Experiences of participant and public involvement in an international randomized controlled trial for people living with dementia and their informal caregivers.

BACKGROUND: This study was initiated and co-designed by a Participant and Public Involvement (PPI) group attached to HOMESIDE, a randomized controlled trial that investigated music and reading interventions for people living with dementia and their family caregivers across five countries: Australia, Germany, Norway, Poland, and the UK. The aim was to capture experiences of PPI across the five countries, explore the benefits and challenges of PPI in dementia research, and identify contributions made to the study. METHODS: We surveyed PPI members and academic researchers who collaborated on the HOMESIDE study. The survey was co-designed through consultation with PPI members and academics, alongside a small scoping literature review. Survey questions covered four topics: (1) expectations for PPI, (2) perceived contributions of PPI to the research study, (3) benefits and challenges of PPI, and (4) recommendations for future PPI in dementia research. RESULTS: There were 23 responses, representing 50% of the PPI members (n = 16) and 29% of academics (n = 7). PPI was found to be beneficial to the research and individuals involved. Contributions to the research included supporting recruitment and publicity, advising on the design of participant-facing materials, guiding the design and delivery of the interventions, and identifying cultural differences affecting research delivery. PPI members benefited from building connections, sharing experiences and receiving support, learning about dementia and research, and gaining new unexpected experiences. Academics learned about the realities of living with dementia, which they felt informed and grounded their work. Several challenges were identified, including the need for clear expectations and objectives, inconsistency of PPI members across research stages, limitations of meeting online versus in-person, scheduling difficulties, and language barriers. CONCLUSIONS: This study identifies important considerations for implementing PPI within dementia studies and international healthcare research more broadly. Our findings guided the development of five recommendations: (1) involve PPI members as early as possible and throughout the research process; (2) create a space for constructive criticism and feedback; (3) have clear tasks, roles, and expectations for PPI members; (4) involve PPI members with a diverse range of experiences and backgrounds; and (5) embed infrastructure and planning to support PPI.

Participant and Public Involvement (PPI) brings the knowledge of those with lived experience into research to improve research relevance and delivery. Our international study, called HOMESIDE, explored the benefits of music and reading activities for people with dementia and their family caregivers across five countries: Australia, Germany, Norway, Poland, and the UK. The study's PPI members included people with dementia, family carers, and healthcare professionals, who met regularly with the research team throughout the 3-year study. The current article reports the findings of a co-designed survey about PPI within HOMESIDE. Initiated by the HOMESIDE PPI members, we carried out a survey of PPI members and academics who worked on the study to learn about the unique experiences, perspectives, and contributions of PPI across the international research team.Our findings show that PPI helped to publicize the study, improved recruitment of research participants, and informed delivery of the interventions. Another important outcome was learning from each other; PPI members learned about dementia research and academics learned about the realities of living with dementia. However, the survey also highlighted challenges, including managing expectations, scheduling difficulties, and language barriers.To support PPI in future dementia research, we highlight five recommendations: (1) involve PPI members as early as possible and throughout the research process; (2) create a space for constructive criticism and feedback; (3) have clear tasks, roles, and expectations for PPI members; (4) involve PPI members with a diverse range of experiences and backgrounds; and (5) embed infrastructure and planning to support PPI.

The HOMESIDE Study-A Research Project to Support People Living With Dementia and Their Family Caregivers: Preliminary Report on Reading Intervention.

The behavioral and psychological symptoms of dementia (BPSD) can be challenging for family caregivers to cope with, leading to distress and fatigue. It is therefore important to offer effective strategies to reduce the impact of BPSD. The HOMESIDE randomized controlled trial (RCT) was testing purposefully developed interventions to improve the quality of life and wellbeing of dyads of people with dementia and family caregivers as a result of reduction of BPSD. HOMESIDE RCT was conducted in Australia, Germany, Norway, Poland and the United Kingdom between 2019 and 2022. The study design was a three-arm parallel-group single-blinded, pragmatic RCT with a sample size of 432 dyads. Dyads were randomly allocated to one of three treatment conditions: Music Intervention plus Standard Care; or Reading Intervention plus Standard Care; or Standard Care only. The Reading Intervention (RI) within the HOMESIDE RCT aimed to evoke shared discussion, reminiscence, meaningful shared experiences and consequently enrich everyday life, interaction and the emotional connection between the caregiver (CG) and carereceiver (CR); as well as to enhance activities of daily living and to promote relaxation or stimulation as appropriate. This paper describes the underlying conceptual framework, the content, and delivery of the Reading Intervention within the HOMESIDE RCT.

Home-based family caregiver-delivered music and reading interventions for people living with dementia (HOMESIDE trial): an international randomised controlled trial.

