Atrial Fibrillation RecurrentHeART-BRAINNCT06130358
Investigating the Effects of a Museum Intervention on the Psychological and Cardiac Health of Older Adults
A study testing Experimental: Well-being intervention followed by classic intervention and Experimental: Classic intervention followed by well-being intervention in people with Atrial Fibrillation Recurrent and Aging, run by Louis Bherer at 1 site in Canada.
Trial summary
In a recent report, the World Organization for Health provided some evidence that artistic and cultural activities can support the health and well-being of the population. Our previous research suggests that the effect of museum visits on well-being and stress might be tied to relaxing proprieties of contact with art… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation Recurrent, Aging
- What is being tested?
- Experimental: Well-being intervention followed by classic intervention and Experimental: Classic intervention followed by well-being intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2024to 1 Feb 2025
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men/women aged 50 and over,
- Presenting normal or corrected vision and hearing,
- With or without controlled Atrial fibrillation,
- No specific expertise in visual arts (official degree or training relating to the visual arts),
- Occasionally attended museums and exhibitions (≤ 6 times per year).
Who cannot join
- Score > 5/15 on the geriatric depression scale,
- Score on the telephone version of the MMSE < 19,
- Psychiatric or neurological diagnosis,
- Presence of major functional limitations likely to affect the individual's ability to stand and walk independently.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
Montreal, Quebec, H1T1N6
About this study
Official title: HeART-BRAIN : Investigating the Effects of a Museum Intervention on the Psychological and Cardiac Health of Older Adults With and Without Atrial Fibrillation
In a recent report, the World Organization for Health provided some evidence that artistic and cultural activities can support the health and well-being of the population. Our previous research suggests that the effect of museum visits on well-being and stress might be tied to relaxing proprieties of contact with art objects, especially when the artwork is viewed with an introspective and self-reflexive approach. This study addresses the effect of a well-being museum intervention of six weeks on cerebral activity associated with artwork contemplation during a museum visit and assesses how it affects the psychological and cardiovascular health of older adults with and without atrial fibrillation. The well-being intervention will engage the participant in a series of 6 visits, in groups of 10, oriented on his feelings, impressions, and interpretations of artworks. This well-being museum intervention will be compared to visits typically provided in the museum, in a cross-over single-blinded design.
- Conditions
- Atrial Fibrillation Recurrent, Aging
- Being tested
- Experimental: Well-being intervention followed by classic intervention, Experimental: Classic intervention followed by well-being intervention
- Keywords
- Museum visits, Neurocognition, Stress, Cardiovascular functioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Well-being intervention followed by classic interventionOther
2 x 6 weeks of weekly museum visits
Experimental: Classic intervention followed by well-being interventionOther
2 x 6 weeks of weekly museum visits
| Study group | Role | What they receive |
|---|---|---|
| Well-Being Museum intervention | Experimental | The well-being intervention comprises six weeks of weekly museum visits, performed in groups of 10 participants. The well-being approach is based on the support of a museum mediator. His role is to help visitors to develop a more personal and sensitive understanding of artworks. To do this, he encourages the expression of feelings, impressions, and interpretations of the artwork, and supports exchanges within the group of visitors. With the mediator's support, the participants should be able to adopt a more subjective approach to the artwork, favoring their engagement when contemplating it. Receives: Other: Experimental: Well-being intervention followed by classic intervention; Other: Experimental: Classic intervention followed by well-being intervention |
| Classic Museum intervention | Active comparator | The classic intervention comprises six weeks of weekly museum visits, performed in groups of 10 participants. The classic museum session will be performed according to what is typically provided to visitors as part of a guided visit to the museum. Each visit will be accompanied by a volunteer guide trained in art history. He will guide participants across artworks and provide information about art pieces, the artist, and the historical context. The volunteer guide will provide context and informative content about the artwork without intending to influence the discussions and the visitor's apprehension of the artwork. Receives: Other: Experimental: Well-being intervention followed by classic intervention; Other: Experimental: Classic intervention followed by well-being intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the activity evoked within the ventrolateral prefrontal cortex during the contemplation of artwork
Hemodynamic variations in the region of interest (concentration of oxygenated hemoglobin [HbO2], no units).
Measured: Before and after the 6 weeks of interventions
Secondary outcomes (1)
Change in the activity evoked within the medial prefrontal cortex during the contemplation of artwork
Hemodynamic variations in the region of interest (concentration of oxygenated hemoglobin [HbO2], no units).
