Fatigue One Year After ICU Discharge

Fatigue Clinical Trial

Official title:

Fatigue in Intensive Care Survivors One Year After Discharge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02684877
• Other study ID #: fatigue
• Status: Completed
• Phase: N/A
• First received: February 13, 2016
• Last updated: April 28, 2016
• Start date: January 2015
• Est. completion date: November 2015

Study information

• Verified date: April 2016
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The investigators contacted consecutive adult patients admitted to intensive care unit (ICU) and mechanically ventilated for at least 72 hours to invite them to an interview at hospital. The investigators administered Mini Mental Status Examination, Functional Assessment of Chronic Illness Therapy scale for Fatigue (Facit- F) and Short form 36 questionnaires to the consenting patients.

Description:

Fatigue is one of the most commonly symptoms reported by patients. There are many causes of pathological fatigue including mental and physical, both neurological (central and peripheral) and non-neurological diseases. Among the last ones, cancer, infections and drugs are factors associated with fatigue, although the mechanism of how non-neurological diseases cause fatigue is not clear. Evidence exists to suggest that patients who have been critically ill continue to face a multitude of physical, psychological and social difficulties in the long term after discharge. As far as fatigue is concerned, greater than 50% of Intensive Care Unit survivors overall reported lowered energy levels and fatigue in the first year after discharge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• aged > 18 years

• able to co-operate at the time of ICU discharge

• requiring mechanical ventilation for at least 72 hours

• residents less than 30 km from the hospital

Exclusion Criteria:

• preexisting cognitive deficits

• pre-existing psychotic illness

• admitted for anoxic brain injury

• residents more than 30 km from the hospital

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fatigue

Intervention

Other:
• Questionnaire

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

References & Publications (3)

Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol. 1998 Nov;51(11):1025-36. — View Citation

Egerton T, Riphagen II, Nygård AJ, Thingstad P, Helbostad JL. Systematic content evaluation and review of measurement properties of questionnaires for measuring self-reported fatigue among older people. Qual Life Res. 2015 Sep;24(9):2239-55. doi: 10.1007/s11136-015-0963-1. Epub 2015 Mar 17. — View Citation

Finsterer J, Mahjoub SZ. Fatigue in healthy and diseased individuals. Am J Hosp Palliat Care. 2014 Aug;31(5):562-75. doi: 10.1177/1049909113494748. Epub 2013 Jul 26. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F)		12 months	No
Secondary	Short form 36 questionnaire		12 months	No