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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03835455
Other study ID # 40715
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 21, 2019
Est. completion date December 1, 2019

Study information

Verified date July 2021
Source University of Southampton
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date December 1, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom University Hospital Southampton NHS trust Southampton

Sponsors (1)

Lead Sponsor Collaborator
University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Patient experience Semi-structured interviews with participants to determine patient experience 6 months
Other Staff experience Semi-structured interviews with staff to determine facilitators and barriers to using the menu on the ward 6 months
Primary Eligibility rate Number of patients eligible for study based on inclusion and exclusion criteria 6 months
Primary Recruitment rate Number of patients approached vs number of patients recruited to the study 6 months
Primary Attrition rate Number of participants without fully completed outcome measures 6 months
Secondary Dietary intake of participants over 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. 3 mealtimes
Secondary Costs of implementing a finger food menu A cost consequence analysis will be used to describe direct and indirect costs associated with providing a finger food menu. 6 months
Secondary Fidelity of intervention Fidelity determined through observation field notes 6 months
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