Critical IllnessTelePORTNCT03926533
TelePORT Pilot Study
A study testing Telehealth in people with Critical Illness and Acute Respiratory Distress Syndrome, run by Vanderbilt University at 1 site in United States.
Trial summary
Although more than 50% of survivors of critical illness experience one or more post-intensive care syndrome (PICS) problems, there are still no validated interventions for the management of PICS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Acute Respiratory Distress Syndrome, Septic Shock
- What is being tested?
- Telehealth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 28 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- index ICU stay with a diagnosis of sepsis or acute respiratory distress syndrome projected to be discharged alive as these patients are at the highest risk for developing PICS
Who cannot join
- no access to computer, electronic device (e.g., tablet, smartphone), and/or internet connection for virtual clinic visit,
- primary care received outside of VUMC network,
- hospice care at discharge,
- substance abuse or psychiatric disorder that prevents independent living,
- blind, deaf, unable to speak English, or
- severe dementia prior to index hospitalization
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37129
About this study
Official title: Telehealth-Enhanced Patient-Oriented Recovery Trajectory After Intensive Care Pilot Feasibility Study
Although more than 50% of survivors of critical illness experience one or more post-intensive care syndrome (PICS) problems, there are still no validated interventions for the management of PICS. The long-term goal of this study is to develop and refine in-person and telehealth strategies for the delivery of Intensive Care Unit (ICU) recovery care for the treatment of PICS.
Read the detailed description
The overall objectives in this application are to (a) examine the feasibility of providing telehealth ICU recovery care and (b) determine if ICU recovery care is effective. The central hypothesis is that ICU recovery care improves cognitive, mental health, and physical function of ICU survivors by application of a patient-centered survivorship care plan with targeted interventions to address patient-specific cognitive, mental health, and physical dysfunctions. The rationale for this project is that a determination of the feasibility of telehealth and effectiveness of ICU recovery care in general is likely to offer a strong scientific framework informing the development of new implementation strategies. We will test the central hypotheses by pursuing two specific aims: 1) Test that telehealth ICU recovery care is feasible, and 2) Test the hypothesis that telehealth ICU recovery care compared to standard of care conditions will be more effective for improvement in cognitive, mental health, physical, and global function at 6 months following hospital discharge. To address these aims, we will enroll patients treated for septic shock and acute respiratory distress syndrome in the medical and surgical ICUs at Vanderbilt University Medical Center. Study patients will be randomized 1:1 to either the telehealth ICU recovery care or standard of care groups. We will conduct telehealth ICU recovery care from the Vanderbilt ICU Recovery Center. This ICU survivor clinic relies on the expertise of clinicians from critical care medicine, nursing, pharmacy, neuropsychology, rehabilitation, and case management to assess and manage PICS. Telehealth feasibility measures include appropriateness, acceptability, and implementability. Following telehealth clinic participation at 3 weeks and 3 months after hospital discharge, we will assess participants for cognitive, mental health, physical, and global quality of life outcomes using trained, blinded research personnel at 6 months following hospital discharge. We incorporated PROMIS patient-centered outcome measures into each patient outcome category. This research is significant because it is expected to provide scientific justification for the continued development and implementation of ICU recovery care programs. Ultimately, such knowledge has the potential to improve the quality of life for millions of ICU survivors and their family members.
