- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06805578
Exploring and Evaluating the Impact of 'Refresh and Reconnect!' (ReCognition)
Exploring and Evaluating the Impact of 'Refresh and Reconnect!': A Museum-based Heritage Programme for Older Persons With Cognitive Impairment
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:
- To what extent, and how does participation in the "Refresh and Reconnect!" programme impact health and well-being of PWCIs?
- 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]
- 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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rahul Malhotra, MD, MPH
- Phone Number: +6593891930
- Email: rahul.malhotra@duke-nus.edu.sg
Study Contact Backup
- Name: Ad Maulod, PhD, MSc
- Phone Number: +6596445487
- Email: ad.maulod@duke-nus.edu.sg
Study Locations
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Singapore, Singapore, 178897
- National Museum of Singapore
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Contact:
- Senior Manager (Programmes)
- Phone Number: +6569821262
- Email: clara_ang@nhb.gov.sg
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Sub-Investigator:
- Senior Manager (Curatorial & Programmes)
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Sub-Investigator:
- Senior Manager (Programmes)
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Sub-Investigator:
- Assistant Manager (Curatorial and Programmes)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention Group
Persons with cognitive impairment will undergo a 6-week heritage-based intervention programme conducted by the National Museum of Singapore, which includes guided gallery tours led by the museum's Care Facilitator volunteers and artist-led hands-on activities based on various art forms.
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The 6-week 'Refresh and Reconnect!' programme includes guided gallery tours led by the museum's Care Facilitator volunteers and artist-led hands-on activities based on various art forms (e.g.
artist-led dance, art, or drama workshops).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from baseline in Quality of life at the end of the 6-week intervention
Time Frame: From enrolment to the end of intervention at 6 weeks
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Quality of life (QoL) will be assessed using the Control, Autonomy, Self-Realization, and Pleasure-11-SG (CASP-11-SG) scale.
CASP-11-SG has been validated in Singapore.
It has 11 items covering two domains: Control-Autonomy, and Self-realization-Pleasure (Table 1).
Items are scored on a four-point response scale [Often (score = 3), Sometimes, Not Often, Never (score = 0)] based on how often the participant feels the way described in the item.
Negatively worded items are reverse-coded.
A higher total score (range: 0-33) indicates higher QoL.
Control-Autonomy subscale (range: 0-18) and Self-realization-Pleasure subscale (range: 0-15) scores are also calculated.
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From enrolment to the end of intervention at 6 weeks
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Change from baseline in Health-related Quality of life at the end of the 6-week intervention
Time Frame: From enrolment to the end of intervention at 6 weeks
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Health-related Quality of life (HRQoL) will be assessed using the EuroQol- 5 Dimension (EQ-5D) questionnaire.
The EQ-5D comprises five questions on mobility, self-care, pain, usual activities, and psychological status with five possible answers for each item (1=no problem, 2=slight problem, 3=moderate problem, 4=severe problem, 5=unable to do).
Overall, a total score of 5 indicates the best health state, whereas higher scores indicate more severe or frequent problems.
In addition, there is a visual analogue of the scale to indicate general health status, with a score of 100 indicating the best health status.
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From enrolment to the end of intervention at 6 weeks
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Change from baseline in anxiety and depression at the end of the 6-week intervention
Time Frame: From enrolment to the end of intervention at 6 weeks
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Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS).
It is a self-reported rating scale of 14 items on a 4-point Likert scale (range 0-3), with 7 items each for anxiety and depression.
The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).
Scores of 11 or more on either subscale are a significant 'case' of psychological morbidity, while scores of 8-10 represents 'borderline' and 0-7 'normal'.
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From enrolment to the end of intervention at 6 weeks
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Change from baseline in loneliness at the end of the 6-week intervention
Time Frame: From enrolment to the end of intervention at 6 weeks
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Loneliness will be assessed using The Three-Item Loneliness Scale.
Each item of the scale has a five-point Likert response option: "Always" (scored as 4) "Fairly Often" (3), "Occasionally" (2), "Rarely" (1), and "Never" (scored as 0).
The scores for each individual question can be added together to give a possible range of scores from 0 to 12. Higher scores indicate greater degrees of loneliness.
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From enrolment to the end of intervention at 6 weeks
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Change from baseline in social isolation at the end of the 6-week intervention
Time Frame: From enrolment to the end of intervention at 6 weeks
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Lubbens Social Network Scale 6-item (LSNS-6) is a social engagement scale that consists of six items.
The score for each item ranges from 0 to 5, with 0 indicating none and 5 indicating nine or more.
The total score is calculated by finding the sum of all items, and ranges from 0 to 30.
A higher score indicates more social engagement.
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From enrolment to the end of intervention at 6 weeks
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Change from baseline in ageing perceptions at the end of the 6-week intervention
Time Frame: From enrolment to the end of intervention at 6 weeks
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The Brief Ageing Perceptions Questionnaire (Brief-APQ) measure comprise Likert scale items that represent seven ageing perception domains.
Participants rate their agreement with a series of statements - for example "I am always aware of my age" or "As I get older I can take part in fewer activities" with a five-point response scale with the options: Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree.
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From enrolment to the end of intervention at 6 weeks
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Change from baseline in motivations to learn at the end of the 6-week intervention
Time Frame: From enrolment to the end of intervention at 6 weeks
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Motivations to learn will be assessed using the Readiness-to-learn Scale from the background questionnaire of the Programme for the International Assessment of Adult Competencies (PIAAC).
This scale assesses participants' motivations to learn, and the learning strategies they adopt to solve challenges in learning.
The response categories for this item range from not at all (1), to a very high extent (5).
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From enrolment to the end of intervention at 6 weeks
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Change from baseline in Montreal Cognitive Assessment score at the end of the 6-week intervention
Time Frame: From enrolment to the end of intervention at 6 weeks
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Cognitive performance will be assessed using the Montreal Cognitive assessment (MoCA).
MoCA assessment parameters are visuospatial/ executive, naming ability, vigilance, verbal fluency, delayed recall, and abstractions.
The maximum MoCA score is 30 points.
MCI (Mild Cognitive Impairment) is indicated by a score of less than 27 for those with 10 or more years of education or a score of less than 26 for those with less than 10 years of education (following the recommendation of MoCA use in Singapore).
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From enrolment to the end of intervention at 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes to subjective well-being after each session of the 6-week intervention
Time Frame: From enrolment to the end of intervention at 6 weeks
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Museum-based subjective well-being will be assessed by University College London (UCL) Museum Wellbeing Measures toolkit.
The toolkit includes a 12-item Generic Wellbeing Questionnaire (GWQ) and Positive Wellbeing Measures Umbrella, designed specifically for museum projects.
The GWQ uses statements that refer to an emotion or life quality that participants might have experienced during the museum activity, such as 'I felt confident'.
These are rated from 1 ('None of the time') to 5 ('All of the time').
The Positive Wellbeing Umbrella consist of a hexagonal shape with six sections of different colours.
Each of the six sections has a word next to it related to a wellbeing mood or emotion and responses are ranged from one (I don't feel) to five (I feel extremely).
Participants are required to rate the extent they feel the wellbeing word at that moment in time by circling the appropriate number.
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From enrolment to the end of intervention at 6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rahul Malhotra, MD, MPH, Duke-NUS Graduate Medical School
- Principal Investigator: Ad Maulod, PhD, MSc, Duke-NUS Graduate Medical School
Publications and helpful links
General Publications
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Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUS-IRB-2024-259
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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