NCT04870450

Brief Summary

Due to Covid-19, intensive care (ICU) patients are not allowed visitors or have severely restricted visiting. After being admitted to ICU most patients are unconscious or extremely weak and therefore cannot speak on a phone or video call to a family member. Before these visiting restrictions, family members of patients admitted to ICU as a result of being critically ill were already known to suffer significant psychological distress and may now face increased distress given they are unable to visit a loved one. Previous research demonstrates that keeping a paper diary has been found to be helpful for ICU patients and families. When lockdown measures were announced, NHS Scotland introduced video diaries as an emergency measure to try to support communication with families and reduce distress. vCreate is an NHS Trusted secure video messaging service that helps patients, families and clinical teams stay connected throughout their care journey. The use of video diaries may have a positive impact for family members but there is a risk that they could also have negative effects for some people. There is a need to explore both ICU healthcare professionals and family members' experiences of using video diaries. At the same time it is also important to test the feasibility and acceptability of measures of distress and psychological well-being on family members during and after their experience of video diaries. In doing so, some initial recommendations about video diaries can be made and a larger subsequent study planned to test their effect on family members and healthcare professionals.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 25, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

January 26, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

January 25, 2021

Last Update Submit

April 28, 2021

Conditions

CoronavirusAnxiety Depression

Outcome Measures

Primary Outcomes (1)

  • Qualitative experiences

    The principal aim of this study is to explore the experiences of family members and healthcare professionals in using video diaries during the lockdown and no/very restricted hospital visiting.

    3 months

Secondary Outcomes (3)

  • WEMWBS

    3 months

  • CORE-OM

    3 months

  • Daily Distress Thermometer

    3 months

Study Arms (2)

Healthcare professionals

No intervention. Gathering data on their experiences of using video diaries.

Family members of ICU patients

No intervention. Gathering data on their experiences of using video diaries.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We aim to recruit up to 20 family members who were involved with using video diaries and up to 8 healthcare professionals who supported family members of ICU patients through video diaries. We will recruit family members and healthcare professionals from two of NHS Lothian's ICU's.

You may qualify if:

  • \- (i) Family Members in Lothian aged ≥16 years receiving a video diary for an ICU patient who stays in ICU for ≥24 hours or more. If the patient dies, family members will be invited to continue in the study.
  • (ii) ICU healthcare staff in NHS Lothian who have experience of using the video diary to support family members during lockdown.

You may not qualify if:

  • Prisoners Family members lacking capacity to consent Family members aged under 16 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Edinburgh

Edinburgh, Lothian, EH8 9AG, United Kingdom

RECRUITING

Related Publications (1)

  • Gazzato A, Scquizzato T, Imbriaco G, Negro A, Caballo Garrido MC, Landoni G, Zangrillo A, Borghi G. The Effect of Intensive Care Unit Diaries on Posttraumatic Stress Disorder, Anxiety, and Depression: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Dimens Crit Care Nurs. 2022 Sep-Oct 01;41(5):256-263. doi: 10.1097/DCC.0000000000000539.

    PMID: 35905428DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Central Study Contacts

Sheila Rodgers, PhD

CONTACT

0131650100v1srodg3@ed.ac.uk

Eddie Donaghy, PhD

CONTACT

07766 772645Eddie.donaghy@ed.ac.uk

Study Design

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

Study Record Dates

First Submitted

January 25, 2021

First Posted

May 3, 2021

Study Start

January 26, 2021

Primary Completion

April 30, 2021

Study Completion

June 30, 2021

Last Updated

May 3, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)