- Being tested
- Telehealth
- Keywords
- Post-Intensive Care Syndrome
- Medical subject headings
- Critical Illness, Respiratory Distress Syndrome, Shock, Septic, postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelehealthOther
Telehealth visits will be conducted from a private telehealth lab room in the Vanderbilt ICU Recovery Center using a live and interactive approach where providers and patients interact and communicate in real-time using Zoom, a secure video-conferencing platform recommended by Vanderbilt Telehealth.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth ICU Recovery Program | Experimental | Components of the ICU RC telehealth visit will be structured parallel to what is done during a typical in-person clinic visit. The telehealth intervention consists of 5 chronological components conducted during two 1.5 hour telehealth clinic visits (the same time required for an in-person visit). Upon completion of the pre-intervention baseline assessment, the study coordinator will contact patients randomized to the intervention arm to schedule the first telehealth visit. Study visits will occur at 3 weeks and 3 months following hospital discharge. Receives: Other: Telehealth |
| Standard Recovery Conditions | No intervention | participants assigned to the standard of care control group will be contacted by the study coordinator to ensure the patient has a primary care and/or specialist appointment scheduled. At this time, patients will also receive an electronic PICS guide for ICU survivors created by the Society of Critical Care Medicine. Patients will be directed to use the information provided in the PICS guide for ICU survivors to connect with resources. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
participants will complete the 4-item Likert response Acceptability of Intervention Measure (AIM) of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree = 1 Completely Agree = 5 ). Higher scores indicate greater acceptability. Scores are based on calculated mean.
Measured: 6 months
participants will complete the 4-item Likert response Feasibility of Intervention Measure (FIM)
participants will complete the 4-item Likert response Feasibility of Intervention Measure (FIM) of perceived intervention feasibility. Items are measured on a 5-point Likert scale (Completely Disagree = 1 Completely Agree = 5 ). Higher scores indicate greater feasibility. Scores are based on calculated mean.
Measured: 6 months
Appropriateness
participants will complete the 4-item Likert response Intervention Appropriateness Measure (IAM) of perceived intervention appropriateness. Items are measured on a 5-point Likert scale (Completely Disagree = 1 Completely Agree = 5 ). Higher scores indicate greater appropriateness. Scores are based on calculated mean.
Measured: 6 months
Secondary outcomes (6)
cognitive impairment
The MOCA-Blind is a 13-item widely used measure in research to evaluate for cognitive impairment. The MOCA-Blind assesses memory, attention, language, recall, orientation, and abstraction where total test score ranges from 0 (worst) to 22 (best) and a score below 18 is considered abnormal. The PROMIS Cognitive Function Short-Form v2.0 is an 8-item patient-reported outcome measure that assesses patient-perceived changes in mental acuity, verbal and nonverbal memory, concentration, and verbal fluency. Raw scores are converted to a T-score which rescales the raw score into a standardized score with a mean of 50 (+/-10). Higher T-scores indicates higher function.
Measured: 6 months
depression
Depression will be measured using the PROMIS Depression v1.0, an 8-item self-report of negative mood, views of self, social cognition, and decreased positive affect and engagement. Subjects rate each item from 1 (never) to 5 (always) to indicate the degree to which they have experienced the symptom in the past 7 days. Raw scores for PROMIS Depression are converted to a T-score which rescales the raw score into a standardized score with a mean of 50 (+/-10). Higher T-scores indicate greater depression.
Measured: 6 months
physical impairments
PROMIS Physical Function v2.0, a 20-item self-report of physical capability rather than actual performance of physical activities (e.g., dexterity, mobility). Subjects rate each item from 1 (unable to do) to 5 (without any difficulty) for their current capability. Raw scores are converted to a T-score which rescales the raw score into a standardized score with a mean of 50 (+/-10). Higher T-scores indicate better function. Respiratory function will be measured using the St. George Respiratory Questionnaire (SGRQ), a 40-item self-report questionnaire evaluating pulmonary function, symptoms, and the impact on daily life. Scores range from 0 (no impairment) to 80 (maximum health impairment).
Measured: 6 months
QOL
PROMIS Global Short Form v1.1, a 10-item self-reported measure of health-related quality of life. Subjects rate each item from 1 (poor) to 5 (excellent) for their current health and quality of life with the exception of question #10 which rates pain from 0 (no pain) to 10 (worst imaginable pain). Raw scores are converted to a T-score which rescales the raw score into a standardized score with a mean of 50 (+/-10). Higher T-scores indicate better health-related quality of life.