Measured: Before and after the 6 weeks of interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start1 Feb 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation RecurrentStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louis Bherer
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, Université de Montréal, Mitacs
- Responsible party
- Sponsor-investigator, Louis Bherer, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130358
- Sponsor's protocol ID
- ICM 2024-3325
- Acronym
- HeART-BRAIN
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HeART-BRAIN : Investigating the Effects of a Museum Intervention on the Psychological and Cardiac Health of Older Adults With and Without Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06130358
- Acronym / sponsor ID
- HeART-BRAIN / ICM 2024-3325
- Conditions
- Atrial Fibrillation Recurrent, Aging
- Keywords
- Museum visits, Neurocognition, Stress, Cardiovascular functioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Louis BhererUniversity, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, Université de Montréal, Mitacs
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 14 Nov 2023 (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.
In a recent report, the World Organization for Health provided some evidence that artistic and cultural activities can support the health and well-being of the population. Our previous research suggests that the effect of museum visits on well-being and stress might be tied to relaxing proprieties of contact with art objects, especially when the artwork is viewed with an introspective and self-reflexive approach. This study addresses the effect of a well-being museum intervention of six weeks on cerebral activity associated with artwork contemplation during a museum visit and assesses how it affects the psychological and cardiovascular health of older adults with and without atrial fibrillation. The well-being intervention will engage the participant in a series of 6 visits, in groups of 10, oriented on his feelings, impressions, and interpretations of artworks. This well-being museum intervention will be compared to visits typically provided in the museum, in a cross-over single-blinded design.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Well-Being Museum intervention | Experimental | Other: Experimental: Well-being intervention followed by classic intervention, Other: Experimental: Classic intervention followed by well-being interventionThe well-being intervention comprises six weeks of weekly museum visits, performed in groups of 10 participants. The well-being approach is based on the support of a museum mediator. His role is to help visitors to develop a more personal and sensitive understanding of artworks. To do this, he encourages the expression of feelings, impressions, and interpretations of the artwork, and supports exchanges within the group of visitors. With the mediator's support, the participants should be able to adopt a more subjective approach to the artwork, favoring their engagement when contemplating it. |
| Classic Museum intervention | Active comparator | Other: Experimental: Well-being intervention followed by classic intervention, Other: Experimental: Classic intervention followed by well-being interventionThe classic intervention comprises six weeks of weekly museum visits, performed in groups of 10 participants. The classic museum session will be performed according to what is typically provided to visitors as part of a guided visit to the museum. Each visit will be accompanied by a volunteer guide trained in art history. He will guide participants across artworks and provide information about art pieces, the artist, and the historical context. The volunteer guide will provide context and informative content about the artwork without intending to influence the discussions and the visitor's apprehension of the artwork. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men/women aged 50 and over,
- Presenting normal or corrected vision and hearing,
- With or without controlled Atrial fibrillation,
- No specific expertise in visual arts (official degree or training relating to the visual arts),
- Occasionally attended museums and exhibitions (≤ 6 times per year).
Key exclusion criteria (4 listed)
- Score > 5/15 on the geriatric depression scale,
- Score on the telephone version of the MMSE < 19,
- Psychiatric or neurological diagnosis,
- Presence of major functional limitations likely to affect the individual's ability to stand and walk independently.
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 |
|---|---|---|
| Experimental: Well-being intervention followed by classic intervention2 x 6 weeks of weekly museum visits | Other | Classic Museum intervention, Well-Being Museum intervention |
| Experimental: Classic intervention followed by well-being intervention2 x 6 weeks of weekly museum visits | Other | Classic Museum intervention, Well-Being Museum intervention |
Primary outcome
Change in the activity evoked within the ventrolateral prefrontal cortex during the contemplation of artwork
Time frame: Before and after the 6 weeks of interventions
Hemodynamic variations in the region of interest (concentration of oxygenated hemoglobin [HbO2], no units).
1 secondary outcome
Change in the activity evoked within the medial prefrontal cortex during the contemplation of artwork
Time frame: Before and after the 6 weeks of interventions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Well-being intervention followed by classic intervention and Experimental: Classic intervention followed by well-being intervention in people with Atrial Fibrillation Recurrent and Aging, run by Louis Bherer at 1 site in Canada.
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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emma G Dupuy, PhD (514-374-1480 ext. 4345, emma.dupuy@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the activity evoked within the ventrolateral prefrontal cortex during the contemplation of artwork (time frame: Before and after the 6 weeks of interventions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.