NCT05102812

Brief Summary

Current evidence shows that many people living with stroke experience major problems with eating and drinking. We know that this can lead to malnutrition, dehydration, reduced muscle strength and depression. It can also lead to longer stays in hospital, reduced ability to participate in rehabilitation and in the long term poorer quality of life. People living with stroke say the pleasure gained from eating and drinking changes after a stroke. They describe feeling embarrassed and ashamed and report a loss of self-confidence. Therefore, being able to eat and drink independently is essential for health and well-being. People with stroke welcome opportunities to address eating and drinking problems early in their rehabilitation and would like more opportunities to practice the necessary skills needed, to regain independence. Early rehabilitation interventions have the potential to improve long-term outcomes by providing strategies, assistive devices and rehabilitation as early as possible in stroke recovery. Health care professionals are using breakfast groups to provide opportunities to practice preparation and consumption of food and drink with enabling support. Consultations with patients and health care professionals have found that the processes involved in breakfast group interventions lack rigour and multi-disciplinary team coordination, thus leading to uncertainty about what outcomes are achieved for each patient. This co-designed study aims to find out if it is possible to improve patient outcomes by providing more intensive interventions in a breakfast group format delivered by a range of health care professionals over five days of the week. The intervention will be co-designed with a stakeholder group comprising of patients, carers and stroke unit health care professionals supported by an advisory group, comprising of experts in the field. The intervention will be delivered in three sites and it will include a tool kit to support the integrated assessment, care plan and outcome measures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Feb 2022

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

First Submitted

Initial submission to the registry

October 20, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

February 17, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

12 months

First QC Date

October 20, 2021

Last Update Submit

August 11, 2023

Conditions

Keywords

Breakfast InterventionCo-design

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients who accept the breakfast group intervention

    4 weeks

Study Arms (1)

Breakfast Group Intervention

EXPERIMENTAL

The intervention will be piloted at Sheffield Teaching Hospitals for 1-2 weeks. Then will be refined and piloted at tow further stroke wards (Rotherham Hospitals NHS Foundation Trust and Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust)

Behavioral: Breakfast Group Intervention

Interventions

An actionable toolkit encompassing an assessment, a personalised care plan and a range of outcome measures.

Breakfast Group Intervention

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Language: Speaks English sufficient to participate in a group activity
  • Clinical Condition: Occurrence of a Stroke which has led to difficulties with performance of eating and drinking activities
  • Age range: Over 18 years of age
  • Cognition: Mild to moderate impairment (Mini-Mental State Examination MMsE\<15/30) able to consent or a consultee can support consent.
  • Location: Inpatient in an acute stroke ward/unit in the United Kingdom
  • Language: Speaks English sufficient to participate in a group activity
  • Age range: Over 18 years of age
  • Location: NHS Staff employed to work on an inpatient acute stroke ward/unit in the United Kingdom
  • Experience: Working in stroke rehabilitation

You may not qualify if:

  • No Stroke Diagnosis - Stroke Survivors only
  • Outside the stated age range
  • Outside the stated location
  • Cognitive impairment (Mini-Mental State Examination MMsE\<15/30 - Stroke Survivors only, or unable to consent with consultee support.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Pathway Assessment and Rehabilitation Centre

Sheffield, South Yorkshire, S2 3QE, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Natalie Jones

    Sheffield Teaching Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 2, 2021

Study Start

February 17, 2022

Primary Completion

February 8, 2023

Study Completion

February 8, 2023

Last Updated

August 15, 2023

Record last verified: 2023-08

Locations