Stroke, Acute Clinical Trial
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
| 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 |
| Verified date | July 2021 |
| Source | University of Southampton |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University Hospital Southampton NHS trust | Southampton |
| Lead Sponsor | Collaborator |
|---|---|
| University of Southampton |
United Kingdom,
| 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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