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Trials
Published in: Trials 1/2022

01-12-2022 | Stroke | Research

Treatment fidelity monitoring, reporting and findings in a complex aphasia intervention trial: a substudy of the Very Early Rehabilitation in SpEech (VERSE) trial

Authors: Erin Godecke, Emily Brogan, Natalie Ciccone, Miranda L. Rose, Elizabeth Armstrong, Anne Whitworth, Fiona Ellery, Audrey Holland, Sandy Middleton, Tapan Rai, Graeme J. Hankey, Dominique Cadilhac, Julie Bernhardt

Published in: Trials | Issue 1/2022

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Abstract

Background

Treatment fidelity is inconsistently reported in aphasia research, contributing to uncertainty about the effectiveness of types of aphasia therapy following stroke. We outline the processes and outcomes of treatment fidelity monitoring in a pre-specified secondary analysis of the VERSE trial.

Methods

VERSE was a 3-arm, single-blinded RCT with a 12-week primary endpoint comparing Usual Care (UC) to two higher intensity treatments: Usual Care-Plus (UC-Plus) and VERSE, a prescribed intervention. Primary outcome results were previously reported. This secondary analysis focused on treatment fidelity. Video-recorded treatment sessions in the higher intensity study arms were evaluated for treatment adherence and treatment differentiation. Treatment components were evaluated using a pre-determined fidelity checklist. Primary outcome: prescribed amount of therapy time (minutes); secondary outcomes: (i) adherence to therapy protocol (%) and (ii) treatment differentiation between control and high intensity groups.

Results

Two hundred forty-six participants were randomised to Usual Care (n=81), Usual Care-Plus (n=82), and VERSE (n=83). One hundred thirty-five (82%) participants in higher intensity intervention arms received the minimum prescribed therapy minutes. From 10,805 (UC 7787; UC-Plus 1450; VERSE 1568) service events, 431 treatment protocol deviations were noted in 114 participants. Four hundred thirty-seven videos were evaluated. The VERSE therapists achieved over 84% adherence to key protocol elements. Higher stroke and aphasia severity, older age, and being in the UC-Plus group predicted more treatment deviations.

Conclusions

We found high levels of treatment adherence and differentiation between the intervention arms, providing greater confidence interpreting our results. The comprehensive systems for intervention fidelity monitoring and reporting in this trial make an important contribution to aphasia research and, we argue, should set a new standard for future aphasia studies.

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Appendix
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Metadata
Title
Treatment fidelity monitoring, reporting and findings in a complex aphasia intervention trial: a substudy of the Very Early Rehabilitation in SpEech (VERSE) trial
Authors
Erin Godecke
Emily Brogan
Natalie Ciccone
Miranda L. Rose
Elizabeth Armstrong
Anne Whitworth
Fiona Ellery
Audrey Holland
Sandy Middleton
Tapan Rai
Graeme J. Hankey
Dominique Cadilhac
Julie Bernhardt
Publication date
01-12-2022
Publisher
BioMed Central
Keywords
Stroke
Aphasia
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06433-3

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