Background: Music interventions provided by qualified therapists within residential aged care are effective at attenuating behavioural and psychological symptoms (BPSD) of people with dementia (PwD). The impact of music interventions on dementia symptom management when provided by family caregivers is unclear. Methods: We implemented a community-based, large, pragmatic, international, superiority, single-masked randomised controlled trial to evaluate if caregiver-delivered music was superior to usual care alone (UC) on reducing BPSD of PwD measured by the Neuropsychiatric Inventory-Questionnaire (NPI-Q). The study included an active control (reading). People with dementia (NPI-Q score ≥6) and their caregiver (dyads) from one of five countries were randomly allocated to caregiver-delivered music, reading, or UC with a 1:1:1 allocation stratified by site. Caregivers received three online protocolised music or reading training sessions delivered by therapists and were recommended to provide five 30-min reading or music activities per week (minimum twice weekly) over 90-days. The NPI-Q severity assessment of PwD was completed online by masked assessors at baseline, 90- (primary) and 180-days post-randomisation and analysed on an intention-to-treat basis using a likelihood-based longitudinal data analysis model. ACTRN12618001799246; ClinicalTrials.govNCT03907748. Findings: Between 27th November 2019 and 7th July 2022, we randomised 432 eligible of 805 screened dyads (music n = 143, reading n = 144, UC n = 145). There was no statistical or clinically important difference in the change from baseline BPSD between caregiver-delivered music (-0.15, 95% CI -1.41 to 1.10, p = 0.81) or reading (-1.12, 95% CI -2.38 to 0.14, p = 0.082) and UC alone at 90-days. No related adverse events occurred. Interpretation: Our findings suggested that music interventions and reading interventions delivered by trained caregivers in community contexts do not decrease enduring BPSD symptoms. Funding: Our funding was provided by National Health and Medical Research Council, Australia; The Research Council of Norway; Federal Ministry of Education and Research, Germany; National Centre for Research and Development, Poland; Alzheimer's Society, UK, as part of the Joint Programme for Neurodegenerative Diseases consortia scheme.

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

BACKGROUND: Most 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 REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618001799246. Registered on November 05, 2018. CLINICALTRIALS: gov NCT03907748. Registered on April 09, 2019.

Recruitment approaches and profiles of consenting family caregivers and people living with dementia: A recruitment study within a trial.

Background: While studies have identified strategies that are useful for recruiting people living with dementia, none have focused on psychosocial interventions involving arts therapies, or have examined the profiles of older people living in the community who consent or decline participation, particularly during a global pandemic. We aimed to identify the most effective recruitment strategies according to participant characteristics and transnational differences and develop a profile of consenting and non-consenting participants. Methods: Recruitment teams in Australia, Norway, Germany, Poland, and the United Kingdom, recorded participants' source of study awareness and characteristics of consenting and non-consenting participants. Distributions of participants 'consenting to participate' were compared and logistic regressions were used to estimate the odds ratios. Results: Consenting female caregivers were disproportionally represented. Study awareness differed between countries but overall, most expressions of interest to participate were derived from referrals from professionals or organisations, or from databases of people wanting to participate in research. Troughs in recruitment rates occurred during Northern Hemisphere summer vacation periods, and during Christmas periods. Conclusions: This study found that recruiting for a trial with community-dwelling family caregivers and people living with dementia is challenging, especially during a global pandemic. While spousal caregivers comprised the highest proportion of dyads recruited, overall spousal caregivers were more reluctant to consent to participate than adult child caregivers. More targeted recruitment strategies designed for minority groups are also needed to ensure broader representation in dementia treatment studies.

The Influence of Home-Based Music Therapy Interventions on Relationship Quality in Couples Living with Dementia-An Adapted Convergent Mixed Methods Study.

Relationship quality is important for well-being and quality of life in couples living with dementia. Home-based music therapy interventions may be conducted with the aim of enhancing relationship quality. However, the effects or influences of such interventions are only briefly investigated in previous studies. This study's aim was to identify how a 12-week home-based music therapy intervention may influence relationship quality in couples living with dementia, through an adapted convergent mixed methods design. In this case, 68 participating couples from the HOMESIDE RCT study, and four individually recruited couples, received the music therapy intervention. Relationship quality for all participants was measured by the standardized Quality of Caregiver-Patient Relationship scale, and qualitative interviews were conducted with the four individually recruited participants at baseline and post intervention. Quantitative analysis indicated no statistically significant intervention effect. However, relationship quality remained stable over the intervention period. The qualitative analysis identified that the music therapy interventions primarily led to positive emotions, closeness, intimacy, and communication between the persons with dementia and their care partners. Intervention influences could also be ambiguous, as sharing music experiences might involve a risk of evoking vulnerabilities or negative emotional responses.