Measured: 6 months
anxiety
Anxiety will be measured using the PROMIS Anxiety v1.0, an 8-item self-report of fear, anxious misery, hyperarousal, and somatic symptoms. Similar to depression, subjects rate each item from 1 (never) to 5 (always) to indicate the degree to which they have experienced the symptom in the past 7 days. Raw scores for PROMIS Anxiety are converted to a T-score which rescales the raw score into a standardized score with a mean of 50 (+/-10). Higher T-scores indicate greater anxiety.
Measured: 6 months
PTSD symptoms will be measured using the PTSD Checklist for DSM-5 (PCL-5)
PTSD symptoms will be measured using the PTSD Checklist for DSM-5 (PCL-5), a 20-item brief screening tool assessing symptoms of PTSD associated with pre-specified traumatic event (i.e., critical illness), corresponds to the DSM-5 diagnostic criteria for PTSD, and has excellent reliability and sensitivity. Subjects rate each item from 1 (not at all) to 5 (extremely) to indicate the degree to which they have been bothered by a particular symptom over the past month. The total possible score ranges from 0-80 with higher scores indicating more severe symptoms and a cut-off of 50 optimal for indicating a probable diagnosis of PTSD.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start1 Nov 2019
- Primary completion31 Jan 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- American Association of Critical Care Nurses, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Leanne M Boehm, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926533
- Sponsor's protocol ID
- 190790
- Acronym
- TelePORT
- Status last verified
- Aug 2023
- First submitted
- 22 Apr 2019
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boehm LM, Danesh V, LaNoue M, Trochez RJ, Jones AC, Kimpel CC, Sevin CM. Factors Influencing Engagement with in-Person Intensive Care Unit Recovery Clinic Services. J Intensive Care Med. 2023 Apr;38(4):375-381. doi: 10.1177/08850666221127154. Epub 2022 Sep 21.
PubMed 36128790Boehm LM, Danesh V, Eaton TL, McPeake J, Pena MA, Bonnet KR, Stollings JL, Jones AC, Schlundt DG, Sevin CM. Multidisciplinary ICU Recovery Clinic Visits: A Qualitative Analysis of Patient-Provider Dialogues. Chest. 2023 Apr;163(4):843-854. doi: 10.1016/j.chest.2022.10.001. Epub 2022 Oct 13.
PubMed 36243061Kovaleva MA, Jones AC, Kimpel CC, Lauderdale J, Sevin CM, Stollings JL, Jackson JC, Boehm LM. Patient and caregiver experiences with a telemedicine intensive care unit recovery clinic. Heart Lung. 2023 Mar-Apr;58:47-53. doi: 10.1016/j.hrtlng.2022.11.002. Epub 2022 Nov 15.
PubMed 36399862Kovaleva MA, Jones AC, Kimpel CC, Lauderdale JL, Sevin CM, Boehm LM. Patients' and Caregivers' Perceptions of Intensive Care Unit Hospitalization and Recovery. Am J Crit Care. 2022 Jul 1;31(4):319-323. doi: 10.4037/ajcc2022945.
PubMed 35773198Boehm LM, You H, Siao SF, D LaNoue M, Jones AC, Piras SE, Garrett A, Dodson AB, Stollings JL, Jackson JC, Sevin CM. Multidisciplinary telemedicine intervention for ICU recovery: the TelePORT feasibility randomized trial. Crit Care. 2026 Jun 27. doi: 10.1186/s13054-026-06154-y. Online ahead of print.
PubMed 42365340Eaton TL, Danesh V, Jones AC, Kimpel CC, Sevin CM, Su H, Toth KM, Valley TS, Iwashyna TJ, Boehm LM, McPeake J. Clinician and Patient Responses to US Health Insurers' Policies: A Qualitative Study of Higher Risk Patients. Health Serv Res. 2025 Jun;60(3):e14615. doi: 10.1111/1475-6773.14615. Epub 2025 Apr 24.
