Stroke, AcuteNCT03835455
Acceptability and Feasibility of Finger Foods
An observational study of Stroke, Acute, run by University of Southampton at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Stroke, Acute
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jan 2019to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: On stroke rehabilitation ward
Who may be able to join
- Current patient on stroke rehabilitation ward
- 65 years or older
- Normal textured food
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Southampton NHS trust
Southampton
About this study
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
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.
- Conditions
- Stroke, Acute
- Keywords
- Finger food
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility rate
Number of patients eligible for study based on inclusion and exclusion criteria
Measured: 6 months
Recruitment rate
Number of patients approached vs number of patients recruited to the study
Measured: 6 months
Attrition rate
Number of participants without fully completed outcome measures
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 3 mealtimes
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.
Measured: 6 months
Fidelity of intervention
Fidelity determined through observation field notes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start21 Jan 2019
- Primary completion1 Sep 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milly Heelan, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835455
- Sponsor's protocol ID
- 40715
- Status last verified
- Jul 2021
- First submitted
- 25 Jan 2019
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03835455
- Acronym / sponsor ID
- 40715
- Conditions
- Stroke, Acute
- Keywords
- Finger food
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- On stroke rehabilitation ward
Key inclusion criteria (3 listed)
- Current patient on stroke rehabilitation ward
- 65 years or older
- Normal textured food
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Eligibility rate
Time frame: 6 months
Number of patients eligible for study based on inclusion and exclusion criteria
Recruitment rate
Time frame: 6 months
Number of patients approached vs number of patients recruited to the study
Attrition rate
Time frame: 6 months
Number of participants without fully completed outcome measures
3 secondary outcomes
Dietary intake of participants over 3 mealtimes
Time frame: 3 mealtimes
Costs of implementing a finger food menu
Time frame: 6 months
Fidelity of intervention
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
Related trials for Stroke, Acute
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milly Heelan principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility rate (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.