CoronavirusNCT04870450
When Distance is an Act of Love: Exploring the Use of Video Diaries for Family Members of Intensive Care Patients
An observational study of Coronavirus and Anxiety Depression, run by University of Edinburgh at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus, Anxiety Depression
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jan 2021to 30 Jun 2021
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- (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.
- ICU healthcare staff in NHS Lothian who have experience of using the video diary to support family members during lockdown.
Who cannot join
- Prisoners Family members lacking capacity to consent Family members aged under 16 years
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Edinburgh
Edinburgh, Lothian, EH8 9AG
Sheila Rodgers, PhD, +44131650100, v1srodg3@ed.ac.uk
Eddie Donaghy, PhD, +447766772645, Eddie.donaghy@ed.ac.uk
About this study
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.
- Conditions
- Coronavirus, Anxiety Depression
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
WEMWBS
(Warwick-Edinburgh Mental Well-being Scale) is a tool that measures psychological well-being.
Measured: 3 months
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.
Measured: 3 months
Daily Distress Thermometer
The Daily Distress thermometer is an adaptation of the National Comprehensive Cancer Network Distress Thermometer and Problem list.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start26 Jan 2021
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian, University of Hertfordshire
- Responsible party
- Principal investigator, Sheila Rodgers, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870450
- Sponsor's protocol ID
- CAHSS2010/07
- Status last verified
- Apr 2021
- First submitted
- 25 Jan 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35905428
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- When Distance is an Act of Love: Exploring the Use of Video Diaries for Family Members of Intensive Care Patients
- ClinicalTrials.gov ID
- NCT04870450
- Acronym / sponsor ID
- CAHSS2010/07
- Conditions
- Coronavirus, Anxiety Depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian, University of Hertfordshire
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 3 May 2021 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- (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.
- ICU healthcare staff in NHS Lothian who have experience of using the video diary to support family members during lockdown.
Key exclusion criteria (1 listed)
- Prisoners Family members lacking capacity to consent Family members aged under 16 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcomes
WEMWBS
Time frame: 3 months
CORE-OM
Time frame: 3 months
Daily Distress Thermometer
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Derived from this study: PubMed 35905428Gazzato 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.
- Individual participant dataSharing planned: No
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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.
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 Coronavirus and Anxiety Depression, run by University of Edinburgh at 1 site in United Kingdom.
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 2 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: status not confirmed, as of the sponsor's last update on 3 May 2021. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheila Rodgers, PhD (0131650100, v1srodg3@ed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative experiences (time frame: 3 months). 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 NCT04870450, which also lists 1 linked publication.
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 3 May 2021.