The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Singapore Art-Health Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05945589
Recruitment Status : Completed
First Posted : July 14, 2023
Last Update Posted : July 14, 2023
Sponsor:
Collaborators:
National Gallery Singapore, Singapore
Sheffield Hallam University
Université de Montréal
Information provided by (Responsible Party):
Andy Hau Yan Ho, PhD, EdD, Nanyang Technological University

Brief Summary:

The goal of the Singapore Art-Health RCT is to examine the effect of a standardized 12-week museum -based participatory art program on health condition, well-being, and quality of life in older community dweller, one that adheres to the Montreal Art-Health framework with culturally specific modifications that are fitting to the local Singaporean context.

Participants will be randomized into an intervention group of a passive control group. Participants in the intervention group will be invited to participate in the 12-week Singapore Art-Health Intervention held at the National Gallery Singapore. All participants will be invited to complete four online psychometric assessments. Participants in the intervention group will be invited to completed an additional post-intervention survey and a feasibility focus group.


Condition or disease Intervention/treatment Phase
Art Wellness, Psychological Frailty Quality of Life Behavioral: Singapore A-Health Intervention Not Applicable

Detailed Description:

Background: Population aging continues to be global health challenge. The prevalence of longstanding age-related conditions such as worsening physical, social, and mental health is expected to increase exponentially with a rapidly ageing population. The practice of participatory art in various settings has been found to be effective in the promotion, prevention and management of health and wellbeing conditions across the life span. However, its effect on health condition among the older population, particularly in the Asian context remains to be investigated. In Montreal, findings from a pilot study provided strong evidence to show that a 12-week, standardized "Art-Health" participatory art program had multidimensional positive effects on the health outcomes of older community dwelling participants including improvements in wellbeing, quality of life, and frail condition.

Current Proposal: The current research will adopt and modify the Montreal Art-Health participatory art framework with local cultural specificity (i.e. The Singapore Art-Health Intervention), and tests its effectiveness in healthy and wellness promotion among a sample of Singaporean older adults via a randomized control trial.

Research Design: The study adopts a participatory action research paradigm and a single-site, open-label Randomized Control Trial (RCT) design to develop and examine the effect of a standardized 12-week museum-based participatory art activity on health condition, wellbeing, and quality of life in older community dwellers.

Sampling and Randomization: Allowing for an attrition rate of 5% at follow-up, a target sample of 110 provides 90% power to detect an effect size of 0.55 (based on the results of the pilot study) between the intervention group and the control group at 5% level of significance (two-tailed test). Participants will be randomized into an intervention group of a passive control group. Participants in the intervention group will be invited to participate in the 12-week Singapore A-Health Intervention held at the National Gallery Singapore.

Intervention Design: The Singapore Art-Health Intervention will span 12 weeks, with each weekly session lasting for two hours. The program is designed to impart basic art appreciation skill (formal analysis in art) and art making techniques to participants through engagement with the collection at the museum.

Outcome measures and Data Analysis: All participants will be invited to complete four online psychometric assessments. Participants in the intervention group will be invited to completed an additional post-intervention survey and a feasibility focus group. For the quantitative data, between and within comparisons of outcomes will be conducted by mixed model analysis of variance (ANOVA), repeated measures ANOVA, and pairwise t-tests with Bonferroni correction. The focus group discussions will be analyzed using thematic analysis with a grounded theory approach to provide insights to the participant's experience and impact of the Singapore Art-Health Intervention.

Importance of Research: The current research will develop and test the effectiveness of a culturally-specific Art-Health participatory art program on health and wellness promotion among a sample of Singaporean older adults. Working collaboratively with the National Gallery Singapore in program development and implementation will serve to ensure program sustainability upon research completion. This collaboration will also foster practice and knowledge transfer to accelerate creative ageing in the local society. Moreover, the findings will contribute to an international RCT for evaluating a standardized participatory art framework to address the impact of population ageing. It will be a potential breakthrough in the development of an efficient art and museum program for older adults locally and internationally.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention group participants will be invited to engaged in a 12-week participatory art program at the gallery. Participants in the control condition will not offered any art-based activities. All participants were advised not to participate in concurrent health art-based interventions during the research period.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Simple randomization was administered by a dedicated research team member using an automated randomizer. Consenting participants were randomly assigned a number, where 1 = Intervention group, and 2 = Control group. Participants and other members of the research team were blinded to the randomization outcomes, and the outcome of the allocation was revealed after completion of the baseline assessment.
Primary Purpose: Prevention
Official Title: Effects of Participatory Art-Based Activity On Health of Older Community-Dwellers: The Singapore Art-Health Randomized Control Trial Study
Actual Study Start Date : March 2, 2021
Actual Primary Completion Date : November 30, 2021
Actual Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: Singapore A-Health Group
A 12-week professionally led participatory art program at the gallery with each week comprising one 2-hour art session, totaling 24 hours of museum tours and participatory art activities.
Behavioral: Singapore A-Health Intervention
The Singapore A-Health Intervention spanned 12 weeks, with each weekly session lasting for two hours. The program is structured around three thematic domains of the past, present, and future. In each thematic domain consisting of four weeks, participants were tasked with creating an artwork related to the theme and incorporating the learned art techniques. The structure of each thematic domain follows the same structure: the first week involved a 45-minute docent-led gallery tour on three selected pieces of artworks, followed by a 75-minute artist-led brainstorming session where participants were introduced to the techniques and discuss ideas on the artwork to be created. The subsequent three sessions involved further guidance from the artist and a scaffolded delivery of art techniques for participants to incorporate their learning to their artwork. At the end of each domain, there was a showcase where participants present their artwork.

