Social InteractionA-Health-RCTNCT03679715
A-Health RCT: Effects of Participatory Art-based Activity on Health of Older Community Dwellers
A study testing participatory art-based activity in people with Social Interaction and Quality of Life, run by Jewish General Hospital at 2 sites in 2 countries.
Trial summary
The overall objective of the study is to examine the effects of the Montreal Museum of Fine Arts (MMFA) participatory art-based activity on wellbeing, quality of life and health condition in older community dwellers. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Interaction, Quality of Life, Health, Subjective
- What is being tested?
- participatory art-based activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 5 Jan 2019to 1 Dec 2020
- 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
- Being 65 years and over
- Having an Internet access with an electronic device (i.e.; laptop, computer, smartphone, tablet) at the participant's place of living as the repetitive assessments for this study will be performed on the web platform of the Centre of Excellence on Longevity of McGill University
- Understanding and writing the language of the recruitment centre (i.e., French or English or Japanese)
- Life expectancy estimated over 3 months as the duration of the follow-up is 3 months
Who cannot join
- concomitant participation to another clinical trial,
- having participated to a participatory art-based activity of the museums,
- not speaking the language of the study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Effects of the Montreal Museum of Fine Arts Participatory Art-based Activity on Health of Older Community Dwellers: THE A-HEALTH RCT STUDY
The overall objective of the study is to examine the effects of the Montreal Museum of Fine Arts (MMFA) participatory art-based activity on wellbeing, quality of life and health condition in older community dwellers.
Aging is often associated with worsening health and withdrawal from social activities, both increasing the risk of a poor quality of life. It has been reported that the practice of art, especially participatory art-based activity enhances wellbeing, quality of life and health condition of patients and older adults. Since October 2015, the Montreal Museum of Fine Arts (MMFA; Quebec, Canada) has successfully initiated a participatory art-based activity known as "Les Beaux-Jeudis" for older community dwellers living in Montreal. Recently, the investigator demonstrated that the MMFA participatory art-based activity improved wellbeing, quality of life and health condition of Montreal older community dwellers using a pre-post single arm, prospective and longitudinal design: it was not a randomized controlled trial (RCT) which is the gold standard to examine the effects of an intervention.
Read the detailed description
Background. Recently, the investigator demonstrated that the Montreal Museum of Fine-Arts (MMFA) participatory art-based activity improved wellbeing, quality of life and health condition of Montreal older community dwellers using a pre-post single arm, prospective and longitudinal design. The main limitation of this pilot study was its design: it was not a randomized controlled trial (RCT) which is the gold standard to examine the effects of an intervention.
Objectives. The overall objective is to examine the effect of the MMFA participatory art-based activity on wellbeing, quality of life and health condition in older community dwellers.
The specific objectives are to compare the changes in 1) wellbeing, 2) quality of life and 3) health condition in older community dwellers participating in the museum participatory art-based activity (Intervention group) and in age and sex-matched older community dwellers who are not participants in the museum participatory art-based activity (Control group) during the same period of time. In addition, the compliance to museum participatory art-based activity in intervention will be examined. A second study, based on the same process, has been proceeded in Japan (Tokyo). With merging the 2 databases, we will study the impact of cultural specificities, comparing data collected in Montreal and data collected in Tokyo.
Methods. The design is a unicentre (Jewish General Hospital; Montreal, Quebec, Canada), clinical, randomized, controlled, single blinded (i.e.; investigators), superiority trial, with two parallel arms (Intervention and Control groups), comparative (comparison of Intervention and Control groups) and analyzed with the intention-to-treat.
The participants in the Intervention group will be participants of the museum participatory art-based activity. The Control group will be composed of older community dwellers matched on age and sex compared to the Intervention group but who will not be participate to the museum participatory art-based activity.
The follow-up period will be 3 months, which is the duration of a session of the museum participatory art-based activity. Assessment of wellbeing, quality of life and health condition will be performed at baseline, at the beginning of second and third months, and at the end of third month.
The same study has been developed and realized in Japan. Data collected in Canada will be merged with data collected in Japan and the analysis will be repeated for this international database.
