IntroductionNew 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 analysisThe 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 disseminationEthical 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 numberISRCTN11425138.
Background: Psychosocial interventions improve the wellbeing and quality of life of People Living with Dementia (PLWD) and their family carers; but due to their complexity it can be challenging to identify mechanisms of action. We reviewed process evaluations that have sought to elucidate how these interventions work, to inform their implementation. Method:We systematically reviewed process evaluations of studies evaluating psychosocial interventions for PLWD in their own home and/or their family carers.We rated study quality using the Mixed Methods Appraisal Tool. We described, with reference to Medical Research Council (2015) process evaluation guidance, how implementation, mechanisms of impact and contextual factors were investigated; and describe commonalities in the mechanisms of action identified across studies. Results:Twenty four included studies evaluated the processes of 22 interventions.These studies collectively applied five frameworks; almost all frameworks' advised evaluations were theory-based and used mixed-methods analyses, but only 5/24 evaluation designs were informed by the intervention theory and 8/24 used mixed methods. 8/24 evaluations considered contextual factors in their design, though 20/ 24 cited contextual factors in findings. Interventions were more successful where PLWD were motivated and aware of potential benefits, and when carers could support engagement and were themselves supported by the intervention. How the intervention aligned with participants' current needs and stage of dementia were key influencing factors. Conclusion: Knowing how interventions can influence change for community-dwelling people with dementia and their family carer's will improve translation of trial findings into practice. Robust, theory-driven process evaluations can enable this.
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