No Intervention: Control Group
No art-based activities offered and advised not to participate in concurrent health and art-based interventions during the 12-week research period.



Primary Outcome Measures :
  1. Quality of Life (EQ5D) [ Time Frame: Baseline ]
    Quality of life will be assessed by EuroQol-5D (EQ5D) which comprised of two parts: (1) 5-item scale on mobility, self-care, daily activities, pain, and depressive symptoms, (2) a visual analog scale of the participant's perceived health ranging from 0 (worst health) to 100 (best health one can imagine)

  2. Change in Quality of Life (EQ5D) [ Time Frame: 5-week follow-up ]
    Quality of life will be assessed by EuroQol-5D (EQ5D) which comprised of two parts: (1) 5-item scale on mobility, self-care, daily activities, pain, and depressive symptoms, (2) a visual analog scale of the participant's perceived health ranging from 0 (worst health) to 100 (best health one can imagine)

  3. Change in Quality of Life (EQ5D) [ Time Frame: 9-week follow-up ]
    Quality of life will be assessed by EuroQol-5D (EQ5D) which comprised of two parts: (1) 5-item scale on mobility, self-care, daily activities, pain, and depressive symptoms, (2) a visual analog scale of the participant's perceived health ranging from 0 (worst health) to 100 (best health one can imagine)

  4. Change in Quality of Life (EQ5D) [ Time Frame: 12-week follow-up ]
    Quality of life will be assessed by EuroQol-5D (EQ5D) which comprised of two parts: (1) 5-item scale on mobility, self-care, daily activities, pain, and depressive symptoms, (2) a visual analog scale of the participant's perceived health ranging from 0 (worst health) to 100 (best health one can imagine)

  5. Mental Wellbeing (WEMWBS) [ Time Frame: Baseline ]
    Mental Wellbeing will be assessed by Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS), a 14-item scale assessing various domains of wellbeing.

  6. Change in Mental Wellbeing (WEMWBS) [ Time Frame: 5-week follow-up ]
    Mental Wellbeing will be assessed by Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS), a 14-item scale assessing various domains of wellbeing.

  7. Change in Mental Wellbeing (WEMWBS) [ Time Frame: 9-week follow-up ]
    Mental Wellbeing will be assessed by Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS), a 14-item scale assessing various domains of wellbeing.

  8. Change in Mental Wellbeing (WEMWBS) [ Time Frame: 12-week follow-up ]
    Mental Wellbeing will be assessed by Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS), a 14-item scale assessing various domains of wellbeing.

  9. Frailty (CESAM) [ Time Frame: Baseline ]
    Frailty will be assessed by the Centre of Excellence on Longevity Self-administered Questionnaire (CESAM). It is a 20-item scale assessing multiple aspects of health such as drug intake, memory complaints, health service utilization, and activities of daily living.

  10. Change in Frailty (CESAM) [ Time Frame: 5-week follow-up ]
    Frailty will be assessed by the Centre of Excellence on Longevity Self-administered Questionnaire (CESAM). It is a 20-item scale assessing multiple aspects of health such as drug intake, memory complaints, health service utilization, and activities of daily living.

  11. Change in Frailty (CESAM) [ Time Frame: 9-week follow-up ]
    Frailty will be assessed by the Centre of Excellence on Longevity Self-administered Questionnaire (CESAM). It is a 20-item scale assessing multiple aspects of health such as drug intake, memory complaints, health service utilization, and activities of daily living.

  12. Change in Frailty (CESAM) [ Time Frame: 12-week follow-up ]
    Frailty will be assessed by the Centre of Excellence on Longevity Self-administered Questionnaire (CESAM). It is a 20-item scale assessing multiple aspects of health such as drug intake, memory complaints, health service utilization, and activities of daily living.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • individuals above the age of 60,
  • fluent in English
  • able to access the internet to complete the online psychometric assessments

Exclusion Criteria:

  • unable to provide informed consent
  • diagnosed with mental health conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05945589


Locations
Layout table for location information
Singapore
Nanyang Technological University
Singapore, Singapore, 637332
Sponsors and Collaborators
Nanyang Technological University
National Gallery Singapore, Singapore
Sheffield Hallam University
Université de Montréal
Investigators
Layout table for investigator information
Principal Investigator: Andy HY Ho, PhD, EdD Nanyang Technological University
Publications:
Layout table for additonal information
Responsible Party: Andy Hau Yan Ho, PhD, EdD, Principal Investigator, Nanyang Technological University
ClinicalTrials.gov Identifier: NCT05945589    
Other Study ID Numbers: IRB-2020-02-005
First Posted: July 14, 2023    Key Record Dates
Last Update Posted: July 14, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are currently no plans o make individual participant data (IPD) available to other researchers.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andy Hau Yan Ho, PhD, EdD, Nanyang Technological University:
Art
Museum
Quality of Life
Frailty
Additional relevant MeSH terms:
Layout table for MeSH terms
Frailty
Pathologic Processes