- Conditions
- Social Interaction, Quality of Life, Health, Subjective
- Being tested
- participatory art-based activity
- Keywords
- Community-dwellers, older adults, museum, art
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
participatory art-based activityOther
The intervention is a participatory art-based activity which consists in making art in group, involving the participants directly in the creative process, allowing them to become co-authors of the work.
In Montreal, Canada, participants will meet once per week for a 2h workshop from 2.00 PM to 4.00 PM at the MMFA in a dedicated room during a three month-period defining "a session". Two successive sessions will be setup; a winter and a spring sessions. Each session will be composed of 12 consecutive workshops.
In Tokyo, Japan, participants will meet once per week for a 2h workshop at the Tokyo Fuji Museum in a dedicated room during a three month-period defining "a session". The session will be composed of 12 consecutive workshops.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The participants in the Intervention group will be participants of the museum participatory art-based activity. Receives: Other: participatory art-based activity |
| Control Group | No intervention | The Control arm will be composed of older community dwellers matched on age and sex compared to the Intervention group but who will not be participants at the museum participatory art-based activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health condition assessed by self-administered questionnaire (SAQ)
self-administered questionnaire (SAQ), score between 0 and 18, a higher score means a higher frailty
Measured: 3 months
Secondary outcomes (5)
Ability to use a computer assessed by Computer proficiency questionnaire self-questionnaire (CPQ)
Computer proficiency questionnaire self-questionnaire, self-estimation of different tasks on informatics devices quoted from Never tried to Very easily (high score for proficiency in informatics). Score for each categories is calculated from the mean of the sub-questions scored from 0 to 4
Measured: 1 day
Well-being assessed by Warwick-Edinburgh Mental Well-being Scale self-questionnaire
Warwick-Edinburgh Mental Well-being Scale self-questionnaire, quoting statement of feelings and thought from None of the Time to All of the time, scoring from 14 to 70 (high score for a good well-being)
Measured: 3 months
Quality of life of participants assessed by EuroQol-5D self-questionnaire
EuroQol-5D self-questionnaire, evaluating mobility, usual activities, self-care, pain, anxiety and mood, from No problem to Unable, scored from 5 to 25, High score meaning a bad quality of life
Measured: 3 months
Compliance assessed counting the number of workshops completed during the 3-month period of intervention.
assessed counting the number of workshops completed during the 3-months period of intervention.
Measured: 3 months
Satisfaction concerning the project assessed by self-questionnaire
self-questionnaire, qualitative (from 1 to 10: Dissatisfying to Satisfying), NO GLOBAL SCORE, each question is evaluated separately. A mean of all questions to have a global note (/10) will eventually be done for each participant.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start5 Jan 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Social InteractionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The design is a unicentre (Jewish General Hospital; Montreal, Quebec, Canada), clinical, randomized, controlled, single blinded (i.e.; investigators), superiority trial, with two parallel arms (Intervention and Control groups), comparative (comparison between Intervention and Control groups) and analyzed with the intention-to-treat.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Beauchet, Jewish General Hospital
- Investigators
- Olivier Beauchet, MD, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679715
- Sponsor's protocol ID
- 2019-1493
- Acronym
- A-Health-RCT
- Status last verified
- Feb 2021
- First submitted
- 18 Sep 2018
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cami M, Planta O, Matskiv J, Plonka A, Gros A, Beauchet O. Museum-based art activities to stay young at heart? Results of a randomized controlled trial. Front Med (Lausanne). 2024 Jan 5;10:1184040. doi: 10.3389/fmed.2023.1184040. eCollection 2023.
PubMed 38249982Hayashi Y, Matskiv J, Galery K, Beauchet O. Productive arts engagement at the Tokyo Fuji Art Museum and its health effects on the older Japanese population: results of a randomized controlled trial. Front Med (Lausanne). 2023 Jul 6;10:1188780. doi: 10.3389/fmed.2023.1188780. eCollection 2023.
PubMed 37484855Beauchet O, Cooper-Brown LA, Hayashi Y, Deveault M, Launay CP. Improving the mental and physical health of older community-dwellers with a museum participatory art-based activity: results of a multicentre randomized controlled trial. Aging Clin Exp Res. 2022 Jul;34(7):1645-1654. doi: 10.1007/s40520-022-02139-3. Epub 2022 May 17.
