The Breaking "Bad Rest" Study: Interrupting Sedentary Time to Reverse Frailty Levels in Acute Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in the Frailty Index
研究概览
简要总结
This study will determine whether an intervention aimed at reducing sedentary time in patients admitted to acute care will result in decreased frailty levels at hospital discharge, compared to the current standard of care. All patients will be fitted with accelerometers then randomised to the control or intervention group. The control group will receive only standard of care while in hospital. Participants in the intervention group will engage in daily goal setting for time out-of-bed and have access to real-time feedback on a bedside monitor. Participants in the intervention group will also received assisted mobilization if they have not met their daily goal by the late afternoon. The main outcome is frailty, assessed by a frailty index.
详细描述
The objective of this study is to determine if an intervention designed to reduce sedentary time during a patient's stay in acute care will reduce patient's frailty levels more so than current standard of care. This study will be conducted at a single-centre, but will be a stratified, block randomised control trial. Fifty participants will be recruited within 24 hours of admission to a geriatric acute care unit. Both groups will be fitted with a device that measures sedentary and active time (accelerometer). Participants in the intervention group will have a daily goal for activity and will be provided with real-time feedback on attainment of that goal displayed on a bedside tablet. Participants in the intervention group who do not independently achieve their goal will be assisted in reducing their sedentary time in the afternoon and/or early evening to the maximum level of their ability; this level will be determined in consultation with the healthcare team. The primary outcome is a change in frailty during hospitalization, measured using a 30-item frailty index. The data collection phase is approximately 10 months. Data analysis will take an additional six months (16 months total). Knowledge-users will be involved during all stages of the project. The data generated from this study will enable us to scale up this intervention nationally and internationally. If the intervention is successful, it will warrant a study to implement the intervention as part of standard care. Ultimately, this study will inform guidelines to limit patients' sedentary behaviors in acute care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
A senior statistician will use a computer-generated random sequence to determine whether each patient is allocated to the control or intervention group. To minimize risk of bias, the RA who collects assessment data will remain blinded to the study group, with separate RAs assisting with the intervention. Only the statistician will hold the key to the control/intervention group.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anticipated hospital length of stay >1 day
- •Patient or care partner able to communicate in English
排除标准
- •Patient unable to provide informed consent and care partner not available to provide consent
- •Bedridden prior to hospital admission
- •Previous participation in our study (i.e. readmission during data collection phase)
- •End-of-life or waiting for long-term care facility
- •Patient is admitted to a shared room with a current study participant.
结局指标
主要结局
Change in the Frailty Index
时间窗: Change from baseline frailty up to a median 14 day hospital length of stay
The frailty index (FI) operationalizes frailty in clinical practice and for research. FI scores are calculated as the proportion of potential deficits present in a given individual. For this study we will construct a 30-item FI using a health questionnaire administered to patients or their care partners (if patients are not able to self-report) at each study time point. The proportion of patients changing their FI scores by \>=0.1 from baseline to hospital discharge is the primary outcome. Data collection is opportunistic, based on length of stay. The discharge date is not fixed - thus day-in-study at discharge will not be the same for all participants. Depending on length of stay, participants will provide data for additional time points between baseline and discharge, including week 1, week 2, week 3, week 4 and then in 30 day intervals. However, not every participant will have the same number of time points. Note that the median hospital length of stay is 14 days.
次要结局
- Change in upright time(Change from baseline upright time up to a median 14 day hospital length of stay)
- Change in upright bouts(Change from baseline upright bouts up to a median 14 day hospital length of stay)
- Change in mobility: Hierarchical Assessment of Balance and Mobility (HABAM)(Change from baseline mobility scores up to a median 14 day hospital length of stay)
- Falls(From baseline to 30 days after hospital discharge)
- Change in balance: Hierarchical Assessment of Balance and Mobility (HABAM)(Change from baseline balance scores up to a median 14 day hospital length of stay)
- Change in the Frailty Index(Change from baseline frailty up to a median 14 days hospital length of stay, and 30 days after hospital discharge)
- Hospital length of stay(From baseline up to a median 14 day hospital length of stay)
- In-hospital mortality(From baseline up to a median 14 day hospital length of stay)
- Hospital readmissions(From baseline up to 30 days after hospital discharge)
- Safety evaluation (frequency of adverse events)(From baseline up to a median 14 day hospital length of stay)
- Cost(From baseline up to 30 days after hospital discharge)
研究者
Olga Theou
PhD, Assistant Professor
Nova Scotia Health Authority