Faculty of Science and Engineering, Anglia Ruskin University - Cambridge Campus, Cambridge, UK
Psychology, Anglia Ruskin University - Cambridge Campus, Cambridge, UK.
BMJ Open. 2022 Jun 9;12(6):e054613. doi: 10.1136/bmjopen-2021-054613.
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.
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.
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.
ISRCTN11425138.
新的独立于痴呆症研究的干预措施（NIDUS-家庭）是一项由阿尔茨海默病学会资助的新的规范化、多模式心理社会干预措施，旨在支持患有痴呆症的人（PLWD）实现他们自己和他们的家庭照顾者设定的目标，以便他们能够更长时间地在家里独立、尽可能地生活。这个过程评估将嵌入在 NIDUS-家庭随机对照试验干预组（n=199）中，测试干预措施如何通过目标实现来影响变化。该评估将测试、完善和发展 NIDUS-家庭理论模型、相关因果假设和逻辑模型，以确定影响干预效果的关键机制和实施及背景因素。研究结果将为该项目的实际实施提供信息。
这个过程评估将是理论驱动的，并采用收敛性混合方法设计。根据目标实现量表（试验主要结果）的高低得分，对患者和家庭照顾者进行有针对性的抽样。在试验后，对患者和家庭照顾者进行（约 n=30）的定性访谈，并对他们各自的治疗师进行访谈，以探讨他们接受和提供干预措施的经验。访谈将进行迭代主题分析。同时，从 NIDUS-家庭的视频和/或音频记录中收集匹配的观察性定量数据。对所有干预组的患者进行接受度问卷调查，以收集更多的定量数据（n=199）。混合方法整合将使用交互式分析策略，通过混合方法矩阵考虑定性和定量发现，为个体层面的“案例研究”提供分析，并对“人群”层面的分析和解释进行联合展示。
该研究已获得卡姆登和国王十字研究伦理委员会（REC）的伦理批准。研究参考号：19/LO/1667。IRAS 项目 ID：271 363。这项工作是在 UCL 阿尔茨海默病学会卓越中心（300 号拨款）内进行的，用于在家中保持独立，是 NIDUS 计划的一部分。研究结果将通过出版物和会议传播，并作为实施研究和策略的建议。
ISRCTN11425138。
