- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04870450
When Distance is an Act of Love: Exploring the Use of Video Diaries for Family Members of Intensive Care Patients
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sheila Rodgers, PhD
- Phone Number: 0131650100
- Email: v1srodg3@ed.ac.uk
Study Contact Backup
- Name: Eddie Donaghy, PhD
- Phone Number: 07766 772645
- Email: Eddie.donaghy@ed.ac.uk
Study Locations
-
-
Lothian
-
Edinburgh, Lothian, United Kingdom, EH8 9AG
- Recruiting
- University of Edinburgh
-
Contact:
- Sheila Rodgers, PhD
- Phone Number: +44131650100
- Email: v1srodg3@ed.ac.uk
-
Contact:
- Eddie Donaghy, PhD
- Phone Number: +447766772645
- Email: Eddie.donaghy@ed.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative experiences
Time Frame: 3 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
WEMWBS
Time Frame: 3 months
|
(Warwick-Edinburgh Mental Well-being Scale) is a tool that measures psychological well-being.
|
3 months
|
|
CORE-OM
Time Frame: 3 months
|
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
|
|
Daily Distress Thermometer
Time Frame: 3 months
|
The Daily Distress thermometer is an adaptation of the National Comprehensive Cancer Network Distress Thermometer and Problem list.
|
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAHSS2010/07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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