nuTritiOn and deMentia AT hOme (TOMATO) (TOMATO)

September 16, 2025 updated by: Bournemouth University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

139

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Greater London, United Kingdom
        • Participating Home Care Organisation
      • North West Regions, United Kingdom
        • Participating Home Care Organisation
      • South West, United Kingdom
        • Participating Home Care Organisations
      • West Midlands, United Kingdom
        • Participating Home Care Organisation
      • Yorkshire, United Kingdom
        • Participating Home Care Organisation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutrition Intervention
Intervention Feasibility Testing (11-months, Phase 2)
Behavioral: Nutritional Intervention

Nutrition training will be provided to home care staff to deliver the intervention via the participating Home Care Providers from two localities (South and North of England).

This phase will involve identification of people with dementia on their caseload, preliminary assessment of potential impact via collection of quantitative data at baseline (pre-intervention), and at 4 months follow-up (4 months after the first visit by trained home care workers, following baseline).

A process evaluation will be conducted to gather data on intervention fidelity and implementation (quantitative and qualitative).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutrition Intervention Refinement
Time Frame: 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.
Phase 1 - 4 Months
Intervention Feasibility and Acceptability Testing
Time Frame: 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.
Phase 2 - 11 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional status
Time Frame: Phase 2 - 11 Months

Preliminary assessment at baseline and 4 months follow up:

a. Nutritional status

- Body Mass Index (BMI): Body weight (kg) and height (m2) will be combined to determine BMI (weight (kg) / height (m2)).

BMI of < 20 kg/m2 will be an indicator of undernutrition.
Phase 2 - 11 Months
Health-related quality of life
Time Frame: Phase 2 - 11 Months

Preliminary assessment at baseline and 4 months follow up:

b. Health-related quality of life for people with dementia and carers will be measured using

  • EuroQol 5-Dimension 5-Level (EQ-5D-5L) with a scale from 0 to 100; higher scores indicate better quality of life.
  • Dementia Quality of Life questionnaire (DEMQoL) and DEMQoL-Proxy; 4-point scale, higher scores indicate better quality of life.
Phase 2 - 11 Months
Functional status
Time Frame: Phase 2 - 11 Months

Preliminary assessment at baseline and 4 months follow up:

c. Functional status

  • Functional status (Deterioration in Daily Living Activities in Dementia) using Modified Barthel Index measures; 2-point scale rating with 0 to 20 points. Higher score indicates greater independence.
  • Functioning status using Lawton-Brody Instrumental Activities of Daily Living Scale; 4-point scale. Higher scores indicate greater independence and better functional ability.
Phase 2 - 11 Months
Carer burden
Time Frame: Phase 2 - 11 Months
d. Carer burden using Zarit Burden Interview; 0 to 88 points; higher scores indicate severe burden.
Phase 2 - 11 Months
Process Evaluation
Time Frame: 11 Months [Phase 2

Process Evaluation at 4 months: a process evaluation to gather data on intervention fidelity and implementation.

  1. Semi-structured interviews conducted individually, in pairs or small groups with participant dyads (family carers will be given the option to have a separate interview), home care workers and managers from the participating regions.
  2. Associated costs variables to deliver the intervention.
11 Months [Phase 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bournemouth University

Collaborators

University of Leeds
University of Exeter
Leeds Comunity Healthcare NHS Trust
Leeds Beckett University
Homecare Association

Investigators

  • Principal Investigator: Jane Murphy, PhD, Bournemouth University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

May 18, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2223/TOMATO/ IRAS1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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