The Breaking Bad Rest Study: Interrupting Sedentary Time to Reverse Frailty Levels in Acute Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Breaking Bad Rest Study: Interrupting Sedentary Time to Reverse Frailty Levels in Acute Care

Conditions
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Sedentary Lifestyle

Intervention / Treatment
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* Behavioral: Sedentary behavior reduction intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anticipated hospital length of stay >1 day Patient or care partner able to communicate in English Exclusion Criteria: 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be classified into three strata based on their baseline mobility measured with the HABAM. Within each strata, patients will be randomly allocated to the control (n=25) and intervention (n=25) groups in temporal blocks. In the event of Covid-19 related interruptions to the study, temporal blocks aim to keep the number of participants in the intervention and control groups similar at all times. This stratified, block randomised control trial design will ensure a similar distribution of patient characteristics in the control and intervention groups and will safeguard against possible interruptions due to Covid-19.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Fitted with an accelerometer to measure time spent out of bed while in hospital. Otherwise, participants in the control group will receive usual care from the hospital medical team during their hospital stay. Daily activities of participants will not be restricted if patients are assigned to the control group. | |
| Experimental: Intervention Group<br>Fitted with accelerometer to measure time spent out of bed while in hospital; daily goals set for time spent out of bed; mobilization feedback real-time feedback on goal attainment; hands on mobilization by physiotherapist for participants in late afternoon for participants who do not meet daily goal. | Behavioral: Sedentary behavior reduction intervention<br>* Participants will be provided with a device to measure physical activity and sedentary behaviours. A tablet will be in the research office and each afternoon, it will be synced to the device to assess the activity progress of the patient. The research team will deliver an upright time goal and will target a 20% increase in upright time from the previous hospital day. Physiotherapist research assistants will visit the participants every afternoon to monitor progress and safely mobilize participants to their maximum ability if they have not met their daily goal (including weekend). The maximum level of ability will be determined in consultation with the healthcare team. Participants who do not meet their goal will be mobilized in the late afternoon/ early evening.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Frailty Index | 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. | Change from baseline frailty up to a median 14 day hospital length of stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Frailty Index | 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. Secondary outcome for the FI is a change from baseline up to one month following hospital discharge as a continuous measure. 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. | Change from baseline frailty up to a median 14 days hospital length of stay, and 30 days after hospital discharge | 
| Change in upright time | Time (minutes/day) spent upright out of bed (upright time) will be tracked continuously during the participants' hospital length of stay using accelerometers for both groups. Patients will be fitted with accelerometers within 24 hours of admission. An ActivatorTM (PAL Technologies Ltd) accelerometer will be attached to the mid-thigh of the patients' dominant side. 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. | Change from baseline upright time up to a median 14 day hospital length of stay | 
| Change in upright bouts | The number of times/day that a participants gets upright out of bed (upright bouts) will be tracked continuously during the participants' hospital length of stay using accelerometers for both groups. Patients will be fitted with accelerometers within 24 hours of admission. An ActivatorTM (PAL Technologies Ltd) accelerometer will be attached to the mid-thigh of the patients' dominant side. 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. | 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) | The HABAM is a clinical tool used to obtain a global measure of a patients' health through the assessment of mobility, transfers and balance. Patients receive daily scores based on demonstrated ability in each focal area; testing if the patient can move around in bed, sit up in bed, stand up, etc. The median hospital length of stay is expected to be 14 days, but many patients will have a longer length of stay. This means that some patients will have more data collection time points than others. | Change from baseline mobility scores up to a median 14 day hospital length of stay | 
| Change in balance: Hierarchical Assessment of Balance and Mobility (HABAM) | The HABAM is a clinical tool used to obtain a global measure of a patients' health through the assessment of mobility, transfers and balance. Patients receive daily scores based on demonstrated ability in each focal area; testing if the patient can move around in bed, sit up in bed, stand up, etc. The median hospital length of stay is expected to be 14 days, but many patients will have a longer length of stay. This means that some patients will have more data collection time points than others. | Change from baseline balance scores up to a median 14 day hospital length of stay | 
| Falls | The number of falls will be assessed by reviewing medical charts during hospitalization and by self-report at the one month follow-up. | From baseline to 30 days after hospital discharge | 
| Hospital length of stay | Medical chart reviews will be assessed to measure hospital length of stay | From baseline up to a median 14 day hospital length of stay | 
| In-hospital mortality | Medical chart reviews will be assessed to measure in-hospital mortality | From baseline up to a median 14 day hospital length of stay | 
| Hospital readmissions | Medical chart reviews will be assessed to measure readmissions within 30 days. | From baseline up to 30 days after hospital discharge | 
| Safety evaluation (frequency of adverse events) | Safety will be determined through medical chart audit for frequency of adverse events | From baseline up to a median 14 day hospital length of stay | 
| Cost | Costs (Canadian Dollars) related to the interventions will be collected prospectively from the intervention accounts and costs incurred by the healthcare system and patients will be collected through interviews and follow-up surveys, respectively. An appropriate decision-analytic modeling framework will be employed to undertake cost-effectiveness analyses. | From baseline up to 30 days after hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty, Hospitalization, Acute care, older adults, intervention