Clinical trial NCT02684877: Fatigue One Year After ICU Discharge
Official title: Fatigue in Intensive Care Survivors One Year After Discharge
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatigue
Keywords: Fatigue
Quality of life
Critically ill patients
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 56
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: Intensive care one-year survivors

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F)
timeFrame: 12 months
Secondary outcomes:
measure: Short form 36 questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
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.
citation: Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol. 1998 Nov;51(11):1025-36. doi: 10.1016/s0895-4356(98)00094-8.
citation: Egerton T, Riphagen II, Nygard 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.
citation: Spadaro S, Capuzzo M, Valpiani G, Bertacchini S, Ragazzi R, Dalla Corte F, Terranova S, Marangoni E, Volta CA. Fatigue in intensive care survivors one year after discharge. Health Qual Life Outcomes. 2016 Oct 18;14(1):148. doi: 10.1186/s12955-016-0554-z.