- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03835455
Acceptability and Feasibility of Finger Foods
July 24, 2021 updated by: University of Southampton
A Mixed Methods Study to Determine the Acceptability and Feasibility of Providing Finger Foods as Nutritional Support for Patients After Stroke in Hospital
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
31
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
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Southampton, United Kingdom
- University Hospital Southampton NHS Trust
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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
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
On stroke rehabilitation ward
Description
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
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eligibility rate
Time Frame: 6 months
|
Number of patients eligible for study based on inclusion and exclusion criteria
|
6 months
|
Recruitment rate
Time Frame: 6 months
|
Number of patients approached vs number of patients recruited to the study
|
6 months
|
Attrition rate
Time Frame: 6 months
|
Number of participants without fully completed outcome measures
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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3 mealtimes
|
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.
|
6 months
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Fidelity of intervention
Time Frame: 6 months
|
Fidelity determined through observation field notes
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6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient experience
Time Frame: 6 months
|
Semi-structured interviews with participants to determine patient experience
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6 months
|
Staff experience
Time Frame: 6 months
|
Semi-structured interviews with staff to determine facilitators and barriers to using the menu on the ward
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Milly Heelan, University of Southampton
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)
January 21, 2019
Primary Completion (Actual)
September 1, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
January 25, 2019
First Submitted That Met QC Criteria
February 7, 2019
First Posted (Actual)
February 8, 2019
Study Record Updates
Last Update Posted (Actual)
July 27, 2021
Last Update Submitted That Met QC Criteria
July 24, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 40715
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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