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DementiaNCT04236557

Individualized Music Playlist Based on ISO-Principle for De-escalating Agitation of People Living With Dementia

A study testing Music listening and Audio Book Listening in people with Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Abstract: Agitation is exhibited by almost every dementia patient during the course of illness, and that leads to detrimental consequences on both patients and caregivers. Listening to preferred music is found useful in reducing the agitation frequency of people with dementia. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Dementia
What is being tested?
Music listening and Audio Book Listening
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteHong Kong
Study dates
1 Nov 2022to 30 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Nursing home residents with medical diagnosed of any type of dementia; presented with significant agitation in the past two weeks before recruitment;
  • expected to be present in the facility every Monday to Friday during the study period; and
  • Aged 60 or above;

Who cannot join

  • Nursing home residents who were admitted to the nursing home for less than 3 months;
  • participating in other studies or experimental therapies, or blinded treatments;
  • those with comorbid psychiatric illness such as depression, schizophrenia;
  • or those with uncorrectable hearing impairment.
  • Notes:
  • Concurrent psychotropic medications over the study period is allowed but any change in the prescriptions will be monitore

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • School of Nursing, The Hong Kong Polytechnic University

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Individualized Music Playlist Based on ISO-Principle for De-escalating Agitation of People Living With Dementia: A Randomized Controlled Feasibility Study

Abstract:

Agitation is exhibited by almost every dementia patient during the course of illness, and that leads to detrimental consequences on both patients and caregivers. Listening to preferred music is found useful in reducing the agitation frequency of people with dementia. However, the music intervention is usually provided regularly and the music psychotherapy ISO-Principle is ignored in published studies. The ISO-Principle that commonly adopted in music therapy using live-music, suggests that characteristics of music being played (e.g. tempo, melody and lyrics) should match with the current state (e.g. manic/depressive) of the client, and gradually modify these characteristics to the desired state. This randomized feasibility trial aims to evaluate the feasibility of using individualized music playlist with the music genres sequenced according to the ISO-Principle, for de-escalating agitation of people with dementia, and provide preliminary evidence on efficacy.

Read more

Eighty-four nursing home residents with agitation will be randomly allocated into music listening or control groups. Acceptability, implementation and practicality, as well as efficacy (in terms of agitation intensity, stress and mood states before and after the de-escalating music intervention or control condition; and occurrence of agitation and other behavioural and psychological symptoms of dementia before and after the 6-week observation period).

Feasibility indicators will be reported descriptively. The efficacy of (1) music listening in de-escalating symptoms and (2) reducing occurrence frequency of symptoms after 6 weeks, will be analysed with Generalized Estimating Equation. If the findings are positive, the intervention have a great potential to be adopted as the gold standard of care in the nursing homes to solve a common yet detrimental clinical problem.

Read the detailed description
  1. Aims and objectives: This study is to evaluate the feasibility of the individualized music playlist based on ISO-Principle for de-escalating agitation of nursing home residents living with dementia. Objectives are as below:
  2. To evaluate the feasibility of the intervention in terms of recruitment, retention, and acceptability.
  3. To examine the preliminary effects of the intervention on participants' agitation, stress and emotion as compared to control group.
  4. To evaluate suitability of outcome assessment instruments.
  5. Methods:
  6. Design:
  • A two arms randomized controlled feasibility trial.
  1. Participants and setting:
  • The study participants will be recruited from participating residential care homes for the elderly in Hong Kong.
  1. Intervention group
  • Will receive usual care and a 30-minute personalized playlist with the preferred music sequenced according to ISO-Principle will be provided when the participant become agitated during the 6-week project period.
  1. Control group
  • Will receive usual care and a 30-minute audio recording of book reading wen the participant become agitated during the 6-week project period. They will receive a personalized playlist with the preferred music sequenced according to ISO-Principle when all the data collection is done.
  1. Outcomes:
  • recruitment rate, attrition rate, acceptability (field observation, comments from staffs), practicality (adherence to the intervention protocol), and any adverse reactions.
  • agitation severity (Behavioural Activity Rating Scale, Positive and Negative Syndrome Scale Excited Component), heart rate, emotional states (Mood scales derived from DSM-V), before and after listening to the playlist
  • agitation frequency (Cohen-Mansfield Agitation Inventory) and behavioral and psychological symptoms of dementia frequency (Neuropsychiatric Inventory- Questionnaire), at baseline and after 6 weeks
  1. Sample size:
  • 84 participants
  1. Randomization:
  • Participants will be randomly assigned to either intervention or control group at 1:1 ratio.
  1. Data analysis strategies:
  • Descriptive statistics will be used to report the feasibility indicators.
  • The treatment effect on agitation intensity, stress and mood as compared to control group before and after listening to music or control condition for 30 minutes during agitated state, will be analysed using Generalized Estimating Equation (GEE) method.
  • For evaluating the efficacy of music listening in reducing the occurrence frequency of agitation and other behavioural and psychological symptoms of dementia, the scores at baseline and post-intervention (i.e. after 6 weeks) between two groups will be analysed with Mixed ANOVA.
  • Significance level is set at p<.05 with 95% Confidence Interval.
  1. Ethical consideration:

Ethics approval will be obtained from the University before recruiting the participants. Proxies and participants will be informed about the possible risks and benefits of the participation, and it is voluntary and free to withdraw at any time. Procedural consent will be sought too.

