Critical IllnessSOCIALNCT05537311
Reducing Isolation and Feeling of Loneliness During Critical Illness
A study testing Social Engagement in people with Critical Illness and Social Isolation, run by Kirby Mayer at 1 site in United States.
Trial summary
The trial is a pilot-randomized trial testing feasibility and limited-efficacy of delivering social engagement using technologic strategies to reduce periods of social isolation. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Critical Illness, Social Isolation, Anxiety
- What is being tested?
- Social Engagement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2022to 1 Jul 2023
- Phase
- Interventional
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult
- admitted to ICU with acute respiratory failure (ventilation via tube or mask or HFNC)
Who cannot join
- previous cognitive or emotional health condition
- inability to follow commands
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Isolation and Loneliness in Patients With Critical Illness With Novel Engagement Strategies: a Pilot Randomized Trial
The trial is a pilot-randomized trial testing feasibility and limited-efficacy of delivering social engagement using technologic strategies to reduce periods of social isolation.
Read the detailed description
Patients with critical illnesses such as sepsis and acute respiratory failure (ARF) who require an ICU stay are at high risk of developing anxiety, depression, post-traumatic stress disorder, and cognitive deficits. Risk factors for emotional and cognitive impairments after ICU include underlying systematic illness, as well as consequences of life-saving therapies. In brief, patients are frequently restricted and even restrained to the bed, provided high dosages of sedatives, develop delirium, and are isolated from family and staff for extended periods of time. Moreover, the ICU environment including lights, noises, and the social isolation have a serious negative impact on cognitive function and emotional health status. Prospective data from the ICU demonstrate that critically ill patients in ICU spend two-thirds of their time completely alone.
Patients who have survived describe their ICU experience as a traumatic event similar to war, and testimonials for the ICU Recovery clinic frequently resemble: "I felt like I was being held captive in an unknown basement." Periods of social isolation in daily life as well as in the hospital have a significant negative impact on patient-centered outcomes including increased risk of disability, frailty, and mortality. Our study will examine the feasibility of delivering social engagement interventions using technology such as virtual reality (VR) to reduce feelings of isolation and loneliness. There have been a handful of projects to reduce anxiety and depression using a myriad of delivery techniques including journaling in a diary, emotional-behavioral therapy, face-to-face social engagement and family engagement using face-time and VR. These projects, however, have not examined the impact of social engagement on reducing periods of isolation and loneliness. We hypothesize that social engagement delivered using VR technologies will reduce periods of social isolation and thus improve anxiety, depression, and post-traumatic stress disorder (PTSD).
- Conditions
- Critical Illness, Social Isolation, Anxiety, Depression, Post Intensive Care Unit Syndrome
- Being tested
- Social Engagement
- Keywords
- critical illness, Post Intensive Care Unit Syndrome, social isolation
- Medical subject headings
- Critical Illness, Social Isolation, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social EngagementBehavioural
30-45 minutes of social engagement provided to patients in ICU. Social engagement strategies including meaningful conversation, cognitive stimulation, and emotional support
| Study group | Role | What they receive |
|---|---|---|
| Social engagement using VR | Experimental | Patients will receive social engagement with emphasize on meaningful conversation, cognitive engagement, and emotional support provided by trained research assistant using virtual reality as a vehicle for delivery. Subjects will receive 15-45 minutes of treatment per day for 5 days initiated after respiratory support (Intubation via mask or tube, high-flow nasal cannula) have been weaned to nasal cannula. Experimental group will also receive standard of care Receives: Behavioral: Social Engagement |
| Control | No intervention | Control will receive standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of implementing the study intervention
Determine the number of sessions delivered per number of sessions scheduled. The study sample size of 12 subjects to receive the intervention, and each subject in the intervention should receive 5 sessions each = 60 sessions total; success will be considered 75% of sessions delivered (45 sessions completed of 60 planned).
Measured: Through completion of the intervention, which on average will occur one week after randomization
Safety of the study intervention defined as number of patients with treatment-related adverse event
Minor adverse events, major adverse events, and unanticipated problems as assessed by the investigators per study protocol will be recorded during each treatment session. The rate of adverse events will be examined.