The HOMESIDE Music Intervention: A Training Protocol for Family Carers of People Living with Dementia.

Background: The number of people living with dementia (PwD) worldwide is expected to double every 20 years. Many continue living at home, receiving support from family caregivers who may experience significant stress, simultaneously to that of the PwD. Meaningful and effective home-based interventions to support PwD and their caregivers are needed. The development of a theory- and practice-driven online home-based music intervention (MI) is delivered by credentialed music therapists, nested within the HOMESIDE RCT trial. Methods: Dyads including the PwD and their family carer are randomised to MI, reading (RI) or standard care (SC). MI aims to support health wellbeing and quality of life by training caregivers to intentionally use music (singing, instrument playing, movement/dancing, and music listening) with their family member (PwD) in daily routines. MI is underpinned by cognitive, relational, social, and psychological theories of mechanisms of change. Results: Preliminary sub-cohort results analyses show MI can be delivered and is accepted well by participants and music-therapist interventionists across five countries. Conclusions: The specialist skills of a music therapist through MI enable carers to access music when music therapists are not present, to meet carer and PwD needs. Music therapists embrace this changing professional role, observing therapeutic change for members of the dyads.

Strategies for Recruiting People With Dementia to Music Therapy Studies: Systematic Review.

Positive effects of music therapy for people with dementia and their family carers are reported in a growing number of studies. However, small sample sizes or low recruitment rates often limit the success of these research studies. More adequately powered evidence-based studies are needed to impact policy and funding in dementia care. This systematic review examined recruitment strategies in music therapy clinical trials involving people living with dementia and/or their family carers. Eligible studies described enrolment, consent, accrual, or recruitment methods as well as recruitment or consent rates. Thirty studies with a total of 1,192 participants were included. Recruitment and conversion rates in residential aged care facilities (RACFs) (14 studies) were substantially higher than in community-based studies (16 studies). Whereas studies in RACFs most commonly recruited participants through staff approaching residents face-to-face or conversing with residents' legal guardians, community-based studies utilized a vast array of strategies, including staff referral, demonstrations/information sessions by researchers, advertisements, and direct contact with residents. Recruitment rates are likely to be higher when recruiters have an existing relationship with potential participants and when an independent third-party dementia organization is involved. Randomized controlled trials led to equally or greater recruitment conversion rates than other designs. Findings suggest that recruitment in dementia trials is complex, challenging, and needs thorough planning and consideration to be time- and cost-effective. Future studies should include reporting of recruitment strategies, enrolment rates, and related aspects so that researchers can better design recruitment strategies and estimate resources needed to reach the target sample size.

Neurologic Music Therapy Training for Mobility and Stability Rehabilitation with Parkinson's Disease - A Pilot Study.

Idiopathic Parkinson's Disease (PD) is a progressive condition with gait disturbance and balance disorder as the main symptoms. Previous research studies focused on the application of Rhythmic Auditory Stimulation (RAS) in PD gait rehabilitation. The key hypothesis of this pilot study, however, assumes the major role of the combination of all three Neurologic Music Therapy (NMT) sensorimotor techniques in improving spatio-temporal gait parameters, and postural stability in the course of PD. The 55 PD-diagnosed subjects invited to the study were divided into two groups: 30 in the experimental and 25 in the control group. Inclusion criteria included Hoehn and Yahr stages 2 or 3, the ability to walk independently without any aid and stable pharmacological treatment for the duration of the experiment. In order to evaluate the efficacy of the chosen therapy procedure the following measures were applied: Optoelectrical 3D Movement Analysis, System BTS Smart for gait, and Computerized Dynamic Posturography CQ Stab for stability and balance. All measures were conducted both before and after the therapy cycle. The subjects from the experimental group attended music therapy sessions four times a week for 4 weeks. Therapeutic Instrumental Music Performance (TIMP), Pattern Sensory Enhancement (PSE) and RAS were used in every 45-min session for practicing daily life activities, balance, pre-gait, and gait pattern. Percussion instruments, the metronome and rhythmic music were the basis for each session. The subjects from the control group were asked to stay active and perform daily life activities between the measures. The research showed that the combination of the three NMT sensorimotor techniques can be used to improve gait and other rhythmical activities in PD rehabilitation. The results demonstrated significant improvement in the majority of the spatiotemporal gait parameters in the experimental group in comparison to the control group. In the stability tests with eyes closed, substantial differences were revealed, indicating improvement of proprioception (the sense of body position and movement). These findings suggest a new compensatory strategy for movement and postural control through the use of the auditory system.