Quality of Life Clinical Trial
— EDUCARTPED| NCT number | NCT02797730 |
| Other study ID # | EDUCARTPED |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 2016 |
| Est. completion date | August 2016 |
| Verified date | April 2020 |
| Source | Poitiers University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | August 2016 |
| Est. primary completion date | August 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | La rochelle | La rochelle | |
| France | NIORT | Niort | |
| France | POITIERS | Poitiers |
| Lead Sponsor | Collaborator |
|---|---|
| Poitiers University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | PedsQL Family Impact score to assess Family Quality of Life | 6 weeks | ||
| Secondary | Anxiety score of caregivers | 6 weeks | ||
| Secondary | self esteem score of caregivers | 6 weeks | ||
| Secondary | quality of life score | 6 weeks | ||
| Secondary | satisfaction score | 12 weeks |
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