FAM-CAM Translation and Validation Into German

NCT ID: NCT03732443

Last Updated: 2018-12-20

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-03-31

Brief Summary

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

Validation and Translation of the Family Confusion Assessment Method (FAM-CAM) into German according to Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes of the International Society for Pharmaoeconomics and Outcome Research and comparison to CAM-ICU.

Detailed Description

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

Conditions

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

Delirium Critical Illness Family Members

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Delirium Family Members Critical Illness ABCDEF Validation Translation FAMCAM CAM-ICU

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.

Critical Ill Patients

Critically ill patients with a RASS ≥ 3. FAM-CAM and CAM-ICU will be administered.

FAM-CAM

Intervention Type DIAGNOSTIC_TEST

Family Confusion Assessment Method

Interventions

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

FAM-CAM

Family Confusion Assessment Method

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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

Inclusion Criteria

* Intensive Care Stay ≥ 48 hours
* Expected RASS ≥ 3
* Communication possible in German (minimum of C1 level of Common European Framework of Reference for Languages)

Exclusion Criteria

* preexisting psychosis, dementia or depression
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.

Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stefan J Schaller, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum rechts der Isar der TUM

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Klinikum rechts der Isar der TUM

Munich, Bavaria, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

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

Flanagan NM, Spencer G. Informal caregivers and detection of delirium in postacute care: a correlational study of the confusion assessment method (CAM), confusion assessment method-family assessment method (CAM-FAM) and DSM-IV criteria. Int J Older People Nurs. 2016 Sep;11(3):176-83. doi: 10.1111/opn.12106. Epub 2015 Dec 16.

Reference Type BACKGROUND
PMID: 26669904 (View on PubMed)

Aya AGM, Pouchain PH, Thomas H, Ripart J, Cuvillon P. Incidence of postoperative delirium in elderly ambulatory patients: A prospective evaluation using the FAM-CAM instrument. J Clin Anesth. 2019 Mar;53:35-38. doi: 10.1016/j.jclinane.2018.09.034. Epub 2018 Oct 4.

Reference Type BACKGROUND
PMID: 30292069 (View on PubMed)

Steis MR, Evans L, Hirschman KB, Hanlon A, Fick DM, Flanagan N, Inouye SK. Screening for delirium using family caregivers: convergent validity of the Family Confusion Assessment Method and interviewer-rated Confusion Assessment Method. J Am Geriatr Soc. 2012 Nov;60(11):2121-6. doi: 10.1111/j.1532-5415.2012.04200.x. Epub 2012 Oct 5.

Reference Type BACKGROUND
PMID: 23039310 (View on PubMed)

Other Identifiers

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

TRAVAGE-FAM

Identifier Type: -

Identifier Source: org_study_id