NCT05292703

Brief Summary

The main objective of this study is to compare the well-being of a group of seniors participating for a month in face-to-face sessions of artistic and olfactory activities with another group of seniors performing the same type of activity for a month but remotely with connection to a dedicated application. Well-being, Quality of Life, Health, Apathy and Olfactory identification scales are proposed before the intervention, at the end of the intervention (V0, V1), then 3 months after the end of the intervention. A Usability Evaluation questionnaire will be sent to the participants of the remote group after use (V1).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

October 6, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2023

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

March 1, 2022

Last Update Submit

March 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • change in Warwick-Edinburgh Mental Well-Being Scale (WEMBS)

    The 14-item scale WEMWBS has 5 response categories, summed to provide a single score. The items are all worded positively and cover both feeling and functioning aspects of mental wellbeing, thereby making the concept more accessible.

    At the beginning, after the session and 3 months after the end of the session

Secondary Outcomes (5)

  • Quality of life scale (EQ5D)

    At the beginning, after the session and 3 months after the end of the session

  • Health scale (CESAM)

    At the beginning, after the session and 3 months after the end of the session

  • Apathy scale (b-DAS)

    At the beginning, after the session and 3 months after the end of the session

  • User experience evaluation questionnaire (Usability Evaluation)

    After the session and 3 months after the end of the session

  • Olfactory identification test (Bellecôte)

    At the beginning, after the session et 3 months after the end of the session

Study Arms (2)

face-to-face group

EXPERIMENTAL

In the face-to-face group, the intervention is a participatory activity based on art and olfactory stimulation which consists of practicing art in a group under supervision, involving the participants directly in the creative process, allowing them to become co-authors. Participants will meet once a week for 4 weeks for a 2-hour workshop at the Institut Claude Pompidou in Nice in a dedicated space, adapted to health circumstances and respecting social distancing measures. Due to the health crisis, the workshops will be offered in several groups ranging from 8 to 10 participants, these groups will be equal. A different theme will be offered each week. Each workshop will be led by the same artist who will propose creative activities to be carried out by the participants and each session will result in a creation that the participant will take away, bringing into play artistic skills and olfactory identification capacities

Other: Participatory activity based on art and olfactory stimulation

remote group

EXPERIMENTAL

For the remote group, immediately after randomization, they will receive the connection link to the internet application and an individual connection code. The intervention is a participative activity based on art and olfactory stimulation which consists of practicing art virtually in conjunction with olfactory identification by following a dedicated program developed in partnership with the same artist involved in the workshops in presence, so that the virtual activities are very similar to those of the face-to-face workshop. The artistic workshops will take place according to 4 themes with a different theme per week. Each workshop end with an original artistic creation received by email, bringing into play artistic skills and olfactory identification capacities. Each participant will connect once a week at their convenience during 4 weeks.

Other: practicing art virtually in conjunction with olfactory identification

Interventions

practicing art in a group under supervision, involving the participants directly in the creative process, allowing them to become co-authors. Participants will meet once a week for 4 weeks for a 2-hour workshop at the Institut Claude Pompidou in Nice in a dedicated space, A different theme will be offered each week. Each workshop will be led by the same artist who will propose creative activities to be carried out by the participants and each session will result in a creation that the participant will take away, bringing into play artistic skills and olfactory identification capacities.

face-to-face group

For the remote group, , they will receive the connection link to the internet application and an individual connection code. The intervention is a participative activity based on art and olfactory stimulation which consists of practicing art virtually in conjunction with olfactory identification by following a dedicated program developed in partnership with the same artist involved in the workshops in presence, so that the virtual activities are very similar to those of the face-to-face workshop. The artistic workshops will take place according to 4 themes with a different theme per week. Each workshop end with an original artistic creation received by email, bringing into play artistic skills and olfactory identification capacities. Each participant will connect once a week at their convenience during 4 weeks.

remote group

Eligibility Criteria

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

You may qualify if:

  • aged 65 or more
  • Get internet access and an electronic tool such as a smartphone or tablet,
  • Be fluent in French language.
  • Be available during participatory artistic workshop sessions.
  • Be affiliated with Social Security

You may not qualify if:

  • Not fluent in french language,
  • Being under guardianship or curatorship or safeguard of justice,
  • Being unable to give or sign consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice Centre Mémoire

Nice, France

Location

Study Officials

  • AURIANE GROS, SPEECH THERAPIST

    CMRR

    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

March 1, 2022

First Posted

March 23, 2022

Study Start

October 6, 2022

Primary Completion

March 21, 2023

Study Completion

March 21, 2023

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations