Well AgingArt'HealthNCT04570813
Art'Health: Effects of Artistic and Participative Workshops at the MAMAC of Nice on the Health of Seniors
A study testing Artistic activies in people with Well Aging, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well Aging
- What is being tested?
- Artistic activies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2021to 23 Dec 2021
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Mémoire de Ressources et de Recherche, CHU de Nice
Nice, 06000
About this study
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).
- Conditions
- Well Aging
- Being tested
- Artistic activies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artistic activiesOther
12 workshops of artictic activities during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| artistic activities | Experimental | participants will do a 3-month cycle of weekly "artistic activities" at the MAMAC Museum," which are structured 2-h-long art-based workshops Receives: Other: Artistic activies |
| No artistic activities | No intervention | The control group is composed of participants who do not take part in art-based activities, |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of well being level
well being scale assessment Warwick-Edimbourg Mental Well-Being State (WEMWBS)
maximum value : 70 (better outcome) minimum value :14 (worse outcome)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start18 Jan 2021
- Primary completion23 Dec 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Well AgingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Auriane GROS, Principal investigator, Research and Resources Memory Centre, Nice University Hospital, Nice, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570813
- Sponsor's protocol ID
- 20-PP-21
- Acronym
- Art'Health
- Status last verified
- Apr 2022
- First submitted
- 22 Sep 2020
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Payne M, Galery K, Plonka A, Lemaire J, Derreumaux A, Fabre R, Mouton A, Sacco G, Guerin O, Manera V, Robert P, Beauchet O, Gros A. Productive art engagement in a hybrid format: effects on emotions of older adults during COVID-19 pandemic. Front Public Health. 2024 Jan 26;12:1257411. doi: 10.3389/fpubh.2024.1257411. eCollection 2024.
PubMed 38344232
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Art'Health: Effects of Artistic and Participative Workshops at the MAMAC of Nice on the Health of Seniors
- ClinicalTrials.gov ID
- NCT04570813
- Acronym / sponsor ID
- Art'Health / 20-PP-21
- Conditions
- Well Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 30 Sep 2020 (actual)
- 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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| artistic activities | Experimental | Other: Artistic activiesparticipants will do a 3-month cycle of weekly "artistic activities" at the MAMAC Museum," which are structured 2-h-long art-based workshops |
| No artistic activities | No intervention | –The control group is composed of participants who do not take part in art-based activities, |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Artistic activies12 workshops of artictic activities during 12 weeks | Other | artistic activities |
Primary outcome
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)
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 26 Apr 2022.
- Derived from this study: PubMed 38344232Payne M, Galery K, Plonka A, Lemaire J, Derreumaux A, Fabre R, Mouton A, Sacco G, Guerin O, Manera V, Robert P, Beauchet O, Gros A. Productive art engagement in a hybrid format: effects on emotions of older adults during COVID-19 pandemic. Front Public Health. 2024 Jan 26;12:1257411. doi: 10.3389/fpubh.2024.1257411. eCollection 2024.
- Individual participant dataSharing planned: Undecided
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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.
Auriane GROS principal investigator
Research and Resources Memory Centre, Nice University Hospital, Nice, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artistic activies in people with Well Aging, run by Centre Hospitalier Universitaire de Nice at 1 site 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 5 inclusion and 4 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 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04570813, which also lists 1 linked publication.
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 26 Apr 2022.