Clinical trial NCT07011498: Dementia Choirs for Social and Psychological Wellbeing
Official title: Connecting Through Choir Singing: Dementia Choirs to Reduce Loneliness in Home-dwelling Persons Living With Dementia and Their Caregivers - a Crossover Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Informal Caregivers (Family and Friends)
Keywords: Dementia
Choir
Loneliness
Music therapy
Lead sponsor: Norwegian Academy of Music
Sponsor class: OTHER
Collaborators: name: Oslo Municipality
name: Institute of Clinical Medicine, University of Oslo
name: University of Oslo
First posted: 2025-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study has a single group model in a crossover design. In the study, participants will be recruited to participate in dementia choirs. The choirs will be divided into two groups. Participants in each group will complete all assessments at the same timepoints but receive choir activity at different times.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Loneliness is common in both persons living with dementia and their informal caregivers, and a factor negatively affecting disease progression, health and wellbeing. However, intervention studies to address loneliness show inconsistent effects. This study aims to evaluate effect of a community-based group intervention - music therapy informed dementia choirs - on loneliness for home-dwelling people with dementia and their informal caregivers. We will recruit participants to five dementia choirs with 15-20 people in each and implement a crossover study with measures collected at four timepoints: baseline, 12-week follow up, 22-week follow-up after an extended summer holiday, and 12-week follow-up after the summer holiday. The primary outcome, loneliness in participants living with dementia, will be measured using the De Jong Gierveld loneliness scale. Secondary outcomes will be depression, experience of meaning in life, apathy and mood for the participants living with dementia, and loneliness and caregiver burden for the informal caregivers. Cognition in the participants living with dementia, measured with the RUDAS assessment tool, will be included as a control variable. Further, measurements to evaluate the cost effectiveness of the choir intervention will be included, and qualitative data collected through semi-structured interviews to explore the experiences and possible impacts of the choir intervention in the participants' lives.


Eligibility criteria: Inclusion Criteria:

* Dementia diagnosis (Alzheimers, Lewy-body, fronto-temporal, vascular, mixed, Parkinson's dementia) or cognitive impairment as reported by the person themselves/their caregiver
* Informal caregiver of participant with dementia: A person who has a close relationship with a recruited choir participant living with dementia. A close relationship may for instance be a spouse/partner, sibling, adult child, friend, niece or nephew
* Living at home in the community

Exclusion Criteria:

* Significant hearing impairment that is not resolved through the use of a hearing aid device and limit their capacity to enjoy musical experiences.
* Formal (paid) caregiver of participant with dementia

Primary outcomes:
measure: Change from baseline in degree of loneliness in participants with dementia at 12 weeks (primary), 22 weeks and 36 weeks follow up
timeFrame: From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.
Secondary outcomes:
measure: Change from baseline in degree of depression in participants with dementia to 12-week (primary timepoint), 22-week and 26-week follow up
timeFrame: From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.
measure: Change from baseline in degree of self-reported meaning in life in participants with dementia to 12-week (primary timepoint), 22-week and 26-week follow up
timeFrame: From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.
measure: Change from baseline in degree of apathy in participants with dementia to 12-week (primary timepoint), 22-week and 26-week follow up
timeFrame: From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.
measure: Change from baseline in degree of loneliness in informal caregivers of participants with dementia to 12-week (primary timepoint), 22-week and 26-week follow up
timeFrame: From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.
measure: Change from baseline in degree of caregiver burden to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.
timeFrame: From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.
measure: Change of mood in participant with dementia from before to after choir rehearsals
timeFrame: From before to after rehearsals for rehearsals 2, 6 and 11 (per choir).
Other outcomes:
measure: Change from baseline in cognition of participants with dementia to 12-week and 36-week follow up
timeFrame: Entire intervention period comprising three measurements (baseline, 12-week follow-up, and final 12-week follow-up after an extended summer holiday)
measure: Caregiver experience of choirs as a relief or a burden
timeFrame: At 36-week follow-up and during prolonged intervention after quantitative assessments
measure: Change from baseline in Quality of life in participants with dementia, Quality-adjusted life-years to 12-week follow up
timeFrame: From baseline to 12-week follow up
measure: Resource use in dementia care
timeFrame: From baseline to end of the first 12 week intervention period.
measure: Rehearsing at home
timeFrame: Entire intervention from second measurement (12-week follow-up, 22-week follow-up after an extended summer holiday (lasting 8 weeks), and 12-week follow-up after the summer holiday)
measure: Participants experiences of choir singing
timeFrame: Qualitative interviews will be conducted between 36-week follow-up and study completion.
measure: Adherence to intervention
timeFrame: Entire intervention period comprising four measurements (baseline, 12-week follow-up, 22-week follow-up after an extended summer holiday (lasting 8 weeks), and 12-week follow-up after the summer holiday)
measure: Adverse events
timeFrame: From baseline through study completion, app. 1 year
measure: Change from baseline in Quality of life in informal caregivers of participants with dementia, Quality-adjusted life-years to 12-week follow up
timeFrame: From baseline to 12-week follow up
Locations:
city: Oslo
country: Norway
facility: Norwegian Academy of Music, Oslo
Study officials:
affiliation: Norwegian Academy of Music
name: Kjersti Johansson, PhD
role: PRINCIPAL_INVESTIGATOR
References: