- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04570813
Art'Health: Effects of Artistic and Participative Workshops at the MAMAC of Nice on the Health of Seniors (Art'Health)
April 19, 2022 updated by: Centre Hospitalier Universitaire de Nice
Study with two arms, one of which receives an intervention in the form of participative artistic workshops at the MAMAC and the other was assigned as the control group.
Well-being, Quality of life, Health, Apathy and Olfactory identification scales are proposed before the intervention, during the intervention at the end of each month (M1, M2, M3), 6 months after the end of the intervention (M9) and 12 months after the end of the intervention (M15).
Study Overview
Study Type
Interventional
Enrollment (Actual)
127
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
-
-
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Nice, France, 06000
- Centre Mémoire de Ressources et de Recherche, CHU de Nice
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-
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
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be 65 years of age at the time of signing the consent,
- Having internet access and an electronic tool (smartphone and/or tablet) at home as repeated assessments will be proposed on a dedicated and secure internet platform,
- To master the French language,
- To be available during participatory workshop sessions at MAMAC.
- Be affiliated to Social Security
Exclusion Criteria:
- Do not master the French language,
- Severe sensory and/or cognitive impairment identified by the IP and their representatives during the inclusion interview,
- Person under guardianship, curatorship or safeguarding of justice,
- Person unable to give or sign consent.
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: artistic activities
participants will do a 3-month cycle of weekly "artistic activities" at the MAMAC Museum," which are structured 2-h-long art-based workshops
|
12 workshops of artictic activities during 12 weeks
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No Intervention: No artistic activities
The control group is composed of participants who do not take part in art-based activities,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes of well being level
Time Frame: before the intervention, during the intervention at the end of each month (Month1, Month 2, Month 3), 6 months after the end of the intervention (Month 9) and 12 months after the end of the intervention (Month 15)
|
well being scale assessment Warwick-Edimbourg Mental Well-Being State (WEMWBS) maximum value : 70 (better outcome) minimum value :14 (worse outcome) |
before the intervention, during the intervention at the end of each month (Month1, Month 2, Month 3), 6 months after the end of the intervention (Month 9) and 12 months after the end of the intervention (Month 15)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Auriane GROS, Research and Resources Memory Centre, Nice University Hospital, Nice, France
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 (Actual)
January 18, 2021
Primary Completion (Actual)
December 23, 2021
Study Completion (Actual)
December 23, 2021
Study Registration Dates
First Submitted
September 22, 2020
First Submitted That Met QC Criteria
September 25, 2020
First Posted (Actual)
September 30, 2020
Study Record Updates
Last Update Posted (Actual)
April 26, 2022
Last Update Submitted That Met QC Criteria
April 19, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 20-PP-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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