NCT04570813

Brief 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 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 18, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2021

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

11 months

First QC Date

September 22, 2020

Last Update Submit

April 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    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)

Study Arms (2)

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

Other: Artistic activies

No artistic activities

NO INTERVENTION

The control group is composed of participants who do not take part in art-based activities,

Interventions

12 workshops of artictic activities during 12 weeks

artistic activities

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Do not master the French language,
  • Person under guardianship, curatorship or safeguarding of justice,
  • Person unable to give or sign consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Mémoire de Ressources et de Recherche, CHU de Nice

Nice, 06000, France

Location

Related Publications (1)

  • 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.

Study Officials

  • Auriane GROS

    Research and Resources Memory Centre, Nice University Hospital, Nice, France

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 22, 2020

First Posted

September 30, 2020

Study Start

January 18, 2021

Primary Completion

December 23, 2021

Study Completion

December 23, 2021

Last Updated

April 26, 2022

Record last verified: 2022-04

Locations