Clinical trial NCT06805578: Exploring and Evaluating the Impact of 'Refresh and Reconnect!'
Official title: Exploring and Evaluating the Impact of 'Refresh and Reconnect!': A Museum-based Heritage Programme for Older Persons With Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Ageing
Mild Dementia
Well-being
Keywords: Social Prescription
Heritage
Museum
Mild Cognitive Impairment
Mild Dementia
Person with cognitive impairment
Artist
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
Collaborators: name: National Heritage Board, Singapore
name: National Museum Singapore, Singapore
First posted: 2025-02-03
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an exploratory study that adopts a quasi-experimental (single-arm, before-after) and mixed-methods quantitative and qualitative design.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Dementia and mild cognitive impairment are a rising concern for the ageing population in Singapore, leading to diminished quality of life and health outcomes. Arts-based interventions in a museum setting have been shown to improve cognitive health and well-being for Persons with Cognitive Impairment (PWCIs), however little is known about the relationship of heritage-based interventions on the health and well-being of PWCIs.

This mixed-methods study evaluates the 6-week "Refresh and Reconnect!" programme (R\&R!), a museum-based heritage programme including guided artist-led activities and tours of the National Museum of Singapore.

(i) In the quantitative study (n = 64-120 PWCIs, comprising with mild cognitive impairment (MCI) or mild dementia), assessments will be conducted at 2 time points (pre-programme, post-programme) to evaluate change in cognitive, social, and mental well-being.

ii) In the qualitative study, ethnographic observations of the R\&R! programme; ethnographic interviews with staff (n= max 3), \& artists (n= max 6); and in-depth interviews with PWCIs (n=16) will be used to elicit the underlying context-mechanisms-outcomes which enable R\&R! success. Programme volunteers will also be engaged through casual or informal conversations as part of the ethnographic observations.

The study will provide valuable insights for the development of effective, non-pharmacological interventions for PWCIs. The primary objectives of the study are to (a) compare the change (before and after programme participation) in the health and well-being of PWCIs participating in the programme, and (b) assess the change (before and after programme participation) in the perception of the museum, 'heritage' and learning among PWCIs participating in the programme. The secondary aims are to understand the factors, contexts, and mechanisms that influence the implementation of the museum-based intervention and its effects, including the place-based effects of the curated museum Reunion space for PWCIs.

Achieving the objectives will help answer the following research questions:

1. To what extent, and how does participation in the "Refresh and Reconnect!" programme impact health and well-being of PWCIs?
2. To what extent, and how does participation in the programme affect the study participants' understanding and perception of the museum as a potential place to enhance one's health and well-being? \[Note: Study Participants include all who are participating in the study such as PWCIs and those who are implementing (e.g. museum staff), facilitating (e.g. artists) and assisting (e.g. volunteers) with the R\&R! Programme\]
3. What are the contexts and mechanisms that influence the implementation of the programme?

These findings are of significant public health importance for Singapore, potentially informing policy decisions, resource allocation, and healthcare strategies to better support PWCIs, ultimately improving their quality of life. Findings of the study may also contribute to similar heritage-based programmes in future, contributing to the understanding of key elements of programme success, and for whom these programmes are effective for.


Eligibility criteria: Inclusion Criteria:

* Fulfils the programme recruitment criteria and registers for the programme through National Museum of Singapore's collaborating partners; AND
* Provides consent for participation in the study personally; AND
* Willing and able to participate in interviews independently, without proxy; AND
* Scores between 22 to 27 on the MoCA (or 22 to 26 for participants with less than 10 years of education; or 22 to 25 for participants who are unable to provide information on the number of years of formal education completed). These thresholds follow the recommendation of MoCA use in determining mild cognitive impairment and mild dementia in Singapore and draw from studies concerning mental capacity and consent for persons living with cognitive impairment

Exclusion Criteria:

* Whose cognitive impairment status cannot be confirmed by the administered screener; OR
* Do not give consent to participate in the study; OR
* Scores below 22 on the MoCA, or above 27 (or 26 for participants with less than 10 years of education; or 25 for participants who are unable to provide information on the number of years of formal education completed)

Primary outcomes:
measure: Change from baseline in Quality of life at the end of the 6-week intervention
timeFrame: From enrolment to the end of intervention at 6 weeks
measure: Change from baseline in Health-related Quality of life at the end of the 6-week intervention
timeFrame: From enrolment to the end of intervention at 6 weeks
measure: Change from baseline in anxiety and depression at the end of the 6-week intervention
timeFrame: From enrolment to the end of intervention at 6 weeks
measure: Change from baseline in loneliness at the end of the 6-week intervention
timeFrame: From enrolment to the end of intervention at 6 weeks
measure: Change from baseline in social isolation at the end of the 6-week intervention
timeFrame: From enrolment to the end of intervention at 6 weeks
measure: Change from baseline in ageing perceptions at the end of the 6-week intervention
timeFrame: From enrolment to the end of intervention at 6 weeks
measure: Change from baseline in motivations to learn at the end of the 6-week intervention
timeFrame: From enrolment to the end of intervention at 6 weeks
measure: Change from baseline in Montreal Cognitive Assessment score at the end of the 6-week intervention
timeFrame: From enrolment to the end of intervention at 6 weeks
Secondary outcomes:
measure: Changes to subjective well-being after each session of the 6-week intervention
timeFrame: From enrolment to the end of intervention at 6 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Museum of Singapore
Study officials:
affiliation: Duke-NUS Graduate Medical School
name: Rahul Malhotra, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke-NUS Graduate Medical School
name: Ad Maulod, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
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