Clinical trial NCT02899208: Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients?
Official title: Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Quality of Life
Physical Activity
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the ICU at Zealand University Hospital, Køge, in the study period

Brief summary: This study aims to investigate whether an actigraph, measuring in-hospital activity, used for a week after discharge from the ICU at Zealand University Hospital Køge, can predict physical function at three-month follow up.

The hospital activity will be measured with actigraphy, a measurement tool that quantifies activity level. The activity will be measured for 7 days after ICU discharge. The actigraph is to be worn as a bracelet.

The physical function will be measured with Chelsea Critical Care Physical Assessment Tool (CPAx). CPAx is assessed at ICU discharge and after three months.

Detailed description: Treatment at an Intensive Care Unit (ICU) is often needed for the survival of critically ill patients, but it can take a long time to recover. A number of high quality studies have shown that patients experience functional impairments for a long period after discharge, even for years.

These patients may suffer from a number of other negative influences of their critical illness and ICU stay, e.g. memory problems, episodes of depression, cognitive dysfunction and sleeping disorders. These symptoms are seen in both medical and surgical patients and has been named the Post Intensive Care Syndrome.

Physical rehabilitation is important and must start already during admission, in order to regain some of the function and independence of the patients. This has a well documented effect on both mental and physical wellbeing.

Actigraphy is a newer way of quantifying the activity level continuously. It is validated and has been used in the ICU to assess agitation and sedation and in an oncological, surgical and even an ICU population to assess sleep.

It is easy to use, non-invasive and inexpensive. It is worn like a bracelet and doesn't impair the patients mobility or ambulation.

Another issue when evaluating physical impairments is the choice of method for assessing physical function. For this study, the investigators use the Chelsea Critical Care Physical Assessment Tool (CPAx) as it has good validity and clinimetric properties and is easy to use. Also, it can be done as part of the daily training as it is developed specifically for the ICU.

The aim of this study is to investigate how the in-hospital activity level of patients after ICU discharge is associated with their physical function at three months post discharge.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years of age
* Admitted to the ICU for \> 24 h

Exclusion Criteria:

* Not able to speak and understand Danish
* Patients suffering from dementia or psychosis
* Discharged from the ICU to terminal care
* Patients transferred to another hospital during ICU stay
* Patients living outside the Region of Zealand
* Patients suffering from total paralysis before admission

Primary outcomes:
measure: The association between actigraph levels and CPAx at three months after discharge from ICU
timeFrame: 3 months after discharge from intensive care unit
Secondary outcomes:
measure: CPAx at discharge from ICU
timeFrame: Within 24 hours of discharge from intensive care unit
measure: Activity measured with actigraph during one week after ICU-discharge
timeFrame: One week after discharge from ICU
measure: Association between early activity level measured with actigraphy for 7 days and SF 36 at three months after discharge from ICU
timeFrame: 3 months after discharge from intensive care unit
measure: Association between early activity level measured with actigraphy for 7 days and Hospital Anxiety and Depression Scale (HADS) at three months after discharge from ICU
timeFrame: 3 months after discharge from intensive care unit
measure: Association between early activity level measured with actigraphy for 7 days and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at three months after discharge from ICU
timeFrame: 3 months after discharge from intensive care unit
measure: Association between early activity level measured with actigraphy for 7 days and mortality within hospital stay, after ICU discharge
timeFrame: The period within hospital stay, after intensive care unit discharge
measure: Association between early activity level measured with actigraphy for 7 days and mortality within 90 days after ICU discharge
timeFrame: 3 months after discharge from intensive care unit
measure: Association between early activity level measured with actigraphy for 7 days and consumption of opioids (strong/weak) at 90 days follow up.
timeFrame: 3 months after discharge from intensive care unit
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: Zealand University Hospital, Køge Hospital
name: Stine Estrup, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.
citation: Grap MJ, Borchers CT, Munro CL, Elswick RK Jr, Sessler CN. Actigraphy in the critically ill: correlation with activity, agitation, and sedation. Am J Crit Care. 2005 Jan;14(1):52-60.
citation: Parry SM, Granger CL, Berney S, Jones J, Beach L, El-Ansary D, Koopman R, Denehy L. Assessment of impairment and activity limitations in the critically ill: a systematic review of measurement instruments and their clinimetric properties. Intensive Care Med. 2015 May;41(5):744-62. doi: 10.1007/s00134-015-3672-x. Epub 2015 Feb 5.
citation: Corner EJ, Wood H, Englebretsen C, Thomas A, Grant RL, Nikoletou D, Soni N. The Chelsea critical care physical assessment tool (CPAx): validation of an innovative new tool to measure physical morbidity in the general adult critical care population; an observational proof-of-concept pilot study. Physiotherapy. 2013 Mar;99(1):33-41. doi: 10.1016/j.physio.2012.01.003. Epub 2012 Mar 30.
citation: Corner EJ, Soni N, Handy JM, Brett SJ. Construct validity of the Chelsea critical care physical assessment tool: an observational study of recovery from critical illness. Crit Care. 2014 Mar 27;18(2):R55. doi: 10.1186/cc13801.
citation: Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.