PIVOT Trial: Promoting Increased Physical Activity in Hospitalised Older Adults With Trained Volunteers: An Implementation Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 4
- 主要终点
- Qualitative interview data exploring the acceptability of the intervention, including barriers and enablers to the implementation of the intervention.
研究概览
简要总结
The PIVOT study will explore the feasibility of training volunteers to deliver exercise to hospitalised older adults to improve the health of older people and prevent deconditioning while in hospital. Loss of strength and mobility (i.e., deconditioning) is common in hospitalised older people and is associated with a decline in physical function, poorer quality of life and increased health and care costs. Physical inactivity is an important and modifiable risk factor. A previous study showed it is feasible to train volunteers to engage with older people in hospital and facilitate walking and bedside exercises. The intervention was well-received by older adults, staff members and volunteers. The aim of this study is to determine the feasibility of implementing volunteer-led physical activity in three hospitals of varying sizes in different regions.
Older adults aged 65 years and above admitted to an acute hospital will be invited to participate in the study. The study aims to recruit 180 participants; 90 from three intervention sites and 90 from a control site. Participants at the intervention sites will receive a twice daily volunteer-led physical activity intervention, and participants at the control site will receive usual care.
Participants who are able to mobilise independently will perform walking exercises and individuals with mobility impairments will perform bedside exercises. The volunteers will be trained and monitored by hospital therapists. The acceptability of the intervention will be explored through interviews with patients, volunteers, and staff. Intervention feasibility will also be examined through measuring retention of trainers, volunteers, and patients on the intervention, and adherence to the exercise.
Study findings will help to determine the feasibility of the volunteer-led physical activity intervention across different sized hospitals, voluntary service teams, and therapy services to explore the implementation and roll out of the intervention across NHS sites and the development of a toolkit to support knowledge transfer.
详细描述
Aim The aim of the current research is to explore whether volunteers can be trained to deliver exercise support to older adults across three different sized hospitals in different locations. Researchers will also explore if the intervention is accepted by patients, volunteers and staff and if it has any benefits on patients' health and functional outcomes (e.g., quality of life and muscle strength).
Study Design This is a multicentre feasibility study using mixed methods (i.e., quantitative and qualitative measures) to explore the implementation of a volunteer-led physical activity intervention to older adults in hospital. The study will include three intervention sites and one control site. Feasibility studies are used to determine whether an intervention is appropriate for further evaluation, to determine sample sizes for controlled trials and to assess whether the ideas and findings can be shaped to be relevant and sustainable.
Sample Size A sample size of 180 patients, 90 intervention (30 from each intervention site) and 90 from the control site, 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 at each site.
This research aims to recruit 15 volunteers at each site to provide sufficient cover to deliver the intervention. In a previous study (SoMoVe trial) 17 volunteers were recruited, 16 completed training and 12 were retained.
Recruitment and Consent Older adults with an acute medical admission to four hospitals will be screened for eligibility by research nurses. Eligible patients will be introduced to the study by ward staff. Those who are interested in the study will be approached by the research team for further information and information sheets will be provided. Written informed consent will be obtained from all patients who agree to participate in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Adults aged 65 years and above
- •Able to provide written informed consent
- •Adults aged 18 years and above
- •Completed the generic clearance and training with the hospital voluntary services
- •Able to provide written informed consent
- •Able to communicate fluently enough in English. Fluent English is required to ensure the intervention content can be delivered clearly and thus safely to participants.
排除标准
- •Anyone with a severe cognitive impairment (MoCA less than 10)
- •Patients isolated for infection control reasons
- •Patients receiving end of life care
- •Volunteers that are unable to safely complete the exercises included in the intervention will be excluded from the study.
研究组 & 干预措施
Control
Usual care
Volunteer-led physical activity
Trained volunteers will deliver walking, or bedside exercises with hospitalised older adults twice per day.
干预措施: Volunteer-led physical activity (Behavioral)
结局指标
主要结局
Qualitative interview data exploring the acceptability of the intervention, including barriers and enablers to the implementation of the intervention.
时间窗: through intervention completion, an average of 2 months
Qualitative interviews will be conducted with service managers, therapy managers, patients, nurses, ward therapists, and volunteers from all study sites, to determine the acceptability of the intervention.
The number of volunteers recruited to the study (%).
时间窗: through study completion, an average of 3 years
Feasibility of recruiting volunteers to deliver the physical activity intervention at each hospital site
Number of trainers trained in each hospital site (%)
时间窗: through study completion, an average of 3 years
Feasibility of recruiting therapists to deliver the intervention at each hospital site.
Adherence to the intervention (%)
时间窗: through study completion, an average of 3 years
The number of participants retained in the intervention at each hospital site.
Recruitment rate (%) of participants in each site
时间窗: through study completion, an average of 3 years
Feasibility of recruiting older adults onto the volunteer-led physical activity intervention at each hospital site.
The number of volunteers trained at the end of the study period (%)
时间窗: through study completion, an average of 3 years
Feasibility of training volunteers to deliver the physical activity intervention at each hospital site
The number of volunteers retained at the end of the study period (%)
时间窗: through study completion, an average of 3 years
Feasibility of retaining volunteers to deliver the physical activity intervention at each hospital site
Number of trainers retained in each hospital site (%)
时间窗: through study completion, an average of 3 years
Feasibility of retaining therapists to deliver the intervention at each hospital site.
次要结局
- Patient's subjective assessment of quality of life - visual analogue scale (VAS)(Baseline and post intervention, an average of 2 months)
- Grip strength(Baseline and post intervention, an average of 2 months)
- Short Physical Performance Battery (SPPB)(Baseline and post intervention, an average of 2 months)
- Patient's subjective assessment of quality of life - EuroQol (EQ-5D-5L)(Baseline and post intervention, an average of 2 months)
- Physical activity(7 days upon recruitment)