An interventional study of Telemedicine ICU Recovery Clinic Visit in Post-intensive Care Syndrome, sponsored by Vanderbilt University. Recruiting at 2 sites in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Vanderbilt University · Not applicable, Interventional, and Treatment
Among 22 studies in postintensive care syndrome with a site in United States — 4 open to participants now, 8 under way, 1 of them phase 3. postintensive care syndrome · United States.
Among the 22 studies in postintensive care syndrome with a site in United States, this one is the 4th largest by planned enrollment of the 15 interventional ones that give a count, is one of 4 that started in 2024, is one of 14 with no phase, and was the 13th registered.
105 studies on the registry are indexed under postintensive care syndrome; 48 are open to participants now.
Browse postintensive care syndrome studies →4 of the 22 studies in postintensive care syndrome with a site in United States are open now. Recruiting first, the newest first:
Medical University of South Carolina · Sites in United States
Ages 18+
Malcom Randall VA Medical Center · Sites in United States
Ages 18–89
University of Rochester · Sites in United States
Ages 7–13
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 29 postintensive care syndrome studies recruiting now, 20 (69%) set no upper age limit and 7 (24%) stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.
This study: 45 Years and older · all sexes · no healthy volunteers.
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22 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 4 started in 2024.
This study's planned enrollment of 202 is above the median of 78 across 47 interventional studies indexed under postintensive care syndrome.
Median enrollment 70 across the 15 interventional studies, 66 across the 7 observational. Of the 12 that completed or were terminated, 3 (25%) have results posted.
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2 of 22 have an industry lead sponsor. The 10 most frequent:
Vanderbilt University is the lead sponsor of 522 studies on the registry; 20 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 5 (63%) have results posted.
Vanderbilt University has 2 studies filed under postintensive care syndrome — fewer than ten, so there is no comparison to draw.
2 of the studies in postintensive care syndrome with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07906366University of RochesterBuilding Resilience Through Anxiety Virtual Education in PICU Survivors | 2027-06-01 |
| NCT03738774Vanderbilt University Medical CenterAddressing Post-Intensive Care Syndrome Among Survivors of COVID (APICS-COVID) | 2027-07 |
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Among the 22 studies in postintensive care syndrome with a site in United States, from their registry updates:
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Intact cognitive skills are necessary for independent living, going to work, and managing finances, and any loss of cognitive skills places a burden on society akin to what is seen with Alzheimer's Disease and Related Dementias. The TelePORT Study (Telehealth-Enhanced Patient-Oriented Recovery Trajectories after Intensive Care) is the first post-intensive care syndrome longitudinal long-term cognitive impairment intervention study. The societal effect from long-term cognitive impairment after critical illness is great as many of these patients are employable adults or functional retirees.
Up to 80% of Intensive Care Unit (ICU) survivors experience cognitive, physical, mental, and socioeconomic impairments, known as Post-Intensive Care Syndrome (PICS), that can last months to years following critical illness and lead to significant reductions in quality of life. Among historical cohorts of acute respiratory distress syndrome and sepsis survivors, as many as 80% demonstrate PICS-related acquired dementia. Likewise, in a broad group of ICU survivors in all adult age groups, 33% to 50% have acquired dementia. ICU Recovery Clinics (ICU-RC) are a feasible and promising intervention to address multifactorial PICS impairments collaboratively, but in-person access is limited. There is an unmet need to study the efficacy of clinics with large cohorts that apply alternative delivery strategies to enhance availability and reach. Older adult (age >=45) ICU survivor is at a combined risk for long-term cognitive impairment (LTCI) among other PICS impairments, and the ideal population to first address this knowledge gap. The investigators hypothesize that a collaborative telemedicine-delivered interdisciplinary ICU-RC intervention effectively identifies and improves LTCI, physical and mental health dysfunction, social integration, and self-management behaviors vs. a control condition with follow-up chosen by the discharge team. Therefore, in a sample of older septic shock and acute respiratory failure survivors, the investigators aim to examine the efficacy of telemedicine ICU-RC services vs. control follow-up chosen by the discharge team in identifying PICS impairments and improving cognitive, physical, and mental health function; and social integration and self-management behaviors at 6 months after hospital discharge. This willl be achieved via a randomized controlled trial of 202 patients randomized 1:1 with age stratification to telemedicine ICU-RC or control (101 per group). Telemedicine recipients will receive a minimum of 2 ICU-RC visits within 3 months of hospital discharge or return to home if discharged to another institution, with additional follow-up determined by the severity of PICS impairment. Cognitive, mental health, and physical outcomes will be measured using the Long-term Core Outcome Measurement Set for ICU survivors in addition to the Social Network Index and Patient Activation Measure. Measures are timed to assess pre-hospital, 1-week post-discharge, and 6-month post-discharge functioning trajectories. This research will provide scientific justification for the continued development, implementation, and scaling of ICU recovery care programs. Ultimately, such knowledge can improve the quality of life for millions of ICU survivors and their family members.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
scheduled telemedicine study visits 3 weeks and 3 months after hospital discharge or return-to-home if discharged to another facility
Behavioral: Telemedicine ICU Recovery Clinic Visit
Control group participants will proceed with follow-up as determined by the discharging hospital team and directed to use the provided PICS guide to connect with commonly used resources.
