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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.
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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.
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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.
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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.
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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.
