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Person-centred Use of Music in residents living with dementia and Associated changes in behaviour in care homes: the PUMA study

Person-centred Use of Music in dementia: Associated changed behaviours in care homes (PUMA): a cluster randomised controlled trial: The PUMA study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11328023
Enrollment
406
Registered
2026-03-02
Start date
2026-06-30
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The study focuses on dementia and associated changed behaviours in care home residents. Mental and Behavioural Disorders

Interventions

Participants will be residents with dementia and changed behaviours from 58 care homes, randomised at the cluster level in a 1:1 ratio to receive either usual care or a personalised music intervention
the intervention is tailored to each resident, incorporated into care plans, and applied flexibly over 12 months.

Sponsors

Sheffield Health Partnership University NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of dementia as recorded in care records 2. Resident identified by care staff as presenting with a behavioural care need (e.g. distress, anxiety, apathy, agitation) 3. Permanent residency in a care home with continuous care provision (24 hours a day, 365 days a year) 4. Capacity to consent, or availability of a designated consultee to provide an opinion on participation 5. Involvement of a permanent care staff member who consents to participate and is supported by their manager to undergo training and deliver the intervention

Exclusion criteria

Exclusion criteria: 1. Absence of a known diagnosis of dementia recorded in care records 2. Residents not identified by care staff as presenting with any behavioural care need (e.g. distress, anxiety, apathy, agitation) 3. Known sensitivity to music that is especially upsetting 4. Currently in respite or short-term care 5. Already receiving personalised music as part of their care plan 6. Care staff members on temporary contracts or expected to leave within the next 12 months

Design outcomes

Primary

MeasureTime frame
Neuropsychiatric symptoms measured using the Neuropsychiatric Inventory – Nursing Home version (NPI-NH), with the primary comparison at 6 months post-randomisation (assessed at baseline, 3, 6, and 12 months)

Secondary

MeasureTime frame
1. Resident wellbeing measured using the Music in Dementia Assessment Scale (MiDAS) at 3, 6, and 12 months (intervention arm only) 2. Quality of life measured using the Quality of Life in Late-stage Dementia scale (QUALID) at baseline, 3, 6, and 12 months 3. Health-related quality of life measured using the EQ Health and Wellbeing Proxy (EQ-HWB-Proxy) at baseline, 3, 6, and 12 months 4. Resource use measured using the bespoke Resource-Use Measure (RUM) at baseline, 3, 6, and 12 months 5. Carer experience measured using the Carer Experience Scale at baseline, 3, 6, and 12 months 6. Antipsychotic medication use measured using care record review at baseline, 3, 6, and 12 months

Countries

England, United Kingdom

Contacts

Public ContactDaniel Hind
d.hind@leeds.ac.uk+44 113 243 1751

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 30, 2026