Measured: Through completion of the intervention, which on average will occur one week after randomization
Secondary outcomes (4)
Self-reported anxiety
Hospital Anxiety and Depression Scale - Anxiety- self report questionnaire with higher scores indicating worse perceived anxiety
Measured: Through study completion, which will occur on average 1-3 months after hospital discharge
Self-reported depression
Hospital Anxiety and Depression Scale - Depression - self report questionnaire with higher scores indicating worse perceived depression
Measured: Through study completion, which will occur on average 1-3 months after hospital discharge
Self-reported health related quality of life
EurQol-5Domain (EQ-5D) - self report questionnaire with higher scores indicating better perceived quality of life
Measured: Through study completion, which will occur on average 1-3 months after hospital discharge
Cognitive function
Montreal Cognitive Assessment - performed cognitive examination with higher scores indicating better cognitive function
Measured: Through study completion, which will occur on average 1-3 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start27 Jul 2022
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pilot-randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Mayer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kirby Mayer, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537311
- Sponsor's protocol ID
- 77702
- Acronym
- SOCIAL
- Status last verified
- Jul 2023
- First submitted
- 27 Jul 2022
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared via dissemination at national conferences and manuscripts; and available upon request of the primary investigator
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Isolation and Loneliness in Patients With Critical Illness With Novel Engagement Strategies: a Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT05537311
- Acronym / sponsor ID
- SOCIAL / 77702
- Conditions
- Critical Illness, Social Isolation, Anxiety, Depression, Post Intensive Care Unit Syndrome
- Keywords
- critical illness, Post Intensive Care Unit Syndrome, social isolation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Kirby MayerUniversity, hospital or other
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 13 Sep 2022 (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.
The trial is a pilot-randomized trial testing feasibility and limited-efficacy of delivering social engagement using technologic strategies to reduce periods of social isolation.
Detailed description
Patients with critical illnesses such as sepsis and acute respiratory failure (ARF) who require an ICU stay are at high risk of developing anxiety, depression, post-traumatic stress disorder, and cognitive deficits. Risk factors for emotional and cognitive impairments after ICU include underlying systematic illness, as well as consequences of life-saving therapies. In brief, patients are frequently restricted and even restrained to the bed, provided high dosages of sedatives, develop delirium, and are isolated from family and staff for extended periods of time. Moreover, the ICU environment including lights, noises, and the social isolation have a serious negative impact on cognitive function and emotional health status. Prospective data from the ICU demonstrate that critically ill patients in ICU spend two-thirds of their time completely alone.
Patients who have survived describe their ICU experience as a traumatic event similar to war, and testimonials for the ICU Recovery clinic frequently resemble: "I felt like I was being held captive in an unknown basement." Periods of social isolation in daily life as well as in the hospital have a significant negative impact on patient-centered outcomes including increased risk of disability, frailty, and mortality. Our study will examine the feasibility of delivering social engagement interventions using technology such as virtual reality (VR) to reduce feelings of isolation and loneliness. There have been a handful of projects to reduce anxiety and depression using a myriad of delivery techniques including journaling in a diary, emotional-behavioral therapy, face-to-face social engagement and family engagement using face-time and VR. These projects, however, have not examined the impact of social engagement on reducing periods of isolation and loneliness. We hypothesize that social engagement delivered using VR technologies will reduce periods of social isolation and thus improve anxiety, depression, and post-traumatic stress disorder (PTSD).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- pilot-randomized trial
| Arm | Type | Receives |
|---|---|---|
| Social engagement using VR | Experimental | Behavioral: Social EngagementPatients will receive social engagement with emphasize on meaningful conversation, cognitive engagement, and emotional support provided by trained research assistant using virtual reality as a vehicle for delivery. Subjects will receive 15-45 minutes of treatment per day for 5 days initiated after respiratory support (Intubation via mask or tube, high-flow nasal cannula) have been weaned to nasal cannula. Experimental group will also receive standard of care |
| Control | No intervention | –Control will receive standard of care |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult
- admitted to ICU with acute respiratory failure (ventilation via tube or mask or HFNC)
Key exclusion criteria (2 listed)
- previous cognitive or emotional health condition
- inability to follow commands
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Engagement30-45 minutes of social engagement provided to patients in ICU. Social engagement strategies including meaningful conversation, cognitive stimulation, and emotional support | Behavioural | Social engagement using VR |
Primary outcome
Feasibility of implementing the study intervention
Time frame: Through completion of the intervention, which on average will occur one week after randomization
Determine the number of sessions delivered per number of sessions scheduled. The study sample size of 12 subjects to receive the intervention, and each subject in the intervention should receive 5 sessions each = 60 sessions total; success will be considered 75% of sessions delivered (45 sessions completed of 60 planned).
Safety of the study intervention defined as number of patients with treatment-related adverse event
Time frame: Through completion of the intervention, which on average will occur one week after randomization
Minor adverse events, major adverse events, and unanticipated problems as assessed by the investigators per study protocol will be recorded during each treatment session. The rate of adverse events will be examined.
4 secondary outcomes
Self-reported anxiety
Time frame: Through study completion, which will occur on average 1-3 months after hospital discharge
Self-reported depression
Time frame: Through study completion, which will occur on average 1-3 months after hospital discharge
Self-reported health related quality of life
Time frame: Through study completion, which will occur on average 1-3 months after hospital discharge
Cognitive function
Time frame: Through study completion, which will occur on average 1-3 months after hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: Undecided. IPD will be shared via dissemination at national conferences and manuscripts; and available upon request of the primary investigator
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Engagement in people with Critical Illness and Social Isolation, run by Kirby Mayer at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 14 Jul 2023. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of implementing the study intervention (time frame: Through completion of the intervention, which on average will occur one week after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2023.