Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT05866094
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2023-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
nuTritiOn and deMentia AT hOme (TOMATO)
Sponsor:
Bournemouth University
Organization:
Study Overview
Official Title:
Feasibility Study of an Intervention to Provide Nutritional Care for People Living With Dementia at Home
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOMATO
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).
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: