Clinical trial NCT04236557: Individualized Music Playlist Based on ISO-Principle for De-escalating Agitation of People Living With Dementia
Official title: Individualized Music Playlist Based on ISO-Principle for De-escalating Agitation of People Living With Dementia: A Randomized Controlled Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Music
Agitation
Dementia
De-escalation
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

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.

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:
   1. To evaluate the feasibility of the intervention in terms of recruitment, retention, and acceptability.
   2. To examine the preliminary effects of the intervention on participants' agitation, stress and emotion as compared to control group.
   3. To evaluate suitability of outcome assessment instruments.
2. Methods:

   1. Design:

      * A two arms randomized controlled feasibility trial.
   2. Participants and setting:

      * The study participants will be recruited from participating residential care homes for the elderly in Hong Kong.
   3. 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.
   4. 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.
   5. 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
   6. Sample size:

      * 84 participants
   7. Randomization:

      * Participants will be randomly assigned to either intervention or control group at 1:1 ratio.
   8. 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.
   9. 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.

Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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

Primary outcomes:
measure: Recruitment rate
timeFrame: At baseline
measure: Attrition rate
timeFrame: The 6th week
measure: Satisfaction rate
timeFrame: At the end of the 6th week
Secondary outcomes:
measure: State of Arousal
timeFrame: During the 6-week study period, before and immediate after listening to the audio when agitated
measure: Mood States
timeFrame: During the 6-week study period, before and immediate after listening to the audio when agitated
measure: Agitation frequency
timeFrame: Screening, Baseline, at the end of the project (i.e. the 6th week)
measure: Behavioural and psychological symptoms of dementia frequency
timeFrame: Screening, Baseline, at the end of the project (i.e. the 6th week)
measure: Heart rate
timeFrame: Continuously during the 6-week study period
measure: Agitation Intensity
timeFrame: During the 6-week study period, before and immediate after listening to the audio when agitated
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The Hong Kong Polytechnic University
Study officials:
affiliation: School of Nursing, The Hong Kong Polytechnic University
name: Daphne Sze Ki Cheung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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/
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Vasionyte I, Madison G. Musical intervention for patients with dementia: a meta-analysis. J Clin Nurs. 2013 May;22(9-10):1203-16. doi: 10.1111/jocn.12166.
citation: Cheung DSK, Lai CKY, Wong FKY, Leung MCP. Is music-with-movement intervention better than music listening and social activities in alleviating agitation of people with moderate dementia? A randomized controlled trial. Dementia (London). 2020 Jul;19(5):1413-1425. doi: 10.1177/1471301218800195. Epub 2018 Sep 20.
citation: Gaviola MA, Inder KJ, Dilworth S, Holliday EG, Higgins I. Impact of individualised music listening intervention on persons with dementia: A systematic review of randomised controlled trials. Australas J Ageing. 2020 Mar;39(1):10-20. doi: 10.1111/ajag.12642. Epub 2019 Mar 26.
citation: Music & Memory. Impact report. New York.: Music & Memory;2017.
citation: Garrido S, Dunne L, Chang E, Perz J, Stevens CJ, Haertsch M. The Use of Music Playlists for People with Dementia: A Critical Synthesis. J Alzheimers Dis. 2017;60(3):1129-1142. doi: 10.3233/JAD-170612.
citation: Gerdner LA. Individualized music for dementia: Evolution and application of evidence-based protocol. World J Psychiatry. 2012 Apr 22;2(2):26-32. doi: 10.5498/wjp.v2.i2.26.
citation: McDermott O, Crellin N, Ridder HM, Orrell M. Music therapy in dementia: a narrative synthesis systematic review. Int J Geriatr Psychiatry. 2013 Aug;28(8):781-94. doi: 10.1002/gps.3895. Epub 2012 Oct 18.
citation: Thoma MV, Zemp M, Kreienbuhl L, Hofer D, Schmidlin PR, Attin T, Ehlert U, Nater UM. Effects of Music Listening on Pre-treatment Anxiety and Stress Levels in a Dental Hygiene Recall Population. Int J Behav Med. 2015 Aug;22(4):498-505. doi: 10.1007/s12529-014-9439-x.
