HOMESIDE: home-based family caregiver-delivered music and reading interventions for people living with dementia: protocol of a randomised controlled trial

Felicity Anne Baker, Jodie Bloska, Sabine Braat, Anna Bukowska, Imogen Clark, Ming H Hsu, Tone Kvamme, Nicola Lautenschlager, Young-Eun Claire Lee, Agnieszka Smrokowska-Reichmann, Tanara Vieira Sousa, Karette A Stensaeth, Jeanette Tamplin, Thomas Wosch, Helen Odell-Miller, Felicity Anne Baker, Jodie Bloska, Sabine Braat, Anna Bukowska, Imogen Clark, Ming H Hsu, Tone Kvamme, Nicola Lautenschlager, Young-Eun Claire Lee, Agnieszka Smrokowska-Reichmann, Tanara Vieira Sousa, Karette A Stensaeth, Jeanette Tamplin, Thomas Wosch, Helen Odell-Miller

Abstract

Introduction: Pharmacological interventions to address behavioural and psychological symptoms of dementia (BPSD) can have undesirable side effects, therefore non-pharmacological approaches to managing symptoms may be preferable. Past studies show that music therapy can reduce BPSD, and other studies have explored how formal caregivers use music in their caring roles. However, no randomised study has examined the effects on BPSD of music interventions delivered by informal caregivers (CGs) in the home setting. Our project aims to address the need for improved informal care by training cohabiting family CGs to implement music interventions that target BPSD, and the quality of life (QoL) and well-being of people with dementia (PwD) and CGs.

Methods and analysis: A large international three-arm parallel-group randomised controlled trial will recruit a sample of 495 dyads from Australia, Germany, UK, Poland and Norway. Dyads will be randomised equally to standard care (SC), a home-based music programme plus SC, or a home-based reading programme plus SC for 12 weeks. The primary outcome is BPSD of PwD (measured using the Neuropsychiatric Inventory-Questionnaire). Secondary outcomes will examine relationship quality between CG and PwD, depression, resilience, competence, QoL for CG and QoL for PwD. Outcomes will be collected at baseline, at the end of the 12-week intervention and at 6 months post randomisation. Resource Utilisation in Dementia will be used to collect economic data across the life of the intervention and at 6-month follow-up. We hypothesise that the music programme plus SC will generate better results than SC alone (primary comparison) and the reading programme plus SC (secondary comparison).

Ethics and dissemination: Ethical approval has been obtained for all countries. Results will be presented at national and international conferences and published in scientific journals and disseminated to consumer and caregiver representatives and the community.

Trial registration numbers: ACTRN12618001799246p; NCT03907748.

Keywords: behavioural and psychological symptoms of dementia; caregivers; dementia; home-based interventions; music therapy; randomised controlled trial.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Mechanisms of action underpinning the music intervention. BPSD, behavioural and psychological symptoms of dementia; CG, caregiver; MI, music intervention; PwD, people with dementia; QoL, quality of life.
Figure 2
Figure 2
HOMESIDE illustration of study design.
Figure 3
Figure 3
Schedule of enrolment, interventions and assessments. AQoL-6D, assessment of quality of life-6D instrument; EQ-5D-5L, the EuroQol instrument; ICD-10, 10th revision of the International Statistical Classification of Diseases and Related Health Problems; MADRS, Montgomery Asberg Depression Rating Scale; MI, music intervention; MMSE, Mini Mental State Examination Score; NPI-Q, Neuropsychiatric Inventory; PHQ-9, Patient Health Questionnaire-9; QALY, quality-adjusted life-years; QCPR, quality of caregiver-patient relationship; QoL-AD, quality of life-Alzheimer’s disease; RI, reading intervention; RS, Resilience Scale; RUD, resource utilisation in dementia; SSCQ, Short Sense of Competence Questionnaire.

