Quality of LifeEDUCARTPEDNCT02797730
Study of Impact of Art Therapy Sessions Given to Family Caregivers of Children With Type 1 Diabetes
A study testing art-therapy sessions in people with Quality of Life, run by Poitiers University Hospital at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- art-therapy sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesFrance
- Study dates
- May 2016to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- other research participation
- < 18 years
- host family
- with protection of vulnerable adult
- caregivers of child with who have not insurance
Trial locations and contacts
3 sites in 1 country.
France3 sites
La rochelle
La Rochelle, 17 000
NIORT
Niort, 79000
POITIERS
Poitiers
About this study
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
- Conditions
- Quality of Life
- Being tested
- art-therapy sessions
- Keywords
- Art Therapy, Caregiver's
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
art-therapy sessionsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| art-therapy sessions | Experimental | Caregivers will receive 6 art-therapy sessions Receives: Behavioral: art-therapy sessions |
| no art-therapy sessions | No intervention | Caregivers will not receive 6 art-therapy sessions during the evaluation period |
What is being measured
The primary outcome is the main question the study is designed to answer.
PedsQL Family Impact score to assess Family Quality of Life
Measured: 6 weeks
Secondary outcomes (4)
Anxiety score of caregivers
Measured: 6 weeks
self esteem score of caregivers
Measured: 6 weeks
quality of life score
Measured: 6 weeks
satisfaction score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797730
- Sponsor's protocol ID
- EDUCARTPED
- Acronym
- EDUCARTPED
- Status last verified
- Apr 2020
- First submitted
- 20 May 2016
- Last updated
- 14 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Impact of Art Therapy Sessions Given to Family Caregivers of Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02797730
- Acronym / sponsor ID
- EDUCARTPED / EDUCARTPED
- Conditions
- Quality of Life
- Keywords
- Art Therapy, Caregiver's
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 13 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| art-therapy sessions | Experimental | Behavioral: art-therapy sessionsCaregivers will receive 6 art-therapy sessions |
| no art-therapy sessions | No intervention | –Caregivers will not receive 6 art-therapy sessions during the evaluation period |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- other research participation
- < 18 years
- host family
- with protection of vulnerable adult
- caregivers of child with who have not insurance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| art-therapy sessions | Behavioural | art-therapy sessions |
Primary outcome
PedsQL Family Impact score to assess Family Quality of Life
Time frame: 6 weeks
4 secondary outcomes
Anxiety score of caregivers
Time frame: 6 weeks
self esteem score of caregivers
Time frame: 6 weeks
quality of life score
Time frame: 6 weeks
satisfaction score
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing art-therapy sessions in people with Quality of Life, run by Poitiers University Hospital at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PedsQL Family Impact score to assess Family Quality of Life (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.