Measuring Physical Activity Levels in Critical Care
Condition: Critical Care
Study type: Observational

Summary: 
      The study will be a single-centre, prospective observational study to evaluate the use of a
      wearable accelerometer device to measure physical activity levels of patients within critical
      care.
    

Detailed description: 
      The study will be a single-centre, prospective observational study involving patients
      admitted to critical care.

      The study is a feasibility study to evaluate the use of a wearable accelerometer device
      within critical care.

      The study participants will be patients admitted to a single critical care unit. Screening of
      new admissions will be completed and participants recruited according the the
      inclusion/exclusion criteria.

      Participants will not be expected to do anything different to normal as part of the study
      except wear an accelerometer device on their thigh for the duration of their critical care
      admission. This will be applied to the patient by the principle investigator, clinical
      supervisor or member of the critical care research team, as soon as possible after admission.
      This will take place on the critical care unit and will not require the patient to be moved.
      The device will be placed on the participant's right thigh unless this is prohibited by
      lines, wounds or dressings when it will be placed on the left thigh. The device will be
      covered in a waterproof dressing so that it will not need to be removed during routine
      personal care. All devices will be fully charged and calibrated prior to application.

      In addition, once the device is fitted, the critical care the nursing staff looking after the
      participant will fill out a simple record sheet each hour during the day shift to document
      the participant's activity. The activity observation data collection sheet will be based on
      one previously used in a United Kingdom research study. This data is routinely collected by
      physiotherapists on the unit at each therapist-patient contact but is not routinely collected
      hourly by the nursing staff. Recording observed activity will be performed to further explore
      the feasibility of the data collected from the wearable device.

      A priori criteria for feasibility success are recommended by the Consolidated Standards of
      Reporting Trials (CONSORT) statement extension for feasibility trials and as such a wear time
      of 10 hours per day and at least 3 days of data will be considered as the criteria for
      feasibility success.

      Due to the nature of this study, the wearable device needs to be fitted within the first 24
      hours following admission to critical care. This allows the feasibility of using the device
      to be evaluated at all stages of a patient's admission within critical care. It is likely
      that the patients will have undergone intubation and initiation of mechanical ventilation
      during this time. These patients will be sedated as part of their medical management and as
      such will not be able to provide consent prior to inclusion. It may not be appropriate to
      approach the relatives before the first measurement is taken so consent will be waived until
      discussed with an appropriate consultee. A consultee will be approached as soon as is
      appropriate, which will generally be within 48 hours after admission. A consultee will be
      identified after discussion with the participant's family and friends and will be approached
      by either the principal investigator or a member of the Critical Care research team. They
      will be able to advise on the presumed thoughts and wishes of the participant. Consultees
      will be provided with an information sheet and after an appropriate time will be asked to
      sign a consultee declaration form. If the consultee does not wish for the patient to be
      included in the study, any data previously collected will be destroyed.

      Once the participant has regained capacity and is able to provide their consent they will be
      provided with a patient information sheet by the principal investigator or member of the
      critical care research team. The participant will be allowed adequate time (at least 24
      hours) for consideration prior to signing a participant re-consent form.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study participants will be patients admitted to University Hospital Wales critical care
        unit. It is a 33 bedded mixed unit, providing tertiary care for patients from across South
        and West Wales. Nursing care is provided 1:1 for level 3 care and 1:2 for level 2 care.
        Patients present with a wide range of medical conditions including post-surgery,
        polytrauma, respiratory failure and neurological injury. The severity of illness will be
        variable, but patients admitted to critical care will require support for at least one
        organ. The majority of patients are likely to be sedated and mechanically ventilated on
        admission to the unit or shortly afterwards. Patients at high risk of developing physical
        morbidity will be recruited.
      
Keywords: Accelerometry; Wearable electronic devices