References

    1. Livingston G, Sommerlad A, Orgeta V, et al. . Dementia prevention, intervention, and care. Lancet 2017;390:2673–734. 10.1016/S0140-6736(17)31363-6
    1. Papastavrou E, Kalokerinou A, Papacostas SS, et al. . Caring for a relative with dementia: family caregiver burden. J Adv Nurs 2007;58:446–57. 10.1111/j.1365-2648.2007.04250.x
    1. O'Dwyer S, Moyle W, van Wyk S. Suicidal ideation and resilience in family carers of people with dementia: a pilot qualitative study. Aging Ment Health 2013;17:753–60. 10.1080/13607863.2013.789001
    1. Li R, Cooper C, Austin A, et al. . Do changes in coping style explain the effectiveness of interventions for psychological morbidity in family carers of people with dementia? A systematic review and meta-analysis. Int. Psychogeriatr. 2013;25:204–14. 10.1017/S1041610212001755
    1. Piersol CV, Canton K, Connor SE, et al. . Effectiveness of interventions for caregivers of people with Alzheimer’s disease and related major neurocognitive disorders: A systematic review. Am J Occup Ther 2017;71:7105180020p1–7105180020. 10.5014/ajot.2017.027581
    1. de Vugt ME, Stevens F, Aalten P, et al. . Behavioural disturbances in dementia patients and quality of the marital relationship. Int J Geriatr Psychiatry 2003;18:149–54. 10.1002/gps.807
    1. National Institute for Health and Care Excellence NICE guidelines: dementia: assessment, management and support for people living with dementia and their carers, 2018. Available:
    1. Hsu MH, Flowerdew R, Parker M, et al. . Individual music therapy for managing neuropsychiatric symptoms for people with dementia and their carers: a cluster randomised controlled feasibility study. BMC Geriatr 2015;15:84 10.1186/s12877-015-0082-4
    1. Fusar-Poli L, Bieleninik Łucja, Brondino N, et al. . The effect of music therapy on cognitive functions in patients with dementia: a systematic review and meta-analysis. Aging Ment Health 2018;22:1103–12. 10.1080/13607863.2017.1348474
    1. Zhang Y, Cai J, An L, et al. . Does music therapy enhance behavioral and cognitive function in elderly dementia patients? A systematic review and meta-analysis. Ageing Res Rev 2017;35:1–11. 10.1016/j.arr.2016.12.003
    1. Ridder HMO, Stige B, Qvale LG, et al. . Individual music therapy for agitation in dementia: an exploratory randomized controlled trial. Aging Ment Health 2013;17:667–78. 10.1080/13607863.2013.790926
    1. Kitwood T. Dementia reconsidered: the person comes first. Buckingham, UK: Open University Press, 1997.
    1. Brooker D. Person-Centred dementia care: making services better. London: Jessica Kingsley Publishers, 2007.
    1. Baker F, Grocke D, Pachana N. Connecting through music: a study of a spousal carerCG-directed music intervention designed to prolong fulfilling relationships in couples where one person has dementia. Aust J Music Therapy 2012;23:4–19.
    1. Hanser SB, Butterfield-Whitcomb J, Kawata M, et al. . Home-based music strategies with individuals who have dementia and their family caregivers. J Music Ther 2011;48:2–27. 10.1093/jmt/48.1.2
    1. Jacobsen J-H, Stelzer J, Fritz TH, et al. . Why musical memory can be preserved in advanced Alzheimer’s disease. Brain 2015;138:2438–50. 10.1093/brain/awv135
    1. Longden E, Davis P, Carroll J, et al. . An evaluation of shared reading groups for adults living with dementia: preliminary findings. J Public Ment Health 2016;15:75–82. 10.1108/JPMH-06-2015-0023
    1. Kawashima R, Okita K, Yamazaki R, et al. . Reading Aloud and arithmetic calculation improve frontal function of people with dementia. J Gerontol A Biol Sci Med Sci 2005;60:380–4. 10.1093/gerona/60.3.380
    1. Vink AC, Birks JS, Bruinsma MS, et al. . Music therapy for people with dementia. Cochrane Database Syst Rev 2004;3:CD003477.
    1. Ray KD, Mittelman MS. Music therapy: a nonpharmacological approach to the care of agitation and depressive symptoms for nursing home residents with dementia. Dementia 2017;16:689–710. 10.1177/1471301215613779
    1. Aalbers S, Fusar-Poli L, Freeman RE, et al. . Music therapy for depression. Cochrane Database Syst Rev 2017;20 10.1002/14651858.CD004517.pub3
    1. van der Steen JT, van Soest-Poortvliet MC, van der Wouden JC, et al. . Music-based therapeutic interventions for people with dementia. Cochrane Database Syst Rev 2017;27 10.1002/14651858.CD003477.pub3
    1. Siafarikas N, Selbaek G, Fladby T, et al. . Frequency and subgroups of neuropsychiatric symptoms in mild cognitive impairment and different stages of dementia in Alzheimer's disease. Int Psychogeriatr 2018;30:103–13. 10.1017/S1041610217001879
    1. Baird A, Thompson WF. The impact of music on the self in dementia. J Alzheimers Dis 2018;61:827–41. 10.3233/JAD-170737
    1. Särkämö T, Tervaniemi M, Laitinen S, et al. . Cognitive, emotional, and social benefits of regular musical activities in early dementia: randomized controlled study. Gerontologist 2014;54:634–50. 10.1093/geront/gnt100
    1. Moniz-Cook E, Vernooij-Dassen M, Woods R, et al. . A European consensus on outcome measures for psychosocial intervention research in dementia care. Aging Ment Health 2008;12:14–29. 10.1080/13607860801919850
