Fatigue One Year After ICU Discharge

NCT ID: NCT02684877

Last Updated: 2016-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fatigue

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intensive care survivors

Observational study

Questionnaire

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionnaire

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Università degli Studi di Ferrara

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Savino Spadaro

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23892338 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9817120 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25778536 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27756403 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

fatigue

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

MICU Recovery Clinic
NCT02560129 COMPLETED