Introduction Treatment fidelity is a complex, multifaceted evaluative process which refers to whether a studied intervention was delivered as intended. Monitoring and enhancing fidelity is one recommendation of the TiDIER (Template for Intervention Description and Replication) checklist, as fidelity can inform interpretation and conclusions drawn about treatment effects. Despite the methodological and translational benefits, fidelity strategies have been used inconsistently within health behaviour intervention studies; in particular, within aphasia intervention studies, reporting of fidelity remains relatively rare. This paper describes the development of a fidelity protocol for the Action Success Knowledge (ASK) study, a current cluster randomised trial investigating an early mood intervention for people with aphasia (a language disability caused by stroke).
Methods and analysis A novel fidelity protocol and tool was developed to monitor and enhance fidelity within the two arms (experimental treatment and attention control) of the ASK study. The ASK fidelity protocol was developed based on the National Institutes of Health Behaviour Change Consortium fidelity framework.
Ethics and dissemination The study protocol was approved by the Darling Downs Hospital and Health Service Human Research Ethics Committee in Queensland, Australia under the National Mutual Acceptance scheme of multicentre human research projects. Specific ethics approval was obtained for those participating sites who were not under the National Mutual Agreement at the time of application. The monitoring and ongoing conduct of the research project is in line with requirements under the National Mutual Acceptance. On completion of the trial, findings from the fidelity reviews will be disseminated via publications and conference presentations.
Trial registration number ACTRN12614000979651.
- clinical trial
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Contributors LW is the chief investigator for the study and assembled the team. All authors contributed to study design. IK oversaw the development of the fidelity protocol. As trial managers for this study, BR and MC led staff training and monitored videos submitted for fidelity review. MC wrote the fidelity protocol with input from IK, BR, ST, LW, NS-M, MR, LT and TCH. MC wrote the draft manuscript; all authors (BR, LW, ST, MR, NS-M, AK, TH, EP, LT, IK) contributed to manuscript revision and approved the final manuscript for submission.
Funding This research was funded by a grant from the National Health and Medical Research Council Project from 2014 to 2018 (APP1060673).
Competing interests None declared.
Ethics approval The study protocol was approved by the Darling Downs Hospital and Health Service Human Research Ethics Committee (HREC) in Queensland, Australia under the National Mutual Acceptance scheme of multicentre human research projects conducted in publicly funded health services. Based on this approval, expedited approval for the study was granted by the University of Queensland. Ethics approval was also obtained for participating sites not approved under the National Mutual Agreement scheme at the time of application.
Provenance and peer review Not commissioned; externally peer reviewed.
Patient consent for publication Not required.
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