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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Patricia Masterson-Algar, Christopher R. Burton, Marian C. Brady, Avril Nicoll, Carl E. Clarke, Caroline Rick, Max Hughes, Pui Au, Christina H. Smith, Catherine M. Sackley

Published in: Trials | Issue 1/2017

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Abstract

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.
Appendix
Available only for authorised users
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Metadata
Title
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
Authors
Patricia Masterson-Algar
Christopher R. Burton
Marian C. Brady
Avril Nicoll
Carl E. Clarke
Caroline Rick
Max Hughes
Pui Au
Christina H. Smith
Catherine M. Sackley
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2130-1

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