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NCT Number: NCT03835455

Acceptability and Feasibility of Finger Foods

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.

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Southampton NHS trust

Southampton, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Eligibility rate

    Time frame: 6 months

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

  2. Recruitment rate

    Time frame: 6 months

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

  3. Attrition rate

    Time frame: 6 months

    Number of participants without fully completed outcome measures

Secondary outcomes

  1. Dietary intake of participants over 3 mealtimes

    Time frame: 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

    Time frame: 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

    Time frame: 6 months

    Fidelity determined through observation field notes

Other outcomes

  1. Patient experience

    Time frame: 6 months

    Semi-structured interviews with participants to determine patient experience

  2. Staff experience

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

University of Southampton

Other

Registry information

Official study title

A Mixed Methods Study to Determine the Acceptability and Feasibility of Providing Finger Foods as Nutritional Support for Patients After Stroke in Hospital

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 8, 2019
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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