Music Therapy in Methodist Homes: a Study Investigating the Impact of a Music Therapy Programme

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Methodist Homes for the Aged
ClinicalTrials.gov Identifier:
NCT01744600
First received: November 30, 2012
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

The study is a cluster randomised control trial, which aims to investigate the effectiveness of music therapy in minimising Behavioural and Psychological Symptoms of Dementia (BPSD) in older adults with dementia. In particular, the study aims to identify the main components of music therapy that are key in achieving this. The study will also explore carers' perceptions of music therapy, and investigate whether carers become more attentive to patients' needs and more able to manage patients' BPSD as a result of the music therapy programme.


Condition Intervention
Dementia
Behavioral: Music Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Music Therapy in Methodist Homes: a Cluster Randomised Controlled Trial Including Mixed Methods Analysis Investigating the Efficacy of the Impact of a Music Therapy Programme on Caring for People With Dementia Who Have Behavioural Symptoms.

Resource links provided by NLM:


Further study details as provided by Methodist Homes for the Aged:

Primary Outcome Measures:
  • Neuropsychiatric Inventory [ Time Frame: At baseline in the 2 weeks prior to the music therapy intervention, then at weeks 11-12, weeks 21-22 and as a follow-up at week 27-28. ] [ Designated as safety issue: No ]

    The NPI assesses the neuropsychiatric symptoms and pathology of patients with Alzheimer's disease and other neurodegenerative disorders.

    Ten behavioural areas (delusions, hallucinations, agitation/aggressions, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability and aberrant motor behaviour) and two neuro-vegetative areas (sleep and night-time behaviour disorders, and appetite and eating disorders) are assessed.

    Changes in these areas of behaviour over the two weeks prior to interview will be investigated. This project will employ the version of the NPI which has been developed for use within institutional settings (NPI-NH). The interviews will be conducted with an informed professional caregiver.



Secondary Outcome Measures:
  • Dementia Care Mapping [ Time Frame: At baseline in the 2 weeks prior to the start of the music therapy intervention, then at weeks 11-12, weeks 21-22 and as a follow-up at weeks 27-28. ] [ Designated as safety issue: No ]

    Dementia Care Mapping (DCM) is an observational tool used within institutional settings that aims to provide information on residents' well-being and the quality of care delivered by staff. During a mapping session, the mapper(s) record resident's behaviours, mood, engagement and interactions with staff over a defined time period, within a communal area. For the purposes of this study, participants will be observed for two consecutive hours beginning from one hour prior to lunch.

    Each construct of behaviour, mood and engagement is systematically coded within 5-minute time frames, and the resulting data set is then analysed to give an overall 'wellbeing' level. Staff-resident interactions are recorded as and when they occur, according to type and potential for well-being, and are named as 'personal detractors' or 'personal enhancers'. These aim to give an overall picture of the level and quality of person-centred-care being delivered.


  • Grounded theory-based interviews [ Time Frame: The two sets of interviews will be carried out during weeks 23 and 25. ] [ Designated as safety issue: No ]
    Two sets of Grounded Theory-based interviews will be carried out with care staff to explore their perceptions of music therapy. Grounded theory, developed by Glaser and Strauss (1967), is an inductive methodology by which theories are systematically generated from data without the use of pre-determined hypotheses. The process consists of a period of data collection; 'coding', in which themes and categories within the data are identified; 'memo-ing', the writing up of theoretical ideas on the codes and their relationships; and 'sorting' the memo's into an outline of the emerging theory. The phases of data collection, coding and memo-ing are ongoing and overlap, enabling an organic, flexible approach for themes to emerge within.

  • Microanalysis of video recordings of sessions [ Time Frame: Video recordings of music therapy sessions will be analysed for the duration of the 22 week intervention period, immediately after each weekly music therapy session. ] [ Designated as safety issue: No ]

    The method of microanalysis employed in this project will follow a similar procedure to those outlined by Ridder (2003), De Backer, (2005) and Trondalen (2005).

    After each music therapy session, the research assistant and music therapist will play back the video recording and transcribe the interactions and expressions of the therapist and client. An Excel file developed by the Lead Researcher for this purpose will be used during this process.

    The session will be divided into one-second timeframes and data will be recorded separately for both the therapist and client. For each timeframe that an expression is observed, a code will be chosen and inputted according to the nature of the client or therapist's expressions: musical, verbal, non-verbal or mixed. 'Special events' will also be recorded as and when they happen; these are sudden behaviours or changes in behaviours that raise questions and reflect something significant about the experience of the client in that moment.



Estimated Enrollment: 31
Study Start Date: February 2013
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Music Therapy
Participants in the experimental group will receive one active individual music therapy session each week for 22 weeks. Each session will last thirty minutes.
Behavioral: Music Therapy
The music therapy intervention will consist of individual active music therapy session each week for a period of 22 weeks. Each session will last 30 minutes.
No Intervention: Control
Participants in the control group will receive normal, standard daily care for the 22 week period.

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  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

31 participants are proposed to be recruited in total. This number comprises 16 resident participants, 14 staff participants and 1 music therapist.

The music therapist has already been recruited for the study and works within for the organisation's music therapy service in the two homes to be used as the research sites. The inclusion and exclusion criteria for staff and residents are outlined below.

Inclusion Criteria:

The proposed inclusion criteria for care home residents are as follows:

  • Participants will be a resident at one of the two residential homes identified as the research sites, in one of the two house units that will be used in the project in each home.
  • Participants will have a diagnosis of dementia
  • Participants will display at least one symptom of BPSD
  • Participants will be at least 40 years of age

The proposed inclusion criteria for staff participants are as follows:

  • Staff participants will have at least three months' experience of working with the resident participant(s)
  • Staff participants will have an in-depth knowledge of the resident participant(s) in a 'keyworker' role

Exclusion Criteria:

The proposed exclusion criterion for care home residents is as follows:

• Residents will be excluded if their health appears to be at a risk which raises concerns regarding their sustained involvement within the study, apparent from a general health examination with their General Practitioner

The proposed exclusion criteria for care staff participants is as follows:

  • Staff who have not worked with the resident participant(s) in a 'keyworker' role for at least three months.
  • Staff who would be unable to regularly work on the specific days they would be required within the home.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744600

Locations
United Kingdom
The Homestead
Carterton, Oxfordshire, United Kingdom, OX18 1NA
Fitzwarren House
Swindon, United Kingdom, SN3 4TD
Sponsors and Collaborators
Methodist Homes for the Aged
Investigators
Principal Investigator: Ming Hung Hsu, MA Methodist Homes
  More Information

Publications:
Responsible Party: Methodist Homes for the Aged
ClinicalTrials.gov Identifier: NCT01744600     History of Changes
Other Study ID Numbers: MTRP-301013
Study First Received: November 30, 2012
Last Updated: May 15, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Methodist Homes for the Aged:
Dementia
Music Therapy

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014