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

Abstract 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...

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Main Authors: Kirsty Sprange, Jules Beresford-Dent, Gail Mountain, Claire Craig, Clare Mason, Katherine Berry, Jessica Wright, Shazmin Majid, Ben Thomas, Cindy L. Cooper
Format: Article
Language:English
Published: BMC 2021-02-01
Series:BMC Geriatrics
Subjects:
Online Access:https://doi.org/10.1186/s12877-021-02070-8
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spelling doaj-175f92aca51640278be7ec5c886f943b2021-02-14T12:09:59ZengBMCBMC Geriatrics1471-23182021-02-0121111110.1186/s12877-021-02070-8Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trialKirsty Sprange0Jules Beresford-Dent1Gail Mountain2Claire Craig3Clare Mason4Katherine Berry5Jessica Wright6Shazmin Majid7Ben Thomas8Cindy L. Cooper9Nottingham Clinical Trials Unit, Faculty of Medicine, University of NottinghamUniversity of BradfordUniversity of BradfordSheffield Hallam UniversityUniversity of BradfordManchester Academic Health Science Centre, The University of ManchesterSheffield Clinical Trials Research Unit, School of Health and Related Research, University of SheffieldInstitute of Mental Health, Jubilee Campus, University of Nottingham Innovation ParkSheffield Clinical Trials Research Unit, School of Health and Related Research, University of SheffieldSheffield Clinical Trials Research Unit, School of Health and Related Research, University of SheffieldAbstract 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 .https://doi.org/10.1186/s12877-021-02070-8Complex interventionSelf-managementDementiaFidelity assessment
collection DOAJ
language English
format Article
sources DOAJ
author Kirsty Sprange
Jules Beresford-Dent
Gail Mountain
Claire Craig
Clare Mason
Katherine Berry
Jessica Wright
Shazmin Majid
Ben Thomas
Cindy L. Cooper
spellingShingle Kirsty Sprange
Jules Beresford-Dent
Gail Mountain
Claire Craig
Clare Mason
Katherine Berry
Jessica Wright
Shazmin Majid
Ben Thomas
Cindy L. Cooper
Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial
BMC Geriatrics
Complex intervention
Self-management
Dementia
Fidelity assessment
author_facet Kirsty Sprange
Jules Beresford-Dent
Gail Mountain
Claire Craig
Clare Mason
Katherine Berry
Jessica Wright
Shazmin Majid
Ben Thomas
Cindy L. Cooper
author_sort Kirsty Sprange
title Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial
title_short Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial
title_full Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial
title_fullStr Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial
title_full_unstemmed Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial
title_sort assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial
publisher BMC
series BMC Geriatrics
issn 1471-2318
publishDate 2021-02-01
description Abstract 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 .
topic Complex intervention
Self-management
Dementia
Fidelity assessment
url https://doi.org/10.1186/s12877-021-02070-8
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