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NCT05866094 | RECRUITING | Dementia


nuTritiOn and deMentia AT hOme (TOMATO)
Sponsor:

Bournemouth University

Brief Summary:

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.

Condition or disease

Dementia

Undernutrition

Intervention/treatment

Nutritional Intervention

Phase

NA

Detailed Description:

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. Phase 2: The second phase involves training home care workers to deliver the adapted approach to people with dementia and family carers (up to 32 participant dyads) in receipt of care at home. Information about food intake, weight, practicality, and costs of the approach will be gathered. Semi-structured interviews will also be conducted with participants living with dementia, their family carers, and home care managers to get their feedback on the approach. If feasible and acceptable (based on progression criteria), findings will inform the design of future trial (effectiveness/implementation research). The TOMATO patient and public involvement group which consist of family carers, people with dementia and home care workers will provide input throughout the study duration (including project design, delivery, analysis, reporting and dissemination of the findings).

Study Type : INTERVENTIONAL
Estimated Enrollment : 162 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Feasibility Study of an Intervention to Provide Nutritional Care for People Living With Dementia at Home
Actual Study Start Date : 2023-04-12
Estimated Primary Completion Date : 2024-12-31
Estimated Study Completion Date : 2024-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
    Exclusion Criteria
    • 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

  • nuTritiOn and deMentia AT hOme (TOMATO)

    Location Details

    NCT05866094


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    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations


    RECRUITING

    United Kingdom,

    Participating Home Care Organisations

    Bournemouth, United Kingdom,

    RECRUITING

    United Kingdom,

    Participating Home Care Organisation

    Warrington, United Kingdom,

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