Clinical trial NCT05866094: nuTritiOn and deMentia AT hOme (TOMATO)
Official title: Feasibility Study of an Intervention to Provide Nutritional Care for People Living With Dementia at Home
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Undernutrition
Keywords: Dementia
Alzheimer's disease
Malnutrition
Undernutrition
Nutritional Care
Food
Eating
Drinking
Community
Home Care
Older adults
Ageing
Lead sponsor: Bournemouth University
Sponsor class: OTHER
Collaborators: name: Leeds Beckett University
name: University of Leeds
name: University of Exeter
name: Homecare Association
name: Leeds Comunity Healthcare NHS Trust
First posted: 2023-05-19
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants: People with dementia, their relatives, and home care workers
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility 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

Primary outcomes:
measure: Nutrition Intervention Refinement
timeFrame: Phase 1 - 4 Months
measure: Intervention Feasibility and Acceptability Testing
timeFrame: Phase 2 - 11 Months
Secondary outcomes:
measure: Nutritional status
timeFrame: Phase 2 - 11 Months
measure: Health-related quality of life
timeFrame: Phase 2 - 11 Months
measure: Functional status
timeFrame: Phase 2 - 11 Months
measure: Carer burden
timeFrame: Phase 2 - 11 Months
measure: Process Evaluation
timeFrame: 11 Months [Phase 2
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Participating Home Care Organisations
city: Warrington
country: United Kingdom
facility: Participating Home Care Organisation
Study officials:
affiliation: Bournemouth University
name: Jane Murphy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murphy J, Aryal N. Improving the provision of nutritional care for people living with dementia in care homes. Nurs Older People. 2020 Sep 22;32(5):23-29. doi: 10.7748/nop.2020.e1263. Epub 2020 Aug 12.
citation: Murphy JL, Aburrow A, Guestini A, Brown R, Parsons E, Wallis K. Identifying older people at risk of malnutrition and treatment in the community: prevalence and concurrent validation of the Patients Association Nutrition Checklist with 'MUST'. J Hum Nutr Diet. 2020 Feb;33(1):31-37. doi: 10.1111/jhn.12710. Epub 2019 Oct 22.
citation: Murphy JL, Holmes J, Brooks C. Nutrition and dementia care: developing an evidence-based model for nutritional care in nursing homes. BMC Geriatr. 2017 Feb 14;17(1):55. doi: 10.1186/s12877-017-0443-2.