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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04870450
Other study ID # CAHSS2010/07
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 26, 2021
Est. completion date June 30, 2021

Study information

Verified date April 2021
Source University of Edinburgh
Contact Sheila Rodgers, PhD
Phone 0131650100
Email v1srodg3@ed.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date June 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - (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. Exclusion Criteria: Prisoners Family members lacking capacity to consent Family members aged under 16 years

Study Design


Locations

Country Name City State
United Kingdom University of Edinburgh Edinburgh Lothian

Sponsors (3)

Lead Sponsor Collaborator
University of Edinburgh NHS Lothian, University of Hertfordshire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 WEMWBS (Warwick-Edinburgh Mental Well-being Scale) is a tool that measures psychological well-being. 3 months
Secondary CORE-OM CORE-OM (Clinical Outcomes in Routine Evaluation-Outcome Measure) is a self report of a non-proprietary, pan-theoretical (not allied to any particular modality) measure of global psychological distress. 3 months
Secondary Daily Distress Thermometer The Daily Distress thermometer is an adaptation of the National Comprehensive Cancer Network Distress Thermometer and Problem list. 3 months
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