The PD COMM trial: a protocol for the process evaluation of a randomised trial assessing the effectiveness of two types of SLT for people with Parkinson’s disease

Autor: Pui Au, Christina H. Smith, Christopher R Burton, Marian C. Brady, Max Hughes, Avril Nicoll, Carl E Clarke, Catherine Sackley, Patricia Masterson-Algar, Caroline Rick
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Normalization process theory
Psychotherapist
Speech-Language Pathology
Time Factors
Voice Quality
media_common.quotation_subject
medicine.medical_treatment
government.form_of_government
Cost-Benefit Analysis
Applied psychology
Psychological intervention
Medicine (miscellaneous)
Fidelity
Process evaluation
law.invention
03 medical and health sciences
Study Protocol
0302 clinical medicine
Complex interventions
Randomized controlled trial
Clinical Protocols
law
medicine
Humans
Pharmacology (medical)
030212 general & internal medicine
media_common
Protocol (science)
lcsh:R5-920
Rehabilitation
Parkinson Disease
Health Care Costs
Recovery of Function
Speech and language therapy
Lee Silverman Voice Treatment
United Kingdom
Treatment Outcome
Voice Training
Research Design
government
Lee Silverman voice treatment
Psychology
lcsh:Medicine (General)
030217 neurology & neurosurgery
Incident report
Zdroj: Trials, Vol 18, Iss 1, Pp 1-8 (2017)
Masterson-Algar, P, Burton, C R, Brady, M C, Nicoll, A, Clarke, C E, Rick, C, Hughes, M, Au, P, Smith, C H & Sackley, C M 2017, ' The PD COMM trial : A protocol for the process evaluation of a randomised trial assessing the effectiveness of two types of SLT for people with Parkinson's disease ', Trials, vol. 18, no. 1, 397 . https://doi.org/10.1186/s13063-017-2130-1
Trials
ISSN: 1745-6215
Popis: Background The PD COMM trial is a phase III multi-centre randomised controlled trial whose aim is to evaluate the effectiveness and cost-effectiveness of two approaches to speech and language therapy (SLT) compared with no SLT intervention (control) for people with Parkinson’s disease who have self-reported or carer-reported problems with their speech or voice. Our protocol describes the process evaluation embedded within the outcome evaluation whose aim is to evaluate what happened at the time of the PD COMM intervention implementation and to provide findings that will assist in the interpretation of the PD COMM trial results. Furthermore, the aim of the PD COMM process evaluation is to investigate intervention complexity within a theoretical model of how the trialled interventions might work best and why. Methods/design Drawing from the Normalization Process Theory and frameworks for implementation fidelity, a mixed method design will be used to address process evaluation research questions. Therapists’ and participants’ perceptions and experiences will be investigated via in-depth interviews. Critical incident reports, baseline survey data from therapists, treatment record forms and home practice diaries also will be collected at relevant time points throughout the running of the PD COMM trial. Process evaluation data will be analysed independently of the outcome evaluation before the two sets of data are then combined. Discussion To date, there are a limited number of published process evaluation protocols, and few are linked to trials investigating rehabilitation therapies. Providing a strong theoretical framework underpinning design choices and being tailored to meet the complex characteristics of the trialled interventions, our process evaluation has the potential to provide valuable insight into which components of the interventions being delivered in PD COMM worked best (and what did not), how they worked well and why. Trial registration ISRCTN Registry, ISRCTN12421382. Registered on 18 April 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2130-1) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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