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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Experimental: Well-being intervention followed by classic intervention
2 x 6 weeks of weekly museum visits
Other: Experimental: Classic intervention followed by well-being intervention
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.
Other: Experimental: Well-being intervention followed by classic intervention
2 x 6 weeks of weekly museum visits
Other: Experimental: Classic intervention followed by well-being intervention
2 x 6 weeks of weekly museum visits

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Louis Bherer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mitacs
Université de Montréal
Fonds de la Recherche en Santé du Québec

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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