    1. Kaufer DI, Cummings JL, Ketchel P, et al. . Validation of the NPI-Q, a brief clinical form of the neuropsychiatric inventory. J Neuropsychiatry Clin Neurosci 2000;12:233–9. 10.1176/jnp.12.2.233
    1. Wong A, Cheng S-T, Lo ESK, et al. . Validity and reliability of the neuropsychiatric inventory questionnaire version in patients with stroke or transient ischemic attack having cognitive impairment. J Geriatr Psychiatry Neurol 2014;27:247–52. 10.1177/0891988714532017
    1. Fantino B, Moore N. The self-reported Montgomery-Åsberg depression rating scale is a useful evaluative tool in major depressive disorder. BMC Psychiatry 2009;9:26 10.1186/1471-244X-9-26
    1. Logsdon RG, Gibbons LE, McCurry SM, et al. . Assessing quality of life in older adults with cognitive impairment. Psychosom Med 2002;64:510–9. 10.1097/00006842-200205000-00016
    1. Thorgrimsen L, Selwood A, Spector A, et al. . Whose quality of life is it anyway: The validity and reliability of the Quality of Life-Alzheimer’s Disease scale. Alzheimer Dis Assoc Disor 2003;17:201–8.
    1. Pangman VC, Sloan J, Guse L. An examination of psychometric properties of the Mini-Mental state examination and the standardized Mini-Mental state examination: implications for clinical practice. Appl Nurs Res 2000;13:209–13. 10.1053/apnr.2000.9231
    1. Kroenke K, Spitzer RL, Williams JB, et al. . The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 2001;16:606–13.
    1. Cosco TD, Kaushal A, Richards M, et al. . Resilience measurement in later life: a systematic review and psychometric analysis. Health Qual Life Outcomes 2016;14 10.1186/s12955-016-0418-6
    1. Wagnild GM, Young HM. Development and psychometric evaluation of the resilience scale. J Nurs Meas 1993;1:165–78.
    1. Vernooij-Dassen MJFJ, Felling AJA, Brummelkamp E, et al. . Assessment of caregiver's competence in dealing with the burden of caregiving for a dementia patient: a Short Sense of Competence Questionnaire (SSCQ) suitable for clinical practice. J Am Geriatr Soc 1999;47:256–7. 10.1111/j.1532-5415.1999.tb04588.x
    1. Richardson JRJ, Peacock SJ, Hawthorne G, et al. . Construction of the descriptive system for the assessment of quality of life AQoL-6D utility instrument. Health Qual Life Outcomes 2012;10:38 10.1186/1477-7525-10-38
    1. Richardson J, Iezzi A, Khan MA, et al. . Cross-national comparison of twelve quality of life instruments: MIC paper 2 Australia. Victoria, Australia: Monash University, 2012.
    1. Spruytte N, Audenhove C, Lammertyn F, et al. . The quality of the caregiving relationship in informal care for older adults with dementia and chronic psychiatric patients. Psychol Psychother 2002;75:295–311. 10.1348/147608302320365208
    1. Herdman M, Gudex C, Lloyd A, et al. . Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011;20:1727–36. 10.1007/s11136-011-9903-x
    1. EuroQol Group EuroQol - a new facility for the measurement of health-related quality of life. Health Policy 1990;16:199–208. 10.1016/0168-8510(90)90421-9
    1. Orgeta V, Edwards RT, Hounsome B, et al. . The use of the EQ-5D as a measure of health-related quality of life in people with dementia and their carers. Qual Life Res 2015;24:315–24. 10.1007/s11136-014-0770-0
    1. Kunz S. Psychometric properties of the EQ-5D in a study of people with mild to moderate dementia. Qual Life Res 2010;19:425–34. 10.1007/s11136-010-9600-1
    1. Arons AMM, Krabbe PFM, Schölzel-Dorenbos CJM, et al. . Quality of life in dementia: a study on proxy bias. BMC Med Res Methodol 2013;13:110 10.1186/1471-2288-13-110
    1. Wimo A, Gustavsson A, Jönsson L, et al. . Application of Resource Utilization in Dementia (RUD) instrument in a global setting. Alzheimer's & Dementia 2013;9:429–35. 10.1016/j.jalz.2012.06.008
    1. Mao H-F, Kuo C-A, Huang W-N, et al. . Values of the minimal clinically important difference for the neuropsychiatric inventory questionnaire in individuals with dementia. J Am Geriatr Soc 2015;63:1448–52. 10.1111/jgs.13473
    1. Giebel CM, Sutcliffe C, Stolt M, et al. . Deterioration of basic activities of daily living and their impact on quality of life across different cognitive stages of dementia: a European study. Int. Psychogeriatr. 2014;26:1283–93. 10.1017/S1041610214000775
    1. Howard R, Phillips P, Johnson T, et al. . Determining the minimum clinically important differences for outcomes in the domino trial. Int J Geriatr Psychiatry 2011;26:812–7. 10.1002/gps.2607
    1. Liang Z, Zeger S. Longitudinal data analysis of continuous and discrete responses for prepost designs. The Indian Journal of Statistics 2000;62:134–48.
    1. Angrist JD, Imbens GW, Rubin DB. Identification of causal effects using instrumental variables. J Am Stat Assoc 1996;91:444–55. 10.1080/01621459.1996.10476902
    1. Harris PA, Taylor R, Thielke R, et al. . Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81. 10.1016/j.jbi.2008.08.010

Source: PubMed

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

3
Abonnere