Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients?

NCT02899208 | Completed DMC

• 1 other identifier: SE 3-16
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Quality of Life; Physical Activity

Outcome Measures

Primary Outcomes (1)

• The association between actigraph levels and CPAx at three months after discharge from ICU

  The association between actigraph levels and CPAx score (from 0 to 50 points)

  3 months after discharge from intensive care unit

Secondary Outcomes (8)

• CPAx at discharge from ICU

  Within 24 hours of discharge from intensive care unit

• Activity measured with actigraph during one week after ICU-discharge

  One week after discharge from ICU

• Association between early activity level measured with actigraphy for 7 days and SF 36 at three months after discharge from ICU

  3 months after discharge from intensive care unit

• 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

  3 months after discharge from intensive care unit

• 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

  3 months after discharge from intensive care unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the ICU at Zealand University Hospital, Køge, in the study period

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital

Køge, 4600, Denmark

Location

Related Publications (6)

• 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.

  PMID: 21470008 BACKGROUND

• 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.

  PMID: 15608109 BACKGROUND

• 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.

  PMID: 25652888 BACKGROUND

• 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.

  PMID: 23219649 BACKGROUND

• 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.

  PMID: 24669784 BACKGROUND

• 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.

  PMID: 24088092 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Motor Activity

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Stine Estrup, MD

  Zealand University Hospital, Køge Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 14, 2016
• Study Start: September 1, 2016
• Primary Completion: May 25, 2017
• Study Completion: May 25, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)