NCT03835455

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 8, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

7 months

First QC Date

January 25, 2019

Last Update Submit

July 24, 2021

Conditions

Stroke, Acute

Keywords

Finger food

Outcome Measures

Primary Outcomes (3)

  • Eligibility rate

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

    6 months

  • Recruitment rate

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

    6 months

  • Attrition rate

    Number of participants without fully completed outcome measures

    6 months

Secondary Outcomes (3)

  • Dietary intake of participants over 3 mealtimes

    3 mealtimes

  • Costs of implementing a finger food menu

    6 months

  • Fidelity of intervention

    6 months

Other Outcomes (2)

  • Patient experience

    6 months

  • Staff experience

    6 months

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

On stroke rehabilitation ward

You may qualify if:

  • Current patient on stroke rehabilitation ward
  • years or older
  • Normal textured food

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Southampton NHS trust

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Milly Heelan

    University of Southampton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2019

First Posted

February 8, 2019

Study Start

January 21, 2019

Primary Completion

September 1, 2019

Study Completion

December 1, 2019

Last Updated

July 27, 2021

Record last verified: 2021-07

Locations

GB(1)