citation: Brown S, Martinez MJ, Parsons LM. Passive music listening spontaneously engages limbic and paralimbic systems. Neuroreport. 2004 Sep 15;15(13):2033-7. doi: 10.1097/00001756-200409150-00008.
citation: Hammar LM, Emami A, Gotell E, Engstrom G. The impact of caregivers' singing on expressions of emotion and resistance during morning care situations in persons with dementia: an intervention in dementia care. J Clin Nurs. 2011 Apr;20(7-8):969-78. doi: 10.1111/j.1365-2702.2010.03386.x. Epub 2011 Feb 10.
citation: Hammar LM, Emami A, Engstrom G, Gotell E. Communicating through caregiver singing during morning care situations in dementia care. Scand J Caring Sci. 2011 Mar;25(1):160-8. doi: 10.1111/j.1471-6712.2010.00806.x.
citation: Ray KD, Fitzsimmons S. Music-assisted bathing: making shower time easier for people with dementia. J Gerontol Nurs. 2014 Feb;40(2):9-13. doi: 10.3928/00989134-20131220-09. Epub 2014 Jan 6.
citation: Wigram T. A comprehensive guide to music therapy : theory, clinical practice, research, and training. London: Jessica Kingsley Publishers; 2002.
citation: Altshuler IM. FOUR YEARS'EXPERIENCE WITH MUSIC AS A THERAPEUTIC AGENT AT ELOISE HOSPITAL. American Journal of Psychiatry. 1944;100(7):792-794.
citation: Cadwalader A, Orellano S, Tanguay C, Roshan R. The Effects of a Single Session of Music Therapy on the Agitated Behaviors of Patients Receiving Hospice Care. J Palliat Med. 2016 Aug;19(8):870-3. doi: 10.1089/jpm.2015.0503. Epub 2016 Apr 26.
citation: Yuen I, Kwok T. Effectiveness of DementiAbility Methods: The Montessori Way on agitation in long-term care home residents with dementia in Hong Kong. Int J Geriatr Psychiatry. 2019 Sep;34(9):1352-1358. doi: 10.1002/gps.5063. Epub 2019 Mar 1.
citation: Baker RW, Kinon BJ, Maguire GA, Liu H, Hill AL. Effectiveness of rapid initial dose escalation of up to forty milligrams per day of oral olanzapine in acute agitation. J Clin Psychopharmacol. 2003 Aug;23(4):342-8. doi: 10.1097/01.jcp.0000085406.08426.a8.
citation: Kales HC, Gitlin LN, Lyketsos CG. Assessment and management of behavioral and psychological symptoms of dementia. BMJ. 2015 Mar 2;350:h369. doi: 10.1136/bmj.h369.
citation: Swift RH, Harrigan EP, Cappelleri JC, Kramer D, Chandler LP. Validation of the behavioural activity rating scale (BARS): a novel measure of activity in agitated patients. J Psychiatr Res. 2002 Mar-Apr;36(2):87-95. doi: 10.1016/s0022-3956(01)00052-8.
citation: Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.
citation: Montoya A, Valladares A, Lizan L, San L, Escobar R, Paz S. Validation of the Excited Component of the Positive and Negative Syndrome Scale (PANSS-EC) in a naturalistic sample of 278 patients with acute psychosis and agitation in a psychiatric emergency room. Health Qual Life Outcomes. 2011 Mar 29;9:18. doi: 10.1186/1477-7525-9-18.
citation: Melander C, Martinsson J, Gustafsson S. Measuring Electrodermal Activity to Improve the Identification of Agitation in Individuals with Dementia. Dement Geriatr Cogn Dis Extra. 2017 Dec 6;7(3):430-439. doi: 10.1159/000484890. eCollection 2017 Sep-Dec.
citation: Kikhia B, Stavropoulos TG, Andreadis S, Karvonen N, Kompatsiaris I, Savenstedt S, Pijl M, Melander C. Utilizing a Wristband Sensor to Measure the Stress Level for People with Dementia. Sensors (Basel). 2016 Nov 24;16(12):1989. doi: 10.3390/s16121989.
citation: Schroeder RW, Martin PK, Marsh C, Carr S, Richardson T, Kaur J, Rusk J, Jiwanlal S. An Individualized Music-Based Intervention for Acute Neuropsychiatric Symptoms in Hospitalized Older Adults With Cognitive Impairment: A Prospective, Controlled, Nonrandomized Trial. Gerontol Geriatr Med. 2018 Jun 21;4:2333721418783121. doi: 10.1177/2333721418783121. eCollection 2018 Jan-Dec.
citation: Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a nursing home. J Gerontol. 1989 May;44(3):M77-84. doi: 10.1093/geronj/44.3.m77.
citation: Kaufer DI, Cummings JL, Ketchel P, Smith V, MacMillan A, Shelley T, Lopez OL, DeKosky ST. Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric Inventory. J Neuropsychiatry Clin Neurosci. 2000 Spring;12(2):233-9. doi: 10.1176/jnp.12.2.233.
citation: Teare MD, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials. 2014 Jul 3;15:264. doi: 10.1186/1745-6215-15-264.
citation: Jung SH, Ahn CW. Sample size for a two-group comparison of repeated binary measurements using GEE. Stat Med. 2005 Sep 15;24(17):2583-96. doi: 10.1002/sim.2136.