Clincosm LogoSign in Get a demo

Acceptability and Feasibility of Finger Foods

Sponsor
University of Southampton (Other)
Overall Status
Completed
CT.gov ID
NCT03835455
Collaborator
(none)
31
Enrollment
1
Location
10.3
Actual Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will investigate the feasibility of using a finger food menu on an acute stroke rehabilitation ward. This study has a mixed methods design, with quantitative, qualitative and economic components which will be used to inform a future randomised control trial.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    31 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    A Mixed Methods Study to Determine the Acceptability and Feasibility of Providing Finger Foods as Nutritional Support for Patients After Stroke in Hospital
    Actual Study Start Date :
    Jan 21, 2019
    Actual Primary Completion Date :
    Sep 1, 2019
    Actual Study Completion Date :
    Dec 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Eligibility rate [6 months]

      Number of patients eligible for study based on inclusion and exclusion criteria

    2. Recruitment rate [6 months]

      Number of patients approached vs number of patients recruited to the study

    3. Attrition rate [6 months]

      Number of participants without fully completed outcome measures

    Secondary Outcome Measures

    1. Dietary intake of participants over 3 mealtimes [3 mealtimes]

      Estimation of dietary intake over 3 mealtimes. This will include a standard mealtime and 2 meals when the finger menu is offered. This will be measured as energy and protein intake.

    2. Costs of implementing a finger food menu [6 months]

      A cost consequence analysis will be used to describe direct and indirect costs associated with providing a finger food menu.

    3. Fidelity of intervention [6 months]

      Fidelity determined through observation field notes

    Other Outcome Measures

    1. Patient experience [6 months]

      Semi-structured interviews with participants to determine patient experience

    2. Staff experience [6 months]

      Semi-structured interviews with staff to determine facilitators and barriers to using the menu on the ward

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Current patient on stroke rehabilitation ward

    • 65 years or older

    • Normal textured food

    Exclusion Criteria:

    • On the end of life pathway

    • Partial or full enteral feeding

    • Significant food allergies, intolerances or other dietary restrictions that could not be catered for by the finger food menu.

    • Unable to give consent or no consultee able to consent on behalf of patient

    • In a side room on the ward

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Southampton NHS trust Southampton United Kingdom

    Sponsors and Collaborators

    • University of Southampton

    Investigators

    • Principal Investigator: Milly Heelan, University of Southampton

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Southampton
    ClinicalTrials.gov Identifier:
    NCT03835455
    Other Study ID Numbers:
    • 40715
    First Posted:
    Feb 8, 2019
    Last Update Posted:
    Jul 27, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Southampton
    Finger food
    Additional relevant MeSH terms:
    Stroke

    Study Results

    No Results Posted as of Jul 27, 2021