NCT05176444

Brief Summary

The purpose of this study is to implement and evaluate a music therapy intervention in care homes. The primary aim is to assess whether implementing the intervention will have an impact on unmet in care homes for people living with dementia. Researchers will also examine the feasibility of a music therapy programme in care homes and its effects on care staff and residents with cognitive impairment. Care home staff will also receive training with music therapists via video communications to help staff use music therapy techniques to support people living with dementia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

July 4, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

1.9 years

First QC Date

December 15, 2021

Last Update Submit

January 22, 2024

Conditions

Keywords

DementiaMusic therapyCognitionCare homeQuality of careNon-pharmacological interventionNeedsNeuropsychiatric symptoms

Outcome Measures

Primary Outcomes (1)

  • Camberwell Assessment of Needs in the Elderly - CANE

    For people with cognitive impairment - to measure the quality of care in care homes by assessing individual needs. This measure examines met and unmet needs in older people in 24 areas from self-care to communicative abilities. 1 = a met need, 2 = an unmet need. Met needs and unmet needs are totalled. A higher score indicates a higher number of needs.

    15 minutes

Secondary Outcomes (10)

  • Standardised Mini Mental State Examination - SMMSE

    15 minutes

  • Neuropsychiatric Inventory Nursing Homes - NPI-NH

    12 minutes

  • EuroQoL - EQ-5D-5L - self completion

    5 minutes

  • EuroQoL - EQ-5D-5L - proxy

    5 minutes

  • Barthel Index (BI)

    10 minutes

  • +5 more secondary outcomes

Study Arms (2)

Music therapy intervention

EXPERIMENTAL

Music therapy

Behavioral: Music therapy

Control group - standard care

NO INTERVENTION

Standard care for residents with cognitive impairment. Staff will not receive music therapy training.

Interventions

Music therapyBEHAVIORAL

Individual music therapy sessions across 12-weeks with people with cognitive impairment/dementia. Music therapy training for care home staff at four time points across 12-weeks.

Music therapy intervention

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be aged 50+ years
  • Participants will be a resident of one of the 12 care homes taking part
  • For each participant, there must be clinical evidence of cognitive impairment. This will be determined by a score of 24 or under on the SMMSE
  • Each participant must display at least one behavioural/psychological symptom of dementia. This will be determined by a score of 4 or higher on the NPI-NH.
  • Participants must be aged 18+ years
  • Participants must have worked in the care home for at least 3 months
  • Participants will be required to have in-depth knowledge of the resident participant(s). This will be determined through communications with home managers to ensure each staff member is paired with a resident they provide regular care for.

You may not qualify if:

  • \- Participants who's health appears to be at risk which raises the concerns of their sustained involvement with the study. This would be evident from a health assessment from a general practitioner. Given that this is a music therapy study, this could also include people with a hearing impairment.
  • \- Staff who cannot adequately answer on behalf of the residents due to lack of knowledge of the residents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Ridgemount

Banstead, Surrey, SM7 2BQ, United Kingdom

Location

Oakleigh, Godstone

London, Surrey, RH9 8BD, United Kingdom

Location

Greenacres, Banstead

London, Surrey, SM7 2BQ, United Kingdom

Location

Hatfield House

Doncaster, DN7 6JQ, United Kingdom

Location

Simon Marks Court

Leeds, LS21 1RJ, United Kingdom

Location

Oak Tree Lodge

Leeds, LS9 6BT, United Kingdom

Location

Kimberly Court

Newquay, TR7 1JG, United Kingdom

Location

Wharfside

Otley, LS21 1RJ, United Kingdom

Location

St Anne's

Saltash, PL12 6DJ, United Kingdom

Location

Prior Bank

Sheffield, S11 9AB, United Kingdom

Location

Herries Lodge

Sheffield, S5 8TT, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Cognitive DysfunctionDementia

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Helen Odell-Miller, PhD

    Anglia Ruskin University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2021

First Posted

January 4, 2022

Study Start

July 4, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Data will be anonymous

Locations