PubMed 35578103Beauchet O, Cooper-Brown L, Hayashi Y, Galery K, Vilcocq C, Bastien T. Effects of "Thursdays at the Museum" at the Montreal Museum of Fine Arts on the mental and physical health of older community dwellers: the art-health randomized clinical trial protocol. Trials. 2020 Aug 12;21(1):709. doi: 10.1186/s13063-020-04625-3.
PubMed 32787893
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Montreal Museum of Fine Arts Participatory Art-based Activity on Health of Older Community Dwellers: THE A-HEALTH RCT STUDY
- ClinicalTrials.gov ID
- NCT03679715
- Acronym / sponsor ID
- A-Health-RCT / 2019-1493
- Conditions
- Social Interaction, Quality of Life, Health, Subjective
- Keywords
- Community-dwellers, older adults, museum, art
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 20 Sep 2018 (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.
The overall objective of the study is to examine the effects of the Montreal Museum of Fine Arts (MMFA) participatory art-based activity on wellbeing, quality of life and health condition in older community dwellers.
Aging is often associated with worsening health and withdrawal from social activities, both increasing the risk of a poor quality of life. It has been reported that the practice of art, especially participatory art-based activity enhances wellbeing, quality of life and health condition of patients and older adults. Since October 2015, the Montreal Museum of Fine Arts (MMFA; Quebec, Canada) has successfully initiated a participatory art-based activity known as "Les Beaux-Jeudis" for older community dwellers living in Montreal. Recently, the investigator demonstrated that the MMFA participatory art-based activity improved wellbeing, quality of life and health condition of Montreal older community dwellers using a pre-post single arm, prospective and longitudinal design: it was not a randomized controlled trial (RCT) which is the gold standard to examine the effects of an intervention.
Detailed description
Background. Recently, the investigator demonstrated that the Montreal Museum of Fine-Arts (MMFA) participatory art-based activity improved wellbeing, quality of life and health condition of Montreal older community dwellers using a pre-post single arm, prospective and longitudinal design. The main limitation of this pilot study was its design: it was not a randomized controlled trial (RCT) which is the gold standard to examine the effects of an intervention.
Objectives. The overall objective is to examine the effect of the MMFA participatory art-based activity on wellbeing, quality of life and health condition in older community dwellers.
The specific objectives are to compare the changes in 1) wellbeing, 2) quality of life and 3) health condition in older community dwellers participating in the museum participatory art-based activity (Intervention group) and in age and sex-matched older community dwellers who are not participants in the museum participatory art-based activity (Control group) during the same period of time. In addition, the compliance to museum participatory art-based activity in intervention will be examined. A second study, based on the same process, has been proceeded in Japan (Tokyo). With merging the 2 databases, we will study the impact of cultural specificities, comparing data collected in Montreal and data collected in Tokyo.
Methods. The design is a unicentre (Jewish General Hospital; Montreal, Quebec, Canada), clinical, randomized, controlled, single blinded (i.e.; investigators), superiority trial, with two parallel arms (Intervention and Control groups), comparative (comparison of Intervention and Control groups) and analyzed with the intention-to-treat.
The participants in the Intervention group will be participants of the museum participatory art-based activity. The Control group will be composed of older community dwellers matched on age and sex compared to the Intervention group but who will not be participate to the museum participatory art-based activity.
The follow-up period will be 3 months, which is the duration of a session of the museum participatory art-based activity. Assessment of wellbeing, quality of life and health condition will be performed at baseline, at the beginning of second and third months, and at the end of third month.
