Study protocol: randomised controlled hybrid type 2 trial evaluating the scale-up of two arts interventions for postnatal depression and Parkinson’s disease

Abstract

IntroductionResearch on the benefits of ‘arts’ interventions to improve individuals’ physical, social and psychological well-being is growing, but evidence on implementation and scale-up into health and social care systems is lacking. This protocol reports the SHAPER-Implement programme (Scale-up of Health-Arts Programmes Effectiveness-Implementation Research), aimed at studying the impact, implementation and scale-up of: Melodies for Mums (M4M), a singing intervention for postnatal depression; and Dance for Parkinson’s (PD-Ballet) a dance intervention for Parkinson’s disease. We examine how they could be embedded in clinical pathways to ensure their longer-term sustainability.Methods and analysisA randomised two-arm effectiveness-implementation hybrid type 2 trial design will be used across M4M/PD-Ballet. We will assess the implementation in both study arms (intervention vs control), and the cost-effectiveness of implementation. The design and measures, informed by literature and previous research by the study team, were refined through stakeholder engagement. Participants (400 in M4M; 160 in PD-Ballet) will be recruited to the intervention or control group (2:1 ratio). Further implementation data will be collected from stakeholders involved in referring to, delivering or supporting M4M/PD-Ballet (N=25–30 for each intervention).A mixed-methods approach (surveys and semi-structured interviews) will be employed. ‘Acceptability’ (measured by the ‘Acceptability Intervention Measure’) is the primary implementation endpoint for M4M/PD-Ballet. Relationships between clinical and implementation outcomes, implementation strategies (eg, training) and outcomes will be explored using generalised linear mixed models. Qualitative data will assess factors affecting the acceptability, feasibility and appropriateness of M4M/PD-Ballet, implementation strategies and longer-term sustainability. Costs associated with implementation and future scale-up will be estimated.Ethics and disseminationSHAPER-PND (the M4M trial) and SHAPER-PD (the PD trial) are approved by the West London and GTAC (20/PR/0813) and the HRA and Health and Care Research Wales (REC Reference: 20/WA/0261) Research Ethics Committees. Study findings will be disseminated through scientific peer-reviewed journals and scientific conferences.Trial registration numbersBoth trials are registered with NIH US National Library of Medicine, ClinicalTrials.gov. The trial registration numbers, URLs of registry records, and dates of registration are: (1) PD-Ballet: URL: NCT04719468 (https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fct2%2Fshow%2FNCT04719468%3Fterm%3DNCT04719468%26draw%3D2%26rank%3D1&data=04%7C01%7Crachel.davis%40kcl.ac.uk%7C11a7c5142782437919f808d903111449%7C8370cf1416f34c16b83c724071654356%7C0%7C0%7C6375441942616) (date of registration: 22 Jan 2021). (2) Melodies for Mums: NCT04834622 (https://clinicaltrials.gov/ct2/show/NCT04834622?term=shaper-pnd&draw=2&rank=1) (date of registration: 8 Apr 2021).

The PD-Ballet study: study protocol for a randomised controlled single-blind hybrid type 2 clinical trial evaluating the effects of ballet dancing on motor and non-motor symptoms in Parkinson’s disease

“…Separate consent will be sought for the implementation science data collection, as outlined in the implementation science study protocol [ 15 ].…”

“…The main trial objectives of the study are two-fold and given its hybrid type II model, the study has clinical effectiveness as well as implementation science as primary objectives which are outlined separately [ 15 ]. The primary objective for clinical effectiveness is to evaluate the effects of the interventions on the non-motor symptoms of PD, as defined by the change to the total score of the Movement Disorders Society-sponsored Non-Motor Scale (MDS-NMS) [ 16 ].…”

“…Study assessments will be carried out at baseline, end of the intervention and 3–6 months later, in accordance with participant availability. A separate Implementation science protocol has been published [ 15 ].…”

“…A parallel Implementation measures will be employed, as outlined in a separate study protocol [ 15 ].…”

“…As part of a wider project exploring the effects of art interventions in health, SHAPER [ 13 ], we propose a randomised controlled clinical trial investigating the effectiveness of ballet dancing as an adjuvant therapy in PD, as assessed by a range of validated clinical outcome measures and objective wearable sensors. The PD-Ballet study is a hybrid trial (type II, [ 14 ]) investigating both clinical effectiveness and implementation, and the current protocol manuscript will outline the clinical effectiveness evaluation; the implementation effectiveness evaluation is discussed in separate protocol [ 15 ].…”