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临床试验/NCT05384730
NCT05384730已完成不适用

A Feasibility and Acceptability Study of a Virtual Multimodal Intervention Delivered by Volunteers to Improve Functional Outcomes of Frail Older Adults Discharged From Hospital

University Hospital Southampton NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年10月28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
32
试验地点
2
主要终点
Volunteers Trained

研究概览

简要总结

Frail2Fit will explore the feasibility of training volunteers to deliver online nutrition, exercise, and behaviour change (supported self-management) to improve the health of older people after discharge from hospital. The study also aims to explore if the supported self-management is acceptable to older people, their family members and/or carers, and the volunteers.

Between 30-60% of older people in hospital lose muscle strength and function (deconditioning) and around 14% of older adults in hospital are frail. Reduced muscle function and frailty increase risk of poor health outcomes, including reduced quality of life, increased risk of hospital readmission and increased risk of mortality. Therefore, intervening to prevent functional decline is a high-priority patient-centred outcome. Current evidence suggest that physical activity (PA) and nutrition interventions are key to maintaining independence and improving frailty status. In response to the COVID-19 restrictions, healthcare and rehabilitation have increasingly turned to virtual modes of delivery, such as telehealth methods. The increasing use of technology in the daily lives of many allows PA and nutrition interventions to be delivered online. For instance, the investigators have developed and evaluated a programme using online clinics to successfully support over 600 cancer patients living at home to stay active and eat well with provision of emotional support (SafeFit study). With many older people now using the internet for social connection, the team have an opportunity to investigate whether a similar model can improve the health of older people.

This study aims to explore the feasibility and acceptability of implementing volunteer-led online exercise and nutrition support to frail older people discharged from hospital. The investigators aim to develop and evaluate a training programme for volunteers, determine the acceptability of the intervention through qualitative methods and identify facilitators and barriers to its implementation. The investigators will also explore the impact of the intervention on health outcomes for older people to inform future trial.

详细描述

Study design A quasi-experimental mixed methods approach will be used to determine the feasibility and acceptability of implementing a volunteer-led multi-modal intervention for discharged older adults with frailty. This feasibility study will be conducted at the University Hospital Southampton NHS Foundation Trust (UHS), training hospital volunteers to deliver virtual group support for older adults discharged from UHS. The acceptability of the intervention will also be examined through qualitative interviews to explore the views and experiences of volunteers, trainers, carers and older adults involved in this study. The impact of the intervention on physical activity levels and functional outcomes will be measured.

Participants Older adults aged 65 years or above with frailty (clinical frailty score ≥5) who have been discharged from UHS will be invited to participate in this study. Participants must be able to walk at least a few steps upon hospital discharge and be cleared by their clinician as safe to exercise. Patients will be identified and approached by their clinical care team, if they are interested in participating in the research a member of the research team will obtain written informed consent. A sample size of 30 participants was chosen in line with previous sample size recommendations for feasibility studies of 24-50 participants. This sample size was considered an appropriate number that is pragmatic and achievable within the study timescale and resources available.

Recruitment and training of volunteers Volunteers from the UHS patient support hub will be invited to participate in the study and receive training to deliver the intervention. Volunteers aged 16 years or above who have completed the generic volunteer clearance and training at the hospital and who are safe to exercise will be identified by hospital voluntary services. Interested volunteers will be approached by a member of the research team to complete written informed consent. A sample size of 6 volunteers was chosen to provide sufficient cover to deliver the Frail2Fit intervention to small groups of older adults with 2 volunteers supporting each group.

The volunteer training programme will consist of a bespoke training package adapted from the SafeFit training guidance, supported, and delivered by an expert dietician (Prof Jane Murphy), psychologist (Judit Varkonyi-Sepp), and clinical exercise instructor, Dr Samantha Meredith (SM), and led by the PI, Dr Stephen Lim (SL). Training will be conducted at UHS for 2 days and 1 day of online training. The training sessions will include training on personal safety and safety of participants, and the exercise, nutrition and behaviour change protocols. As these are existing volunteers, they would have been recruited, and received the generic clearance and training provided by UHS. Throughout the study period, fidelity checks will be conducted by SM and SL to ensure that the volunteers are delivering high quality exercise sessions. Volunteers will also receive training on how to document adverse events that occur during the classes.

Intervention The intervention duration will be 3 months. Participants will receive three group sessions per week for 1 month (weeks 1-4), twice per week for the second month (weeks 5-8), and once weekly for the last month (weeks 9-12), with a maximum of 24 sessions. The tapered nature of the intervention was chosen to provide suitable support for older adults post-discharge with the aim to gradually encourage increased self-management to foster independence post-intervention. Components of the intervention, including exercise, nutrition support and behaviour change support, will be delivered from an online platform (Zoom). Each group session will last 40-60 minutes, including 20-30 minutes of exercise followed by 20-30 minutes of nutrition support. The components of the intervention and the training package have been adapted from the SafeFit trial and will be delivered in line with behaviour change principles to maximise participant uptake, adherence and lifestyle self-management.

研究设计

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

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Older adults age 65 years and above
  • Able to provide written consent
  • Discharged from UHS
  • Identified as frail (Clinical Frailty Scale ≥5)
  • Able to walk at least a few steps upon hospital discharge
  • Able to communicate fluently enough in English
  • Volunteers:
  • Established volunteers at UHS patient support hub
  • Age 16 years and above
  • Completed the generic volunteer clearance and training at UHS
  • Able to provide written informed consent
  • Able to communicate fluently enough in English

排除标准

  • Older adults who are not able to safely complete the exercises included in the intervention
  • Patients who are discharged to rehabilitation units, or care homes
  • Patients receiving end of life care
  • Volunteers:
  • Volunteers who are unable to safely complete the exercises included in the intervention will be excluded from the study

结局指标

主要结局

Volunteers Trained

时间窗: 6 months

The number of volunteers recruited to the study and trained.

Volunteer Retention

时间窗: 6 months

The number of volunteers retained at the end of the study

Adherence - Online

时间窗: post-intervention = 3-months

The percentage of online sessions completed

Adherence - Telephone Support

时间窗: post-intervention= 3-months

The percentage of telephone sessions completed

次要结局

  • Functional Ability(Baseline, post-intervention (3-months) and follow-up (6-months))
  • Device-based Physical Activity Levels(Baseline, post-intervention (3-months) and follow-up (6-months))
  • Appetite(Baseline, Post-intervention (3-month) and follow-up (6-month))
  • Depression and Anxiety(Baseline, post-intervention (3-month) and follow-up (6-month))
  • Well-being(Baseline, Post-intervention (3-month) and follow-up (6-month))
  • Patient's Subjective Assessment of Quality of Life(Baseline, Post-intervention (3-month) and follow-up (6-month))
  • Self-efficacy for Managing Chronic Disease(Baseline, Post-intervention (3-month) and follow-up (6-month))
  • Self-reported Physical Activity(Baseline, Post-Intervention (3-month), Follow-Up (6-months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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