Process evaluation of the New Interventions for independence in Dementia Study (NIDUS) Family stream randomised controlled trial: protocol

Introduction New Interventions for independence in Dementia Study (NIDUS)-Family is an Alzheimer’s Society funded new manualised, multimodal psychosocial intervention to support people living with dementia (PLWD) to achieve goals that they and their family carers set, towards living as independently...

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Main Authors: Julie Barber, Laurie Butler, Claudia Cooper, Sarah Morgan-Trimmer, Danielle Laura Wyman, Peter Bright
Format: Article
Language:English
Published: BMJ Publishing Group 2022-06-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/12/6/e054613.full
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author Julie Barber
Laurie Butler
Claudia Cooper
Sarah Morgan-Trimmer
Danielle Laura Wyman
Peter Bright
author_facet Julie Barber
Laurie Butler
Claudia Cooper
Sarah Morgan-Trimmer
Danielle Laura Wyman
Peter Bright
author_sort Julie Barber
collection DOAJ
description Introduction New Interventions for independence in Dementia Study (NIDUS)-Family is an Alzheimer’s Society funded new manualised, multimodal psychosocial intervention to support people living with dementia (PLWD) to achieve goals that they and their family carers set, towards living as independently and as well as possible at home for longer. This process evaluation will be embedded within the NIDUS-Family Randomised Controlled Trial intervention-arm (n=199), testing how the intervention influences change, as measured by goal attainment. The evaluation will test, refine and develop the NIDUS-Family theoretical model, associated causal assumptions and logic model to identify key mechanisms of impact, implementation and contextual factors influencing the intervention’s effectiveness. Findings will inform how the programme is implemented in practice.Methods and analysis The process evaluation will be theory driven and apply a convergent mixed-methods design. Dyads (PLWD and family carer) will be purposively sampled based on high or low Goal Attainment Scaling scores (trial primary outcome). Qualitative interviews with dyads (approx. n=30) and their respective facilitators post-trial will explore their experiences of receiving and delivering the intervention. Interviews will be iteratively thematically analysed. Matching observational quantitative data will be collected concurrently from videorecordings and/or audiorecordings of NIDUS-Family dyad trial sessions. Further quantitative data will be collected through an acceptability questionnaire for all intervention-arm dyads (n=199). Mixed-method integration will use an interactive analysis strategy, considering qualitative and quantitative findings through mixed-method matrix for dyadic level ‘case studies’, and a joint display for ‘population’ level analysis and interpretation.Ethics and dissemination Ethical approval was received from Camden & Kings Cross Research Ethics Committee (REC). Study reference: 19/LO/1667. IRAS project ID: 271 363. This work is carried out within the UCL Alzheimer’s Society Centre of Excellence (grant 300) for Independence at home, NIDUS programme.Findings will be disseminated through publications and conferences, and as recommendations for the implementation study and strategy.Trial registration number ISRCTN11425138.
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spelling doaj-art-9ab766ac0b96408ca41e6643c064dde62025-01-28T13:00:12ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-054613Process evaluation of the New Interventions for independence in Dementia Study (NIDUS) Family stream randomised controlled trial: protocolJulie Barber0Laurie Butler1Claudia Cooper2Sarah Morgan-Trimmer3Danielle Laura Wyman4Peter Bright5Department of Statistical Science, University College London, London, UK3 Centre for Health Performance and Wellbeing, Anglia Ruskin University, Cambridge, UK9 East London NHS Foundation Trust, London, UK3 Department of Health and Community Sciences, University of Exeter Faculty of Health and Life Sciences, Exeter, UKFaculty of Science and Engineering, Anglia Ruskin University - Cambridge Campus, Cambridge, UKPsychology, Anglia Ruskin University - Cambridge Campus, Cambridge, UKIntroduction New Interventions for independence in Dementia Study (NIDUS)-Family is an Alzheimer’s Society funded new manualised, multimodal psychosocial intervention to support people living with dementia (PLWD) to achieve goals that they and their family carers set, towards living as independently and as well as possible at home for longer. This process evaluation will be embedded within the NIDUS-Family Randomised Controlled Trial intervention-arm (n=199), testing how the intervention influences change, as measured by goal attainment. The evaluation will test, refine and develop the NIDUS-Family theoretical model, associated causal assumptions and logic model to identify key mechanisms of impact, implementation and contextual factors influencing the intervention’s effectiveness. Findings will inform how the programme is implemented in practice.Methods and analysis The process evaluation will be theory driven and apply a convergent mixed-methods design. Dyads (PLWD and family carer) will be purposively sampled based on high or low Goal Attainment Scaling scores (trial primary outcome). Qualitative interviews with dyads (approx. n=30) and their respective facilitators post-trial will explore their experiences of receiving and delivering the intervention. Interviews will be iteratively thematically analysed. Matching observational quantitative data will be collected concurrently from videorecordings and/or audiorecordings of NIDUS-Family dyad trial sessions. Further quantitative data will be collected through an acceptability questionnaire for all intervention-arm dyads (n=199). Mixed-method integration will use an interactive analysis strategy, considering qualitative and quantitative findings through mixed-method matrix for dyadic level ‘case studies’, and a joint display for ‘population’ level analysis and interpretation.Ethics and dissemination Ethical approval was received from Camden & Kings Cross Research Ethics Committee (REC). Study reference: 19/LO/1667. IRAS project ID: 271 363. This work is carried out within the UCL Alzheimer’s Society Centre of Excellence (grant 300) for Independence at home, NIDUS programme.Findings will be disseminated through publications and conferences, and as recommendations for the implementation study and strategy.Trial registration number ISRCTN11425138.https://bmjopen.bmj.com/content/12/6/e054613.full
spellingShingle Julie Barber
Laurie Butler
Claudia Cooper
Sarah Morgan-Trimmer
Danielle Laura Wyman
Peter Bright
Process evaluation of the New Interventions for independence in Dementia Study (NIDUS) Family stream randomised controlled trial: protocol
BMJ Open
title Process evaluation of the New Interventions for independence in Dementia Study (NIDUS) Family stream randomised controlled trial: protocol
title_full Process evaluation of the New Interventions for independence in Dementia Study (NIDUS) Family stream randomised controlled trial: protocol
title_fullStr Process evaluation of the New Interventions for independence in Dementia Study (NIDUS) Family stream randomised controlled trial: protocol
title_full_unstemmed Process evaluation of the New Interventions for independence in Dementia Study (NIDUS) Family stream randomised controlled trial: protocol
title_short Process evaluation of the New Interventions for independence in Dementia Study (NIDUS) Family stream randomised controlled trial: protocol
title_sort process evaluation of the new interventions for independence in dementia study nidus family stream randomised controlled trial protocol
url https://bmjopen.bmj.com/content/12/6/e054613.full
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