跳至主要内容
临床试验/NCT05102812
NCT05102812已完成不适用

Feasibility of a Breakfast Group Intervention for Acute Stroke Units, to Provide Intensive Eating and Drinking Interventions as Well as Integrated Multi-disciplinary Team Working and Personalized Care

Sheffield Teaching Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2022年2月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
134
试验地点
2
主要终点
Proportion of patients who accept the breakfast group intervention

研究概览

简要总结

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.

详细描述

This study will develop a breakfast group intervention for acute stroke services, followed by an exploration of the feasibility and acceptability of this intervention in clinical practice. Feasibility studies are required to build the foundations for future research by exploring the practicalities of intervention delivery and the acceptability from a recipient perspective. The Medical Research Council (MRC) Framework definition for complex interventions has been used to guide study design as breakfast groups are considered to be complex, as they contain several complex interacting components and has a range of possible outcomes which are variable due to the nature of stroke impairments. Purposive or commonly known as selective sampling is an appropriate method for the study as there are only a limited number of primary data sources who can contribute to the study.

Number of sites involved:

  • Non-participant Observations Site - 1,2,3
  • Interview Sites - 3
  • Co-design Site - 1
  • Intervention delivery sites - 3
  • Focus groups sites - 2

Size of sample Non-participant Observations (Pre-intervention) Site 1 = 10 patients and 7 staff members Interviews Site 1 (pre-intervention) = 2 patients and 2 staff members = 4 Interviews Site 2 and 3 (post intervention) = 6-8 patient across both sites Co-design site 1 = 10 participants in the stakeholder group Intervention delivery and non-participant observations sites 1,2,3 = 15 across 3 sites Focus groups sites 2 and 3 = 6-8 staff members across 2 sites

Total patients= 35 Total Stakeholders = 10 Total Health care professionals = 17 Total participants = 62

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 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.

结局指标

主要结局

Proportion of patients who accept the breakfast group intervention

时间窗: 4 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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