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Trial record 1 of 1 for:    NCT02684877
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Fatigue One Year After ICU Discharge

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ClinicalTrials.gov Identifier: NCT02684877
Recruitment Status : Completed
First Posted : February 18, 2016
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):
Savino Spadaro, Università degli Studi di Ferrara

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.

Condition or disease Intervention/treatment
Fatigue Other: Questionnaire

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.

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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fatigue in Intensive Care Survivors One Year After Discharge
Study Start Date : January 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Group/Cohort Intervention/treatment
Intensive care survivors
Observational study
Other: Questionnaire



Primary Outcome Measures :
  1. Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Short form 36 questionnaire [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Intensive care one-year survivors
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
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Savino Spadaro, Physician, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier: NCT02684877    
Other Study ID Numbers: fatigue
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Savino Spadaro, Università degli Studi di Ferrara:
Fatigue
Quality of life
Critically ill patients
Additional relevant MeSH terms:
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Fatigue