PubMed 40275640Hussain AA, Jones AC, Hosey MM, Kiehl A, Danesh V, McPeake J, Toth K, Eaton TL, Su H, Jackson JC, Boehm LM. Patient-psychologist telemedicine interactions in an intensive care unit recovery clinic: Qualitative secondary analysis. Intensive Crit Care Nurs. 2025 Apr;87:103886. doi: 10.1016/j.iccn.2024.103886. Epub 2024 Nov 21.
PubMed 39577128Carter SJ, Lauderdale J, Stollings JL, Sevin CM, Cunningham-Erves J, Kokoy S, Clouse K, Boehm LM. Factors Influencing Influenza and COVID-19 Vaccine Decision-Making in the Post-ICU Period: A Secondary Analysis. CHEST Crit Care. 2023 Dec;1(3):100027. doi: 10.1016/j.chstcc.2023.100027. Epub 2023 Oct 23.
PubMed 38188262Danesh V, McDonald AD, McPeake J, Eaton TL, Potter K, Su H, Jackson JC, Boehm LM. Driving decisions after critical illness: Qualitative analysis of patient-provider reviews during ICU recovery clinic assessments. Int J Nurs Stud. 2023 Oct;146:104560. doi: 10.1016/j.ijnurstu.2023.104560. Epub 2023 Jul 4.
PubMed 37531701
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth-Enhanced Patient-Oriented Recovery Trajectory After Intensive Care Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT03926533
- Acronym / sponsor ID
- TelePORT / 190790
- Keywords
- Post-Intensive Care Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- American Association of Critical Care Nurses, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 24 Apr 2019 (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.
Although more than 50% of survivors of critical illness experience one or more post-intensive care syndrome (PICS) problems, there are still no validated interventions for the management of PICS. The long-term goal of this study is to develop and refine in-person and telehealth strategies for the delivery of Intensive Care Unit (ICU) recovery care for the treatment of PICS.
Detailed description
The overall objectives in this application are to (a) examine the feasibility of providing telehealth ICU recovery care and (b) determine if ICU recovery care is effective. The central hypothesis is that ICU recovery care improves cognitive, mental health, and physical function of ICU survivors by application of a patient-centered survivorship care plan with targeted interventions to address patient-specific cognitive, mental health, and physical dysfunctions. The rationale for this project is that a determination of the feasibility of telehealth and effectiveness of ICU recovery care in general is likely to offer a strong scientific framework informing the development of new implementation strategies. We will test the central hypotheses by pursuing two specific aims: 1) Test that telehealth ICU recovery care is feasible, and 2) Test the hypothesis that telehealth ICU recovery care compared to standard of care conditions will be more effective for improvement in cognitive, mental health, physical, and global function at 6 months following hospital discharge. To address these aims, we will enroll patients treated for septic shock and acute respiratory distress syndrome in the medical and surgical ICUs at Vanderbilt University Medical Center. Study patients will be randomized 1:1 to either the telehealth ICU recovery care or standard of care groups. We will conduct telehealth ICU recovery care from the Vanderbilt ICU Recovery Center. This ICU survivor clinic relies on the expertise of clinicians from critical care medicine, nursing, pharmacy, neuropsychology, rehabilitation, and case management to assess and manage PICS. Telehealth feasibility measures include appropriateness, acceptability, and implementability. Following telehealth clinic participation at 3 weeks and 3 months after hospital discharge, we will assess participants for cognitive, mental health, physical, and global quality of life outcomes using trained, blinded research personnel at 6 months following hospital discharge. We incorporated PROMIS patient-centered outcome measures into each patient outcome category. This research is significant because it is expected to provide scientific justification for the continued development and implementation of ICU recovery care programs. Ultimately, such knowledge has the potential to improve the quality of life for millions of ICU survivors and their family members.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth ICU Recovery Program | Experimental | Other: TelehealthComponents of the ICU RC telehealth visit will be structured parallel to what is done during a typical in-person clinic visit. The telehealth intervention consists of 5 chronological components conducted during two 1.5 hour telehealth clinic visits (the same time required for an in-person visit). Upon completion of the pre-intervention baseline assessment, the study coordinator will contact patients randomized to the intervention arm to schedule the first telehealth visit. Study visits will occur at 3 weeks and 3 months following hospital discharge. |
