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

Wyman, Danielle Laura; Butler, Laurie; Cooper, Claudia; Bright, Peter; Morgan-Trimmer, Sarah; Barber, Julie; (2022) Process evaluation of the New Interventions for independence in Dementia Study (NIDUS) Family stream randomised controlled trial: protocol. BMJ Open , 12 (6) , Article e054613. 10.1136/bmjopen-2021-054613. Green open access

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Abstract

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.

Type: Article
Title: Process evaluation of the New Interventions for independence in Dementia Study (NIDUS) Family stream randomised controlled trial: protocol
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1136/bmjopen-2021-054613
Publisher version: http://dx.doi.org/10.1136/bmjopen-2021-054613
Language: English
Additional information: https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
Keywords: clinical trials, dementia, old age psychiatry, Alzheimer Disease, Caregivers, Dementia, Humans, Randomized Controlled Trials as Topic, Rivers, Surveys and Questionnaires
UCL classification: UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Maths and Physical Sciences
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Maths and Physical Sciences > Dept of Statistical Science
UCL > Provost and Vice Provost Offices > UCL BEAMS
UCL
URI: https://discovery.ucl.ac.uk/id/eprint/10150629
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