Conditions
Dementia
Being tested
Music listening, Audio Book Listening
Keywords
Music, Agitation, Dementia, De-escalation
Medical subject headings
Dementia, Psychomotor Agitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music listeningBehavioural

    Other than usual care, subjects will listen to a 30-min individualized playlists with preferred music genres sequenced by a registered music therapist according to the ISO-Principle when agitated.

  • Audio Book ListeningBehavioural

    Other than usual care, subjects will listen to to a 30-min audio-script of book reading in Cantonese (a common dialect in Hong Kong being spoken by most people) when agitated.

Study groups in NCT04236557
Study groupRoleWhat they receive
InterventionExperimentalNot described
Receives: Behavioral: Music listening
Wait-list ControlPlacebo comparatorNot described
Receives: Behavioral: Audio Book Listening

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

    The percentage of eligible participants who finally agreed to join the project

    Measured: At baseline

  2. Attrition rate

    The percentage of recruited participant dropped out from the project prematurely

    Measured: The 6th week

  3. Satisfaction rate

    Satisfaction of the intervention rated by staff using self-developed rating scale

    Measured: At the end of the 6th week

Secondary outcomes (6)

  1. State of Arousal

    To be measured with Behavioural Activity Rating Scale (BARS): a single-item question indicating the condition of the participant in 7-point Likert-scale ranging from 1 - difficult or unable to rouse to 7 - violent, requires restraint. The inter-rater reliability was 0.999 and it is found sensitive in capturing the change of agitation after medication.

    Measured: During the 6-week study period, before and immediate after listening to the audio when agitated

  2. Mood States

    Mood scales derived from Diagnostic and Statistics Manual - Edition V. It consists of 16 items (8 items for negative mood and positive mood, respectively). with a 0-3 point rating on mood severity.

    the total score of subscale (negative and positive mood) will be calculated. Higher score refers to stronger mood observed.

    Measured: During the 6-week study period, before and immediate after listening to the audio when agitated

  3. Agitation frequency

    Cohen-Mansfield Agitation Inventory (CMAI) will be used.

    The CMAI is a caregivers' rating questionnaire consisting of 29 agitated behaviors, each rated on a 7-point scale of frequency. Ratings pertain to the two weeks preceding the administration of the CMAI.

    total score of sub-scale of three factors (Aggressive behaviour, physical non-agggressive behviour, and verbal agitted behaviours) will be calculated. A higher score means more frequent agitation.

    Measured: Screening, Baseline, at the end of the project (i.e. the 6th week)

  4. Behavioural and psychological symptoms of dementia frequency

    The behavioural and psychological symptoms of dementia frequency will be assessed with Neuropsychiatric Inventory Questionnaire (NPI-Q).

    It consists of 12 items covering the following domains: Hallucinations, Delusions, Agitation/aggression, Dysphoria/depression, Anxiety, Irritability, Disinhibition, Euphoria, Apathy, Aberrant motor behavior, Sleep and night-time behavior change, and Appetite and eating change. Each NPI-Q item is rated by the caregiver as 0-3 points according to levels of increasing severity and the score maximums are determined by multiplying the number of items by 3.

    Measured: Screening, Baseline, at the end of the project (i.e. the 6th week)

  5. Heart rate

    Will be measured with wearable sensor

    Measured: Continuously during the 6-week study period

  6. Agitation Intensity

    To be measured with Positive and Negative Syndrome Scale Excited Component (PANSS-EC). The PANSS-EC consists of 5 items: excitement, tension, hostility, uncooperativeness, and poor impulse control. The 5 items from the PANSS-EC are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores ≥ 20 clinically correspond to severe agitation. This set of items detects differences between drug and placebo when evaluating acute agitation and aggression in psychiatric patients [5,7-10] with different psychiatric pathologies.

    Measured: During the 6-week study period, before and immediate after listening to the audio when agitated

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2020
  2. Study start1 Nov 2022
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04236557
Sponsor's protocol ID
HSEARS20190731001
Status last verified
Sep 2023
First submitted
6 Dec 2019
Last updated
28 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Livingston G, Sommerlad A, Orgeta V, Costafreda SG, Huntley J, Ames D, Ballard C, Banerjee S, Burns A, Cohen-Mansfield J, Cooper C, Fox N, Gitlin LN, Howard R, Kales HC, Larson EB, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care. Lancet. 2017 Dec 16;390(10113):2673-2734. doi: 10.1016/S0140-6736(17)31363-6. Epub 2017 Jul 20. No abstract available.

