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Study protocol: randomised controlled hybrid type 2 trial evaluating the scale-up of two arts interventions for postnatal depression and Parkinson's disease.
Soukup, Tayana; Davis, Rachel E; Baldellou Lopez, Maria; Healey, Andy; Estevao, Carolina; Fancourt, Daisy; Dazzan, Paola; Pariante, Carmine; Dye, Hannah; Osborn, Tim; Bind, Rebecca; Sawyer, Kristi; Rebecchini, Lavinia; Hazelgrove, Katie; Burton, Alexandra; Manoharan, Manonmani; Perkins, Rosie; Podlewska, Aleksandra; Chaudhuri, Ray; Derbyshire-Fox, Fleur; Hartley, Alison; Woods, Anthony; Crane, Nikki; Bakolis, Ioannis; Sevdalis, Nick.
Afiliação
  • Soukup T; Centre Implementation Science, King's College London, London, UK.
  • Davis RE; Centre Implementation Science, King's College London, London, UK rachel.davis@kcl.ac.uk.
  • Baldellou Lopez M; Centre Implementation Science, King's College London, London, UK.
  • Healey A; Centre Implementation Science, King's College London, London, UK.
  • Estevao C; Department of Psychological Medicine, King's College London, London, UK.
  • Fancourt D; Department of Behavioural Science and Health, University College London, London, UK.
  • Dazzan P; Department of Psychological Medicine, King's College London, London, UK.
  • Pariante C; Department of Psychological Medicine, King's College London, London, UK.
  • Dye H; Breathe Arts Health Research, London, UK.
  • Osborn T; Breathe Arts Health Research, London, UK.
  • Bind R; Department of Psychological Medicine, King's College London, London, UK.
  • Sawyer K; Department of Psychological Medicine, King's College London, London, UK.
  • Rebecchini L; Department of Psychological Medicine, King's College London, London, UK.
  • Hazelgrove K; Department of Psychological Medicine, King's College London, London, UK.
  • Burton A; Department of Behavioural Science and Health, University College London, London, UK.
  • Manoharan M; South London and Maudsley NHS Foundation Trust, London, UK.
  • Perkins R; Faculty of Medicine, Imperial College London, London, UK.
  • Podlewska A; Centre for Performance Science, Royal College of Music, London, UK.
  • Chaudhuri R; Department of Basic and Clinical Neuroscience, King's College London, London, UK.
  • Derbyshire-Fox F; Department of Basic and Clinical Neuroscience, King's College London, London, UK.
  • Hartley A; English National Ballet, London, UK.
  • Woods A; English National Ballet, London, UK.
  • Crane N; Department of Psychological Medicine, King's College London, London, UK.
  • Bakolis I; Department of Psychological Medicine, King's College London, London, UK.
  • Sevdalis N; Centre Implementation Science, King's College London, London, UK.
BMJ Open ; 12(2): e055691, 2022 Feb 01.
Article em En | MEDLINE | ID: mdl-35105591
INTRODUCTION: Research 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 ANALYSIS: A 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 DISSEMINATION: SHAPER-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 NUMBERS: Both 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).
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Texto completo: 1 Coleções: 01-internacional Contexto em Saúde: 1_ASSA2030 Base de dados: MEDLINE Assunto principal: Doença de Parkinson / Depressão Pós-Parto / Canto Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies / Qualitative_research Aspecto: Ethics Limite: Female / Humans Idioma: En Revista: BMJ Open Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Contexto em Saúde: 1_ASSA2030 Base de dados: MEDLINE Assunto principal: Doença de Parkinson / Depressão Pós-Parto / Canto Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies / Qualitative_research Aspecto: Ethics Limite: Female / Humans Idioma: En Revista: BMJ Open Ano de publicação: 2022 Tipo de documento: Article