NCT02684877

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
Last Updated

May 2, 2016

Status Verified

April 1, 2016

Enrollment Period

10 months

First QC Date

February 13, 2016

Last Update Submit

April 28, 2016

Conditions

Keywords

FatigueQuality of lifeCritically ill patients

Outcome Measures

Primary Outcomes (1)

  • Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F)

    12 months

Secondary Outcomes (1)

  • Short form 36 questionnaire

    12 months

Study Arms (1)

Intensive care survivors

Observational study

Other: Questionnaire

Interventions

Intensive care survivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Intensive care one-year survivors

You may qualify if:

  • 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

You may not qualify if:

  • preexisting cognitive deficits
  • pre-existing psychotic illness
  • admitted for anoxic brain injury
  • residents more than 30 km from the hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 23892338BACKGROUND
  • 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.

    PMID: 9817120BACKGROUND
  • 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.

    PMID: 25778536BACKGROUND
  • 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.

MeSH Terms

Conditions

Fatigue

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

February 13, 2016

First Posted

February 18, 2016

Study Start

January 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

May 2, 2016

Record last verified: 2016-04