- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06130358
Investigating the Effects of a Museum Intervention on the Psychological and Cardiac Health of Older Adults (HeART-BRAIN)
November 16, 2023 updated by: Louis Bherer
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.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Emma G Dupuy, PhD
- Phone Number: 4345 514-374-1480
- Email: emma.dupuy@umontreal.ca
Study Contact Backup
- Name: Louis G Bherer, PhD
- Phone Number: 2059 514-376-3330
- Email: louis.bherer@umontreal.ca
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H1T1N6
- Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Well-Being Museum intervention
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.
|
2 x 6 weeks of weekly museum visits
2 x 6 weeks of weekly museum visits
|
|
Active Comparator: Classic Museum intervention
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.
|
2 x 6 weeks of weekly museum visits
2 x 6 weeks of weekly museum visits
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Before and after the 6 weeks of interventions
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Hemodynamic variations in the region of interest (concentration of oxygenated hemoglobin [HbO2], no units).
|
Before and after the 6 weeks of interventions
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive Reserve
Time Frame: Baseline
|
Rami and colleagues' cognitive reserve questionnaire (Scale ranges from 0-26, with a higher score indicating a greater cognitive reserve).
|
Baseline
|
|
Self-reported masculinity and femininity trait
Time Frame: Baseline
|
Short Form Bem Sex-Role Inventory questionnaire (30 items questionnaire with 10 items assessing the femininity traits, 10 items assessing the masculinity traits, and 10 items neutral, not scored.
Two scores are calculated for femininity and masculinity, respectively, and range from 10-70, whit a higher score indicating a higher femininity or masculinity trait).
|
Baseline
|
|
Change in Heart rate
Time Frame: Before and after the 6 weeks of interventions
|
bpm
|
Before and after the 6 weeks of interventions
|
|
Change in arterial pressure
Time Frame: Before and after the 6 weeks of interventions
|
mmHg
|
Before and after the 6 weeks of interventions
|
|
Change in salivary cortisol concentration
Time Frame: Before and after the 6 weeks of interventions
|
microg/l
|
Before and after the 6 weeks of interventions
|
|
Change in emotionnal regulation
Time Frame: Before and after the 6 weeks of interventions
|
Difficulties in Emotion Regulation Scale DERS-F scale (Score ranges from 36-180, with a higher score indicating more emotion regulation problems)
|
Before and after the 6 weeks of interventions
|
|
Change in perceived stress
Time Frame: Before and after the 6 weeks of interventions
|
Perceived Stress Scale questionnaire (Score ranges from 0-4, with 0 no stress,1 mild stress, 3 moderate stress and 4 severe).
|
Before and after the 6 weeks of interventions
|
|
Change in Depressive symptomatology
Time Frame: Before and after the 6 weeks of interventions
|
Geriatric Depression Scale questionnaire (Score ranges from 0-30, with a higher score indicating larger depressive symptomatology).
|
Before and after the 6 weeks of interventions
|
|
Change in Quality-of-life
Time Frame: Before and after the 6 weeks of interventions
|
36-Item Short Form Health Survey (Scale ranges from 0-100, with a higher score indicating a better health status).
|
Before and after the 6 weeks of interventions
|
|
Change in Perceived social support
Time Frame: Before and after the 6 weeks of interventions
|
Lubben Social Network Scale questionnaire (Score ranges from 0-30, with a higher score indicating more social engagement).
|
Before and after the 6 weeks of interventions
|
|
Change in Repetitive negative thinking
Time Frame: Before and after the 6 weeks of interventions
|
Perseverative thinking questionnaire (Score ranges from 0-60, with a higher score indicating more repetitive negative thinking).
|
Before and after the 6 weeks of interventions
|
|
Change in perceived fatigue
Time Frame: Before and after the 6 weeks of interventions
|
Fatigue Severity Scale (Score ranges from 9-63, with a higher score more fatigue)
|
Before and after the 6 weeks of interventions
|
|
Change in global cognition
Time Frame: Before and after the 6 weeks of interventions
|
MoCA total score (Score ranges from 0-30, with a higher score indicating better performance)
|
Before and after the 6 weeks of interventions
|
|
Change in executive functioning
Time Frame: Before and after the 6 weeks of interventions
|
Computerized Stroop task, Reaction time (ms)
|
Before and after the 6 weeks of interventions
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2024
Primary Completion (Estimated)
February 1, 2025
Study Completion (Estimated)
February 1, 2025
Study Registration Dates
First Submitted
November 8, 2023
First Submitted That Met QC Criteria
November 8, 2023
First Posted (Actual)
November 14, 2023
Study Record Updates
Last Update Posted (Estimated)
November 17, 2023
Last Update Submitted That Met QC Criteria
November 16, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICM 2024-3325
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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