Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial

Sprange, Kirsty; Beresford-Dent, Jules; Mountain, Gail; Craig, Claire; Mason, Clare; Berry, Katherine; Wright, Jessica; Majid, Shazmin; Thomas, Ben; Cooper, Cindy L.

Abstract

© 2021, The Author(s). Background: Understanding intervention delivery as intended, particularly in complex interventions, should be underpinned by good quality fidelity assessment. We present the findings from a fidelity assessment embedded as part of a trial of a complex community-based psychosocial intervention, Journeying through Dementia (JtD). The intervention was designed to equip individuals with the knowledge and skills to successfully self-manage, maintain independence, and live well with dementia and involves both group and individual sessions. The methodological challenges of developing a conceptual framework for fidelity assessment and creating and applying purposely designed measures derived from this framework are discussed to inform future studies. Methods: A conceptual fidelity framework was created out of core components of the intervention (including the intervention manual and training for delivery), associated trial protocols and pre-defined fidelity standards and criteria against which intervention delivery and receipt could be measured. Fidelity data collection tools were designed and piloted for reliability and usability. Data collection in four selected sites (fidelity sites) was via non-participatory observations of the group aspect of the intervention, attendance registers and interventionist (facilitator and supervisor) self-report. Results: Interventionists from all four fidelity sites attended intervention training. The majority of group participants at the four sites (71%) received the therapeutic dose of 10 out of 16 sessions. Weekly group meeting attendance (including at ‘out of venue’ sessions) was excellent at 80%. Additionally, all but one individual session was attended by the participants who completed the intervention. It proved feasible to create tools derived from the fidelity framework to assess in-venue group aspects of this complex intervention. Results of fidelity assessment of the observed groups were good with substantial inter-rater reliability between researchers KAPPA 0.68 95% CI (0.58–0.78). Self-report by interventionists concurred with researcher assessments. Conclusions: There was good fidelity to training and delivery of the group aspect of the intervention at four sites. However, the methodological challenges of assessing all aspects of this complex intervention could not be overcome due to practicalities, assessment methods and ethical considerations. Questions remain regarding how we can assess fidelity in community-based complex interventions without impacting upon intervention or trial delivery. Trial registration: ISRCTN17993825.

Citation

Sprange, K., Beresford-Dent, J., Mountain, G., Craig, C., Mason, C., Berry, K., …Cooper, C. L. (2021). Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial. BMC Geriatrics, 21(1), Article 119. https://doi.org/10.1186/s12877-021-02070-8

• Journal Article Type: Article
• Acceptance Date: Feb 2, 2021
• Online Publication Date: Feb 11, 2021
• Publication Date: Dec 1, 2021
• Deposit Date: Feb 15, 2021
• Publicly Available Date: Feb 15, 2021
• Journal: BMC Geriatrics
• Electronic ISSN: 1471-2318
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 21
• Issue: 1
• Article Number: 119
• DOI: https://doi.org/10.1186/s12877-021-02070-8
• Keywords: Geriatrics and Gerontology
• Public URL: https://nottingham-repository.worktribe.com/output/5319646
• Publisher URL: https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-021-02070-8
• Additional Information: Received: 25 November 2020; Accepted: 2 February 2021; First Online: 11 February 2021; : Ethical approval was obtained in July 2016 (ref no. 16/YH/0238) from the United Kingdom National Health Service Research Ethics. United Kingdom Health Research Authority approval was given (IRAS reference 199383) in August 2016. Participating sites gained permission from the local NHS Trust Research and Development Department prior to commencing research activities as a study site.; : We obtained written informed consent for the participants who took part in the interviews via the Trial Consent Form. This information is held as part of the archived record of the trial. Only anonymised nonidentifiable data are used in this report as per written consent.; : Clare Craig is the author of the Journeying through Dementia manual. All other authors declare no competing interests.