| Standard Recovery Conditions | No intervention | –participants assigned to the standard of care control group will be contacted by the study coordinator to ensure the patient has a primary care and/or specialist appointment scheduled. At this time, patients will also receive an electronic PICS guide for ICU survivors created by the Society of Critical Care Medicine. Patients will be directed to use the information provided in the PICS guide for ICU survivors to connect with resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- index ICU stay with a diagnosis of sepsis or acute respiratory distress syndrome projected to be discharged alive as these patients are at the highest risk for developing PICS
Key exclusion criteria (6 listed)
- no access to computer, electronic device (e.g., tablet, smartphone), and/or internet connection for virtual clinic visit,
- primary care received outside of VUMC network,
- hospice care at discharge,
- substance abuse or psychiatric disorder that prevents independent living,
- blind, deaf, unable to speak English, or
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 |
|---|---|---|
| TelehealthTelehealth visits will be conducted from a private telehealth lab room in the Vanderbilt ICU Recovery Center using a live and interactive approach where providers and patients interact and communicate in real-time using Zoom, a secure video-conferencing platform recommended by Vanderbilt Telehealth. | Other | Telehealth ICU Recovery Program |
Primary outcome
Acceptability
Time frame: 6 months
participants will complete the 4-item Likert response Acceptability of Intervention Measure (AIM) of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree = 1 Completely Agree = 5 ). Higher scores indicate greater acceptability. Scores are based on calculated mean.
participants will complete the 4-item Likert response Feasibility of Intervention Measure (FIM)
Time frame: 6 months
participants will complete the 4-item Likert response Feasibility of Intervention Measure (FIM) of perceived intervention feasibility. Items are measured on a 5-point Likert scale (Completely Disagree = 1 Completely Agree = 5 ). Higher scores indicate greater feasibility. Scores are based on calculated mean.
Appropriateness
Time frame: 6 months
participants will complete the 4-item Likert response Intervention Appropriateness Measure (IAM) of perceived intervention appropriateness. Items are measured on a 5-point Likert scale (Completely Disagree = 1 Completely Agree = 5 ). Higher scores indicate greater appropriateness. Scores are based on calculated mean.
6 secondary outcomes
cognitive impairment
Time frame: 6 months
depression
Time frame: 6 months
physical impairments
Time frame: 6 months
QOL
Time frame: 6 months
anxiety
Time frame: 6 months
PTSD symptoms will be measured using the PTSD Checklist for DSM-5 (PCL-5)
Time frame: 6 months
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 3 Aug 2023.
- Background: PubMed 36128790Boehm LM, Danesh V, LaNoue M, Trochez RJ, Jones AC, Kimpel CC, Sevin CM. Factors Influencing Engagement with in-Person Intensive Care Unit Recovery Clinic Services. J Intensive Care Med. 2023 Apr;38(4):375-381. doi: 10.1177/08850666221127154. Epub 2022 Sep 21.
- Results publication: PubMed 36243061Boehm LM, Danesh V, Eaton TL, McPeake J, Pena MA, Bonnet KR, Stollings JL, Jones AC, Schlundt DG, Sevin CM. Multidisciplinary ICU Recovery Clinic Visits: A Qualitative Analysis of Patient-Provider Dialogues. Chest. 2023 Apr;163(4):843-854. doi: 10.1016/j.chest.2022.10.001. Epub 2022 Oct 13.
- Results publication: PubMed 36399862Kovaleva MA, Jones AC, Kimpel CC, Lauderdale J, Sevin CM, Stollings JL, Jackson JC, Boehm LM. Patient and caregiver experiences with a telemedicine intensive care unit recovery clinic. Heart Lung. 2023 Mar-Apr;58:47-53. doi: 10.1016/j.hrtlng.2022.11.002. Epub 2022 Nov 15.