The same study has been developed and realized in Japan. Data collected in Canada will be merged with data collected in Japan and the analysis will be repeated for this international database.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The design is a unicentre (Jewish General Hospital; Montreal, Quebec, Canada), clinical, randomized, controlled, single blinded (i.e.; investigators), superiority trial, with two parallel arms (Intervention and Control groups), comparative (comparison between Intervention and Control groups) and analyzed with the intention-to-treat.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: participatory art-based activityThe participants in the Intervention group will be participants of the museum participatory art-based activity. |
| Control Group | No intervention | –The Control arm will be composed of older community dwellers matched on age and sex compared to the Intervention group but who will not be participants at the museum participatory art-based activity. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Being 65 years and over
- Having an Internet access with an electronic device (i.e.; laptop, computer, smartphone, tablet) at the participant's place of living as the repetitive assessments for this study will be performed on the web platform of the Centre of Excellence on Longevity of McGill University
- Understanding and writing the language of the recruitment centre (i.e., French or English or Japanese)
- Life expectancy estimated over 3 months as the duration of the follow-up is 3 months
Key exclusion criteria (3 listed)
- concomitant participation to another clinical trial,
- having participated to a participatory art-based activity of the museums,
- not speaking the language of the study.
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 |
|---|---|---|
| participatory art-based activityThe intervention is a participatory art-based activity which consists in making art in group, involving the participants directly in the creative process, allowing them to become co-authors of the work. In Montreal, Canada, participants will meet once per week for a 2h workshop from 2.00 PM to 4.00 PM at the MMFA in a dedicated room during a three month-period defining "a session". Two successive sessions will be setup; a winter and a spring sessions. Each session will be composed of 12 consecutive workshops. In Tokyo, Japan, participants will meet once per week for a 2h workshop at the Tokyo Fuji Museum in a dedicated room during a three month-period defining "a session". The session will be composed of 12 consecutive workshops. | Other | Intervention group |
Primary outcome
Health condition assessed by self-administered questionnaire (SAQ)
Time frame: 3 months
self-administered questionnaire (SAQ), score between 0 and 18, a higher score means a higher frailty
5 secondary outcomes
Ability to use a computer assessed by Computer proficiency questionnaire self-questionnaire (CPQ)
Time frame: 1 day
Well-being assessed by Warwick-Edinburgh Mental Well-being Scale self-questionnaire
Time frame: 3 months
Quality of life of participants assessed by EuroQol-5D self-questionnaire
Time frame: 3 months
Compliance assessed counting the number of workshops completed during the 3-month period of intervention.
Time frame: 3 months
Satisfaction concerning the project assessed by self-questionnaire
Time frame: 1 day
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 9 Feb 2021.
- Derived from this study: PubMed 38249982Cami M, Planta O, Matskiv J, Plonka A, Gros A, Beauchet O. Museum-based art activities to stay young at heart? Results of a randomized controlled trial. Front Med (Lausanne). 2024 Jan 5;10:1184040. doi: 10.3389/fmed.2023.1184040. eCollection 2023.
- Derived from this study: PubMed 37484855Hayashi Y, Matskiv J, Galery K, Beauchet O. Productive arts engagement at the Tokyo Fuji Art Museum and its health effects on the older Japanese population: results of a randomized controlled trial. Front Med (Lausanne). 2023 Jul 6;10:1188780. doi: 10.3389/fmed.2023.1188780. eCollection 2023.
- Derived from this study: PubMed 35578103Beauchet O, Cooper-Brown LA, Hayashi Y, Deveault M, Launay CP. Improving the mental and physical health of older community-dwellers with a museum participatory art-based activity: results of a multicentre randomized controlled trial. Aging Clin Exp Res. 2022 Jul;34(7):1645-1654. doi: 10.1007/s40520-022-02139-3. Epub 2022 May 17.
- Derived from this study: PubMed 32787893Beauchet O, Cooper-Brown L, Hayashi Y, Galery K, Vilcocq C, Bastien T. Effects of "Thursdays at the Museum" at the Montreal Museum of Fine Arts on the mental and physical health of older community dwellers: the art-health randomized clinical trial protocol. Trials. 2020 Aug 12;21(1):709. doi: 10.1186/s13063-020-04625-3.
- Individual participant dataSharing planned: No
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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.
Olivier Beauchet, MD principal investigator
Jewish General Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing participatory art-based activity in people with Social Interaction and Quality of Life, run by Jewish General Hospital at 2 sites in 2 countries.
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 4 inclusion and 3 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 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Japan. 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?
Health condition assessed by self-administered questionnaire (SAQ) (time frame: 3 months). 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 NCT03679715, which also lists 4 linked publications.
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 9 Feb 2021.