Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: a randomised controlled trial

SPRANGE, Kirsty, MOUNTAIN, Gail and CRAIG, Claire (2021). Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: a randomised controlled trial. BMJ Open, 11 (4), e043478.

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Open Access URL: https://bmjopen.bmj.com/content/11/4/e043478.info (Published version)
Link to published version:: https://doi.org/10.1136/bmjopen-2020-043478
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    Abstract

    Objectives: Robust research of complex interventions designed to promote mental well-being in later life is required to inform service development. An essential component is ensuring that such interventions are delivered as intended. We present a detailed description of the design and implementation of a fidelity assessment within a trial of one such intervention (Lifestyle Matters). The findings help to explain the trial results and also inform the design of embedded fidelity assessments within future evaluations of complex interventions. Design: We conducted a mixed-method fidelity assessment embedded as part of a multicentre pragmatic randomised controlled trial. A conceptual fidelity framework was developed from the Behaviour Change Consortium framework. From this the fidelity assessment was designed. The resulting instrument assessed the following parameters: intervention design, training, supervision; and delivery, receipt and enactment of the intervention. Intervention: The Lifestyle Matters intervention was designed to assist older people to improve and sustain mental well-being through participation in meaningful activity. The aim is to enable participants to engage in both new and neglected activities through a mix of facilitated group meetings and individual sessions. Results: The fidelity assessment demonstrated that the intervention was delivered as per protocol for the group component and was tailored to meet individual needs. There was substantial inter-rater agreement for training; and group member performance 0.72; and moderate agreement for facilitator performance 0.55. It was not possible to determine whether small declines seen in facilitator performance were due to facilitator drift or moderating factors such as group dynamics or participant characteristics. Conclusions: The assessment methods adequately measured criteria identified as being significant indicators of fidelity. Adherence during training, delivery and supervision was good. The subjective nature of identification and rating observed behaviours was the main challenge. Future research should explore alternative methods of assessing fidelity in trials of complex interventions. Trial registration number: ISRCTN67209155.

    Item Type: Article
    Additional Information: ** Embargo end date: 07-04-2021 ** From BMJ via Jisc Publications Router ** Licence for this article starting on 07-04-2021: https://creativecommons.org/licenses/by/4.0/ **Journal IDs: eissn 2044-6055 **Article IDs: publisher-id: bmjopen-2020-043478 **History: published_online 07-04-2021; published 04-2021; accepted 24-03-2021; rev-recd 22-03-2021; submitted 04-08-2020
    Uncontrolled Keywords: Research methods, 1506, 1730, dementia, geriatric medicine, clinical trials
    Identification Number: https://doi.org/10.1136/bmjopen-2020-043478
    Page Range: e043478
    SWORD Depositor: Colin Knott
    Depositing User: Colin Knott
    Date Deposited: 13 Apr 2021 12:17
    Last Modified: 13 Apr 2021 12:30
    URI: http://shura.shu.ac.uk/id/eprint/28496

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