- Results publication: PubMed 35773198Kovaleva MA, Jones AC, Kimpel CC, Lauderdale JL, Sevin CM, Boehm LM. Patients' and Caregivers' Perceptions of Intensive Care Unit Hospitalization and Recovery. Am J Crit Care. 2022 Jul 1;31(4):319-323. doi: 10.4037/ajcc2022945.
- Derived from this study: PubMed 42365340Boehm LM, You H, Siao SF, D LaNoue M, Jones AC, Piras SE, Garrett A, Dodson AB, Stollings JL, Jackson JC, Sevin CM. Multidisciplinary telemedicine intervention for ICU recovery: the TelePORT feasibility randomized trial. Crit Care. 2026 Jun 27. doi: 10.1186/s13054-026-06154-y. Online ahead of print.
- Derived from this study: PubMed 40275640Eaton TL, Danesh V, Jones AC, Kimpel CC, Sevin CM, Su H, Toth KM, Valley TS, Iwashyna TJ, Boehm LM, McPeake J. Clinician and Patient Responses to US Health Insurers' Policies: A Qualitative Study of Higher Risk Patients. Health Serv Res. 2025 Jun;60(3):e14615. doi: 10.1111/1475-6773.14615. Epub 2025 Apr 24.
- Derived from this study: PubMed 39577128Hussain AA, Jones AC, Hosey MM, Kiehl A, Danesh V, McPeake J, Toth K, Eaton TL, Su H, Jackson JC, Boehm LM. Patient-psychologist telemedicine interactions in an intensive care unit recovery clinic: Qualitative secondary analysis. Intensive Crit Care Nurs. 2025 Apr;87:103886. doi: 10.1016/j.iccn.2024.103886. Epub 2024 Nov 21.
- Derived from this study: PubMed 38188262Carter SJ, Lauderdale J, Stollings JL, Sevin CM, Cunningham-Erves J, Kokoy S, Clouse K, Boehm LM. Factors Influencing Influenza and COVID-19 Vaccine Decision-Making in the Post-ICU Period: A Secondary Analysis. CHEST Crit Care. 2023 Dec;1(3):100027. doi: 10.1016/j.chstcc.2023.100027. Epub 2023 Oct 23.
- Derived from this study: PubMed 37531701Danesh V, McDonald AD, McPeake J, Eaton TL, Potter K, Su H, Jackson JC, Boehm LM. Driving decisions after critical illness: Qualitative analysis of patient-provider reviews during ICU recovery clinic assessments. Int J Nurs Stud. 2023 Oct;146:104560. doi: 10.1016/j.ijnurstu.2023.104560. Epub 2023 Jul 4.
- The ICU Recovery Center at VanderbiltLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Critical Illness
Recruiting
Cycling Within an Interactive and Immersive Virtual Environment During Critical Illness: a Patient-centred Approach for Lower Limb Rehabilitation
Critical Illness
Not yet recruitingObservational study
Dynamic Inflammatory Changes and Nutritional Risk Scores in ICU Patients Aged 65 Years and Older
Critical Illness, Geriatric Patient
Recruiting
Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock
Critical Illness, Shock
Recruiting
Characterization and Longitudinal Monitoring of Muscular Phenotype in Patients Admitted to Intensive Care for Sepsis
Sepsis, Myopathy Critical Illness
Not yet recruitingObservational study
Stress Hyperglycemia Ratio and Glucose Variability in Critically Ill Patients
Critical Illness, Hyperglycemia
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 Telehealth in people with Critical Illness and Acute Respiratory Distress Syndrome, run by Vanderbilt University 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 1 inclusion and 6 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 3 Aug 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?
Acceptability (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT03926533, which also lists 9 linked publications.
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 Aug 2023.