Resumen
Background: Most people living with dementia want to remain living in their own homes and are supported to do so by family carers. No interventions have consistently demonstrated improvements to people with dementia’s life quality, functioning, or other indices of living as well as possible with dementia. We have co-produced, with health and social care professionals and family carers of people with dementia, a new intervention (NIDUS-family). To our knowledge, NIDUS-family is the first manualised intervention that can be tailored to personal goals of people living with dementia and their families and is delivered by facilitators without clinical training. The intervention utilizes components of behavioural management, carer support, psychoeducation, communication and coping skills training, enablement, and environmental adaptations, with modules selected to address dyads’ selected goals. We will evaluate the effect of NIDUS-family and usual care on goal attainment, as measured by Goal Attainment Scaling (GAS) rated by family carers, compared to usual care alone at 12-month follow-up. We will also determine whether NIDUS-family and usual care is more cost-effective than usual care alone over 12 months. Methods: A randomised, two-arm, single-masked, multi-site clinical trial involving 297 people living with dementia-family carer dyads. Dyads will be randomised 2:1 to receive the NIDUS-family intervention with usual care (n = 199) or usual care alone (n = 98). The intervention group will be offered, over 1 year, via 6–8 video call or telephone sessions (or face to face if COVID-19 restrictions allow in the recruitment period) in the initial 6 months, followed by telephone follow-ups every 1–2 months to support implementation, with a trained facilitator. Discussion: Increasing the time lived at home by people living with dementia is likely to benefit lives now and in the future. Our intervention, which we adapted to include remote delivery prior to trial commencement due to the COVID-19 pandemic, aims to address barriers to living as well and as independently as possible that distress people living with dementia, exacerbate family carer(s) stress, negatively affect relationships, lead to safety risks, and frequently precipitate avoidable moves to a care home. Trial registration: International Standard Randomised Controlled Trials Number ISRCTN11425138. Registered on 7 October 2019
| Idioma original | English |
|---|---|
| Número de artículo | 865 |
| Publicación | Trials |
| Volumen | 22 |
| N.º | 1 |
| DOI | |
| Estado | Published - dic. 2021 |
Nota bibliográfica
Funding Information:AB drafted the manuscript and managed study set up. PR and MP provided clinical supervision, developed and delivered training to the researchers, and provided input into intervention and study design. KL provided input into study and intervention design and lead study management at the University of Bradford. JB is managing the recruitment and study procedures and contributed to the writing of the manuscript. JBa and VV designed the statistical aspects and RH the health economic aspects of the study. LB and IL provided input into process evaluation and implementation strategy design. KR provided expertise on the primary outcome for the trial and designed and delivered researcher training on GAS. MO and DS delivered procedural and intervention training to the researchers and MO provided additional input into intervention design. GL, BD, HCK, JM, KW, JH, VO, and QS all provided input into study design. CC is the chief investigator of the study, led the study design intervention, and secured the funding for the study. All authors read and approved the final manuscript. This work is supported by Alzheimer’s Society (UK) and is being carried out within the UCL Alzheimer’s Society Centre of Excellence for Independence at home, NIDUS (New Interventions in Dementia Study) programme (Alzheimer’s Society Centre of Excellence grant AS-PR2-16-002.) The funder has not taken part in the design of the study, collection, analysis, and interpretation of data nor in writing the manuscript. The study funding has been reviewed by the UCL Joint Research Office and deemed sufficient to cover the requirements of the study. NHS costs will be supported via the Local Clinical Research Network.
Funding Information:
This work is supported by Alzheimer’s Society (UK) and is being carried out within the UCL Alzheimer’s Society Centre of Excellence for Independence at home, NIDUS (New Interventions in Dementia Study) programme (Alzheimer’s Society Centre of Excellence grant AS-PR2-16-002.) The funder has not taken part in the design of the study, collection, analysis, and interpretation of data nor in writing the manuscript. The study funding has been reviewed by the UCL Joint Research Office and deemed sufficient to cover the requirements of the study. NHS costs will be supported via the Local Clinical Research Network.
Publisher Copyright:
© 2021, The Author(s).
ASJC Scopus Subject Areas
- Medicine (miscellaneous)
- Pharmacology (medical)
PubMed: MeSH publication types
- Journal Article
- Randomized Controlled Trial