    PubMed 28735855

  • Cummings J, Mintzer J, Brodaty H, Sano M, Banerjee S, Devanand DP, Gauthier S, Howard R, Lanctot K, Lyketsos CG, Peskind E, Porsteinsson AP, Reich E, Sampaio C, Steffens D, Wortmann M, Zhong K; International Psychogeriatric Association. Agitation in cognitive disorders: International Psychogeriatric Association provisional consensus clinical and research definition. Int Psychogeriatr. 2015 Jan;27(1):7-17. doi: 10.1017/S1041610214001963. Epub 2014 Oct 14.

    PubMed 25311499

  • Palm R, Sorg CGG, Strobel A, Gerritsen DL, Holle B. Severe Agitation in Dementia: An Explorative Secondary Data Analysis on the Prevalence and Associated Factors in Nursing Home Residents. J Alzheimers Dis. 2018;66(4):1463-1470. doi: 10.3233/JAD-180647.

    PubMed 30412491

  • Brimelow RE, Wollin JA, Byrne GJ, Dissanayaka NN. Prescribing of psychotropic drugs and indicators for use in residential aged care and residents with dementia. Int Psychogeriatr. 2019 Jun;31(6):837-847. doi: 10.1017/S1041610218001229. Epub 2018 Nov 20.

    PubMed 30457077

  • Hofmann H, Hahn S. Characteristics of nursing home residents and physical restraint: a systematic literature review. J Clin Nurs. 2014 Nov;23(21-22):3012-24. doi: 10.1111/jocn.12384. Epub 2013 Oct 11.

    PubMed 24125061

  • Cheng ST. Dementia Caregiver Burden: a Research Update and Critical Analysis. Curr Psychiatry Rep. 2017 Aug 10;19(9):64. doi: 10.1007/s11920-017-0818-2.

    PubMed 28795386

  • Zwijsen SA, Kabboord A, Eefsting JA, Hertogh CM, Pot AM, Gerritsen DL, Smalbrugge M. Nurses in distress? An explorative study into the relation between distress and individual neuropsychiatric symptoms of people with dementia in nursing homes. Int J Geriatr Psychiatry. 2014 Apr;29(4):384-91. doi: 10.1002/gps.4014. Epub 2013 Aug 20.

    PubMed 23963653

  • Morris S, Patel N, Baio G, Kelly L, Lewis-Holmes E, Omar RZ, Katona C, Cooper C, Livingston G. Monetary costs of agitation in older adults with Alzheimer's disease in the UK: prospective cohort study. BMJ Open. 2015 Mar 13;5(3):e007382. doi: 10.1136/bmjopen-2014-007382.

    PubMed 25770235

  • Dementia: Assessment, management and support for people living with dementia and their carers. London: National Institute for Health and Care Excellence (NICE); 2018 Jun. Available from http://www.ncbi.nlm.nih.gov/books/NBK513207/

    PubMed 30011160

  • Azermai M, Petrovic M, Elseviers MM, Bourgeois J, Van Bortel LM, Vander Stichele RH. Systematic appraisal of dementia guidelines for the management of behavioural and psychological symptoms. Ageing Res Rev. 2012 Jan;11(1):78-86. doi: 10.1016/j.arr.2011.07.002. Epub 2011 Aug 10.

    PubMed 21856452

  • Livingston G, Kelly L, Lewis-Holmes E, Baio G, Morris S, Patel N, Omar RZ, Katona C, Cooper C. Non-pharmacological interventions for agitation in dementia: systematic review of randomised controlled trials. Br J Psychiatry. 2014 Dec;205(6):436-42. doi: 10.1192/bjp.bp.113.141119.

    PubMed 25452601

  • van der Steen JT, Smaling HJ, van der Wouden JC, Bruinsma MS, Scholten RJ, Vink AC. Music-based therapeutic interventions for people with dementia. Cochrane Database Syst Rev. 2018 Jul 23;7(7):CD003477. doi: 10.1002/14651858.CD003477.pub4.

    PubMed 30033623

  • Pedersen SKA, Andersen PN, Lugo RG, Andreassen M, Sutterlin S. Effects of Music on Agitation in Dementia: A Meta-Analysis. Front Psychol. 2017 May 16;8:742. doi: 10.3389/fpsyg.2017.00742. eCollection 2017.

    PubMed 28559865

  • Jacobsen JH, Stelzer J, Fritz TH, Chetelat G, La Joie R, Turner R. Why musical memory can be preserved in advanced Alzheimer's disease. Brain. 2015 Aug;138(Pt 8):2438-50. doi: 10.1093/brain/awv135. Epub 2015 Jun 3.

    PubMed 26041611

  • Tsoi KKF, Chan JYC, Ng YM, Lee MMY, Kwok TCY, Wong SYS. Receptive Music Therapy Is More Effective than Interactive Music Therapy to Relieve Behavioral and Psychological Symptoms of Dementia: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2018 Jul;19(7):568-576.e3. doi: 10.1016/j.jamda.2017.12.009. Epub 2018 Feb 1.

    PubMed 29396186

Questions about this trial

What is this clinical trial studying?

A study testing Music listening and Audio Book Listening in people with Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04236557, which also lists 43 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

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