DeliriumTRAVAGE-FAMNCT03732443
FAM-CAM Translation and Validation Into German
An observational study of Delirium and Critical Illness, run by Technical University of Munich at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Critical Illness, Family Members
- What is being tested?
- FAM-CAM
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2019to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients which are at risk for delirium and where assessing of delirium is not limited by language barriers.
Who may be able to join
- Intensive Care Stay ≥ 48 hours
- Expected RASS ≥ 3
- Communication possible in German (minimum of C1 level of Common European Framework of Reference for Languages)
Who cannot join
- preexisting psychosis, dementia or depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translation and Validation of the Family Confusion Assessment Method (FAM-CAM) Into German for the Detection of Delirium in Critically Ill Patients
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.
- Conditions
- Delirium, Critical Illness, Family Members
- Being tested
- FAM-CAM
- Keywords
- Delirium, Family Members, Critical Illness, ABCDEF, Validation, Translation, FAMCAM, CAM-ICU
- Medical subject headings
- Delirium, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAM-CAMDiagnostic test
Family Confusion Assessment Method
| Study group | Role | What they receive |
|---|---|---|
| Critical Ill Patients | Critically ill patients with a RASS ≥ 3. FAM-CAM and CAM-ICU will be administered. Receives: Diagnostic Test: FAM-CAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohen's Kappa Coefficient
Cohen's Kappa coefficient comparing the Family Confusion Assessment Method and the Confusion Assessment Method for Intensive Care Unit
Measured: During a family visit which is not the first while treated in intensive care (an median of 10 days)
Secondary outcomes (4)
Specificity of FAM-CAM
Specificity of the Family Confusion Assessment Method in critically ill patients to detect Delirium
Measured: During a family visit which is not the first while treated in intensive care (an median of 10 days)
Sensitivity of FAM-CAM
Sensitivity of the Family Confusion Assessment Method in critically ill patients to detect Delirium
Measured: During a family visit which is not the first while treated in intensive care (an median of 10 days)
NPV of FAM-CAM
Negative Predictive Value of the Family Confusion Assessment Method in critically ill patients to detect Delirium
Measured: During a family visit which is not the first while treated in intensive care (an median of 10 days)
PPV of FAM-CAM
Positive Predictive Value of the Family Confusion Assessment Method in critically ill patients to detect Delirium
Measured: During a family visit which is not the first while treated in intensive care (an median of 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start1 Jan 2019 (estimated)
- Primary completion28 Feb 2019 (estimated)
- Study completion31 Mar 2019 (estimated)
Why it stopped: Errors in study conception, e.g. sample size calculation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan J Schaller, MD, Principal investigator, Klinikum rechts der Isar der TUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732443
- Sponsor's protocol ID
- TRAVAGE-FAM
- Acronym
- TRAVAGE-FAM
- Status last verified
- Dec 2018
- First submitted
- 29 Oct 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing can be requested for research collaboration purpose or meta-analysis. A data share agreement will have to be signed.
Publications
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.
PubMed 26669904Aya 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.
PubMed 30292069Steis 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.
PubMed 23039310
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation of the Family Confusion Assessment Method (FAM-CAM) Into German for the Detection of Delirium in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03732443
- Acronym / sponsor ID
- TRAVAGE-FAM / TRAVAGE-FAM
- Conditions
- Delirium, Critical Illness, Family Members
- Keywords
- Delirium, Family Members, Critical Illness, ABCDEF, Validation, Translation, FAMCAM, CAM-ICU
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Errors in study conception, e.g. sample size calculation.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critical Ill Patients | – | Diagnostic Test: FAM-CAMCritically ill patients with a RASS ≥ 3. FAM-CAM and CAM-ICU will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients which are at risk for delirium and where assessing of delirium is not limited by language barriers.
Key inclusion criteria (3 listed)
- Intensive Care Stay ≥ 48 hours
- Expected RASS ≥ 3
- Communication possible in German (minimum of C1 level of Common European Framework of Reference for Languages)
Key exclusion criteria (1 listed)
- preexisting psychosis, dementia or depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAM-CAMFamily Confusion Assessment Method | Diagnostic test | Critical Ill Patients |
Primary outcome
Cohen's Kappa Coefficient
Time frame: During a family visit which is not the first while treated in intensive care (an median of 10 days)
Cohen's Kappa coefficient comparing the Family Confusion Assessment Method and the Confusion Assessment Method for Intensive Care Unit
4 secondary outcomes
Specificity of FAM-CAM
Time frame: During a family visit which is not the first while treated in intensive care (an median of 10 days)
Sensitivity of FAM-CAM
Time frame: During a family visit which is not the first while treated in intensive care (an median of 10 days)
NPV of FAM-CAM
Time frame: During a family visit which is not the first while treated in intensive care (an median of 10 days)
PPV of FAM-CAM
Time frame: During a family visit which is not the first while treated in intensive care (an median of 10 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Background: PubMed 26669904Flanagan 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.
- Background: PubMed 30292069Aya 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.
- Background: PubMed 23039310Steis 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.
- Individual participant dataSharing planned: Undecided. Data sharing can be requested for research collaboration purpose or meta-analysis. A data share agreement will have to be signed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan J Schaller, MD principal investigator
Klinikum rechts der Isar der TUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Critical Illness, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohen's Kappa Coefficient (time frame: During a family visit which is not the first while treated in intensive care (an median of 10 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03732443, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018; AzTrials last refreshed its copy on 3 Nov 2026.