Clinical trial NCT05292703: Olfaction, Virtual Reality and Art in Health
Official title: Olfaction, Virtual Reality and Art in Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly People
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 51
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

Detailed description: Health is defined by WHO as a condition of mental, physical and social well-being. Cognitive aging markers have been defined such as apathy and deterioration of olfactory identification. Artistic creation can be used to improve health, and olfactory stimulation can improve olfactory abilities.

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).

Concerning the categorical variables, the frequencies will be calculated. First the basic characteristics (age, sex, etc.) will be described and compared for each group (i.e., intervention versus control) using parametric and non-parametric tests according to the distribution of variables. Regarding the quantitative variables, the distribution will be studied (mean, median, mode, minimum, maximum, confidence interval around the mean, standard deviation). The statistical tests used will be unpaired T-tests or Mann-Whitney U-tests to compare the two appropriate groups depending on the groups.

Several effects are expected following the practice of participatory artistic workshops. First, an improvement in well-being is expected, measured by the WEMBS scale. An immediate and medium-term benefit is expected, which will be measured 3 months after the end of the workshops. In a second step, an improvement in the Quality of Life and the state of Health is expected. Measurement data for early markers of cognitive decline, Apathy and Olfactory identification should improve. In the long term and more generally, the validation of the proposed study could make it possible to legitimately ensure its dissemination on a larger scale, and to strengthen the involvement of seniors with public users in participatory artistic programs in person or remotely, in order to ensure them a quality ageing. The data will be compared a posteriori with international data in order to compare the effects of artistic workshops in person or remotely. An acceptability questionnaire will assess the adherence of seniors to a distance and virtual artistic program before and after use.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Not fluent in french language,
* Present sensory and/or cognitive deterioration identified by the investigator during inclusion,
* Being under guardianship or curatorship or safeguard of justice,
* Being unable to give or sign consent

Primary outcomes:
measure: change in Warwick-Edinburgh Mental Well-Being Scale (WEMBS)
timeFrame: At the beginning, after the session and 3 months after the end of the session
Secondary outcomes:
measure: Quality of life scale (EQ5D)
timeFrame: At the beginning, after the session and 3 months after the end of the session
measure: Health scale (CESAM)
timeFrame: At the beginning, after the session and 3 months after the end of the session
measure: Apathy scale (b-DAS)
timeFrame: At the beginning, after the session and 3 months after the end of the session
measure: User experience evaluation questionnaire (Usability Evaluation)
timeFrame: After the session and 3 months after the end of the session
measure: Olfactory identification test (Bellecôte)
timeFrame: At the beginning, after the session et 3 months after the end of the session
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice Centre Mémoire
Study officials:
affiliation: CMRR
name: AURIANE GROS, SPEECH THERAPIST
role: PRINCIPAL_INVESTIGATOR
References: