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Trial reportTrials2023

Statistical analysis plan for HOMESIDE: a randomised controlled trial for home-based family caregiver-delivered music and reading interventions for people living with dementia.

Vanessa Pac Soo, Felicity A Baker, Tanara Vieira Sousa, Helen Odell-Miller, Karette Stensæth, Thomas Wosch, Anna A Bukowska, Jeanette Tamplin, Nicola Lautenschlager, Sabine Braat and 1 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03907748 (HOMESIDE), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.7field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03907748 nacompletednot on this map

HOMESIDE: Home-based Family Caregiver-delivered Music and Reading Interventions for People Living With Dementia: A Randomised Controlled Trial

TypeinterventionalSponsorAnglia Ruskin UniversityRan2019 to 2022Enrolled864ConditionsDementia, Dementia, Vascular, Dementia With Lewy Bodies, Dementia, MixedArmsMusic Intervention, Reading Intervention
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 5 countries.

Vanessa Pac SooCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC, Australia. v.pacsoo@unimelb.edu.au.ORCID http://orcid.org/0000-0002-6276-6920
Felicity A BakerFaculty of Fine Arts and Music, The University of Melbourne, Melbourne, VIC, Australia.
Tanara Vieira SousaFaculty of Fine Arts and Music, The University of Melbourne, Melbourne, VIC, Australia.
Helen Odell-MillerCambridge Institute for Music Therapy Research, Anglia Ruskin University, Cambridge, UK.
Karette StensæthCentre for Research in Music and Health, Norwegian Academy of Music, Oslo, Norway.
Thomas WoschHochschule für angewandte Wissenschaften Würzburg-Schweinfurt, Würzburg, Germany.
Anna A BukowskaInstitute of Applied Sciences, University of Physical Education, Kraków, Poland.
Jeanette TamplinFaculty of Fine Arts and Music, The University of Melbourne, Melbourne, VIC, Australia.
Nicola LautenschlagerAcademic Unit for Psychiatry of Old Age, Department of Psychiatry, Melbourne Medical School, The University of Melbourne, Melbourne, VIC, Australia.
Sabine BraatCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC, Australia.
Karen E LambCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC, Australia.
The University of Melbourne · AUAnglia Ruskin University · GBNorwegian Academy of Music · NOTechnical University of Applied Sciences Würzburg-Schweinfurt · DEUniversity School of Physical Education in Kraków · PL

Funding

Federal Ministry of Education and Research Germany 01ED1901Joint Programs for Neurodegenerative Diseases and the National Health and Medical Research Council GNT1169867Norwegian Research Council 298995The National Centre for Research and Development at Alzheimer's Society, UK 462The National Centre for Research and Development, Poland JPND/04/2019
6 · The paper itself

Abstract

backgroundMost people with dementia live in the community, not in residential care. Therefore, quality informal care for them is critical for managing behavioural and psychological symptoms of dementia (BPSD). Music therapy has been shown to reduce BPSD. However, no randomised controlled trial has examined the effects of music interventions delivered by caregivers in home settings. The HOME-based caregiver-delivered music intervention for people living with dementia (HOMESIDE) trial aims to evaluate the effectiveness of a 12-week music intervention in addition to standard care for BPSD. This article describes the statistical analysis plan. METHODS AND ANALYSIS: HOMESIDE is a large, pragmatic international three-arm parallel-group randomised controlled trial. Dyads (persons with dementia and caregiver) in Australia, Germany, the UK, Poland and Norway were randomised to receive music and standard care, reading and standard care or standard care alone. The primary outcome is BPSD (proxy) of the person living with dementia, measured using the Neuropsychiatric Inventory-Questionnaire (NPI-Q) at 90 and 180 days post-randomisation. Longitudinal analysis will compare NPI-Q severity between music and standard care versus standard care alone. Secondary outcomes include quality of life and depression (both person with dementia and caregiver), cognition (person with dementia only), distress, resilience, competence and caregiver-patient relationship (caregiver only). Treatment effects will be obtained at 90 and 180 days post-randomisation, where applicable. Safety outcomes (adverse events, hospitalisations, deaths) will be summarised. DISCUSSION: This statistical analysis plan provides a detailed methodology for the analysis of HOMESIDE and will improve the validity of the study and reduce the potential for bias.

trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12618001799246. Registered on November 05, 2018. CLINICALTRIALS: gov NCT03907748. Registered on April 09, 2019.

Indexed as

DementiaMusicAustraliaCaregiversHumansQuality of LifeReadingDementiaMusic therapyRandomised controlled trialStatistical analysis plan

Identifiers

PMID37226214
PMCPMC10208194
OpenAlexW4378172493

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.