family Quality of Life

    6 weeks

Secondary Outcomes (4)

  • Anxiety score of caregivers

    6 weeks

  • self esteem score of caregivers

    6 weeks

  • quality of life score

    6 weeks

  • satisfaction score

    12 weeks

Study Arms (2)

art-therapy sessions

EXPERIMENTAL

Caregivers will receive 6 art-therapy sessions

Behavioral: art-therapy sessions

no art-therapy sessions

NO INTERVENTION

Caregivers will not receive 6 art-therapy sessions during the evaluation period

Interventions

art-therapy sessionsBEHAVIORAL
art-therapy sessions

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

La rochelle

La Rochelle, 17 000, France

Location

NIORT

Niort, 79000, France

Location

POITIERS

Poitiers, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2016

First Posted

June 13, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

April 14, 2020

Record last verified: 2020-04

Locations

FR(3)