NCT02931851: ICU-Families

Family Information Management in the Intensive Care Unit

Terminated NA Last updated 14 June 2022

What this trial tests

NA trial testing ICU Families Website in Extended Family in 75 participants. Terminated before completion.

Timeline

1 May 2015

Primary endpoint
15 December 2020

15 December 2020

Quick facts

Lead sponsor	Medical University of Graz
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	75
Start date	1 May 2015
Primary completion	15 December 2020
Estimated completion	15 December 2020
Sites	3 locations across Austria, Switzerland

Drugs / interventions tested

• ICU Families Website
• Placebo

Conditions studied

• Extended Family — all drugs for Extended Family →

Sponsor

Medical University of Graz

Who can join

Adults 18 to 100, any sex, with Extended Family. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Relatives in intensive care units (ICU) are important partners in decision-making in the treatment of critically ill patients and provide a significant resource in the care and recovery of patients. Therefore, a professional, educational intervention targeting these caregivers may have fundamental benefits with little risk. As in other fields, information is searched in the internet, but this unselected information is often overwhelming and of little use in this context.

Symptoms of anxiety, stress and depression are common in affected relatives. The majority of family members report some level of anxiety, depression and stress, sometimes even resulting in post-traumatic stress disorder (PTSD). Importantly, an association between lack of information and post-traumatic stress disorder PTSD has been reported. The large number of potentially affected families poses a particular challenge to healthcare and may cause substantial secondary costs to national economy.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. ESICM LIVES 2018 : Paris, France. 20-24 October 2018.
   · 2018 · cited 16× · PMID 30341496 · DOI 10.1186/s40635-018-0201-6
2. Information or education interventions for adult intensive care unit (ICU) patients and their carers.
   Lewis SR, Pritchard MW, Schofield-Robinson OJ, Evans DJ, et al · · 2018 · cited 11× · PMID 30316199 · DOI 10.1002/14651858.cd012471.pub2
3. Prioritizing information topics for relatives of critically ill patients : Cross-sectional survey among intensive care unit relatives and professionals.
   Hoffmann M, Holl AK, Burgsteiner H, Eller P, et al · · 2018 · cited 10× · PMID 30094664 · DOI 10.1007/s00508-018-1377-1
4. ESICM LIVES 2019 : Berlin, Germany. 28 September - 2 October 2019.
   · 2019 · cited 8× · PMID 31559498 · DOI 10.1186/s40635-019-0265-y