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临床试验/NCT05866094
NCT05866094已完成不适用

Feasibility Study of an Intervention to Provide Nutritional Care for People Living With Dementia at Home

Bournemouth University5 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2023年4月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
139
试验地点
5
主要终点
Nutrition Intervention Refinement

研究概览

简要总结

The purpose of this study is to refine, implement and assess the acceptability and feasibility of an existing nutrition intervention applied to people living with dementia receiving home care.

详细描述

In the United Kingdom, two-thirds of people with dementia live at home and rely on family and friends to support with eating and drinking. Making sure people eat and drink well when they have dementia can be difficult as dementia progresses. Many with dementia are therefore at risk of being undernourished. This can be caused by poor appetite as well as eating and swallowing problems. Being undernourished can lead to poorer health and quality of life for people with dementia (and their carers), increased hospital admissions and health care use costing around £23.5 billion in terms of health and social care expenditure.

Home care workers provide care for people with dementia more frequently and for longer than healthcare professionals. Existing research and our engagement work indicate home care workers are well positioned to assess nutritional status and intervene early, but currently lack training, access to resources and support from NHS services. A more pro-active and wide-ranging approach to nutritional assessment and management is needed targeting interventions at home care workers and family carer dyads, with input from appropriate healthcare professionals.

As a collaborative project, the TOMATO study aims to work together with home care workers, people with dementia, and family carers to adapt a nutrition intervention (initially developed for care home) to support people living with dementia at home with eating and drinking. The intervention includes training programme, toolkit with video, workbook and guides for staff and family carers, and resources and leaflets.

This study will take place in Dorset, Midlands and West Yorkshire in two phases.

Phase 1: The first phase involves adapting the existing nutrition intervention by getting feedback from people with dementia, family carers, home care staff and nutrition experts through semi-structured interviews.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants: People with dementia, their relatives, and home care workers
  • Inclusion Criteria:
  • People with Dementia
  • formal diagnosis or functional symptoms associated with probable dementia (assessed by a senior home care worker using the FAST).
  • have family member/friend providing care/support and resident in the same house as the person with dementia or living close by.
  • be currently or have recently (in last 6-months) been at risk of/experienced malnutrition in receipt of home care services.
  • - For interviews, people with dementia will
  • be able to communicate fluently enough in English or provide informed consent with the assistance of a translator or family member to participate.
  • be able to recall their experiences of malnutrition and carer/home care worker responses well enough to discuss.
  • Carers and Home Care Workers
  • currently or have recently (in last 6-months) provided care for someone with dementia at risk of/experiencing malnutrition.
  • able to communicate fluently enough in English or provide informed consent with the assistance of a translator or family member to participate.

排除标准

  • People with Dementia
  • Who are at end of life or on an end-of-life care pathway.
  • Permanently cared for in bed.
  • Do not have an informal caregiver.
  • having specialist nutritional support e.g., feeding via tube.
  • Carers and Home Care Workers
  • have not recently (in last 6-months) provided care for someone with dementia at risk of/experiencing malnutrition.
  • not able to communicate fluently enough in English or provide informed consent

研究组 & 干预措施

Nutrition Intervention

Experimental

Intervention Feasibility Testing (11-months, Phase 2)

干预措施: Nutritional Intervention (Behavioral)

结局指标

主要结局

Nutrition Intervention Refinement

时间窗: Phase 1 - 4 Months

Exploring the perspective of participants in phase 1 via semi-structured in-depth interviews (people with dementia, their family carers, and home care staff). • Qualitative analysis will be carried out to understand more about how nutritional care is currently provided for people with dementia at home and how our existing nutrition intervention can be adapted for home care.

Intervention Feasibility and Acceptability Testing

时间窗: Phase 2 - 11 Months

1. Recruitment: Percentage of participants recruited from participating home care provider. 2. Attrition rate: Percentage of participants who drop out of the study before completion. 3. Qualitative analysis of the feasibility and acceptability of the adapted intervention from the perspective of people with dementia, their family carers, and home care staff and healthcare professionals.

次要结局

  • Nutritional status(Phase 2 - 11 Months)
  • Health-related quality of life(Phase 2 - 11 Months)
  • Functional status(Phase 2 - 11 Months)
  • Carer burden(Phase 2 - 11 Months)
  • Process Evaluation(11 Months [Phase 2)
  • Nutritional status(Phase 2 - 11 Months)
  • Health-related quality of life(Phase 2 - 11 Months)
  • Functional status(Phase 2 - 11 Months)
  • Carer burden(Phase 2 - 11 Months)
  • Process Evaluation(11 Months [Phase 2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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