Multidisciplinary clinic visit that encompasses a medical examination, medication management, neuropsychological exam with focused psychotherapy, case management, and patient-centered consultation.
Cognitive function - MoCA
The Montreal Cognitive Assessment-Blind is a 13-item widely used research measure for cognitive function that assesses memory, attention, language, recall, orientation, and abstraction. Test scores range from 0 (worst) to 22 (best) with a score below 18 being abnormal. Individual tasks on the MoCA-Blind are relatively difficult, reflecting less of a ceiling effect than comparable tools. Among widely used global screening measures, the MoCA has been consistently found to be the most sensitive in identifying even mild expressions of cognitive impairment.
Time frame: 6 months
Cognitive function - PROMIS
The PROMIS Cognitive Function is an 8-item patient-reported outcome measure assessing patient-perceived changes in mental acuity, verbal/nonverbal memory, verbal fluency, and concentration. Raw scores are converted to a standardized T-score with a mean of 50. Higher T-scores indicates better cognitive function.
Time frame: 6 months
Physical function - ADL
Katz's Activities of Daily Living (ADL) is a 6-item self-report of ability to perform ADLs (e.g., bathing, dressing) independently. Items are scored as 0 (dependent) or 1 (independence). Summary scores range from 0-6 with lower scores indicating greater dependence.
Time frame: 6 months
Physical function - IADL
Lawton's Instrumental Activities of Daily Living (IADL) is an 8-item self-report of independence in performing IADLs (e.g., meal preparation, finance management). Items are scored as 0 (dependent) or 1 (independence). Summary scores range from 0-8 with lower scores indicating greater dependence.
Time frame: 6 months
Physical function - quality of life
EuroQol-5D-5L is a 6-item self-report questionnaire of health status. Items are scored on 5 levels of severity ranging from 'no problems' to 'extreme problems' and higher scores indicating worse quality of life.
Time frame: 6 months
Mental health - PTSD
PTSD symptoms will be measured using the Impact of Events Scale-Revised (IES-R), a 22-item tool designed to measure the subjective distress caused by traumatic events. Subjects rate each item from 0 (not at all) to 4 (extremely) to indicate the degree to which they have been bothered by a particular symptom over the past week. Total score is obtained by calculating the mean of all items. Subscale scores can be calculated for avoidance, hyperarousal, and intrusion. Higher scores indicate more distress related to the specific event being evaluated.
Time frame: 6 months
Mental health - anxiety/depression
Depression and Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report. Subjects rate each item from 0 (absence) to 3 (extreme) to indicate the degree to which they have experienced the symptom in the past 7 days. The total possible score ranges from 0-21 per subscale with more than 11 being abnormal.
Time frame: 6 months
Social integration
Berkman-Syme's Social Network Index measure of marital status, friends/family contact, church membership, and group membership. The index considers number and importance of social ties across categories using a summative measure (range: 0-4). For example, there is heavier weighting for intimate contacts (4x the weight of group membership) over church membership (2x the weight of group membership).
Time frame: 6 months
Self management
Patient Activation Measure, a 13-item survey quantifying how much someone is informed about and involved in their health care. The raw score is converted to an activation score (range: 0 \[no activation\] to 100 \[high activation\]). Domains assess importance of active role, confidence and knowledge to take action, taking action, and continuing healthy behaviors under stress.
Time frame: 6 months
Post-Traumatic Growth
Post-Traumatic Growth Inventory, a 21-item scale with higher scores indicating greater post-traumatic growtth
Time frame: 6 months
Plan to share: Yes — Sharing data generated by this project is an essential part of the proposed research. The investigators seek to make data available to the community of scientists interested in ICU recovery care, specifically related to older adults attending ICU-RCs. The TelePORT trial will yield longitudinal outcomes data from approximately 202 adults. The final data set will contain de-identified demographic information and patient outcome responses on PICS, social integration, self-management, and other exploratory outcomes. Data will be available for sharing after the publication date of the main results from the final dataset.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: after study completion
Access criteria: When approval is granted, data-sharing agreements that provide for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed will be instituted. Requests for data must be made in writing and must clearly state the intended use of the requested data and expected length of time for data analyses. This request must be sent directly to the study contact PI who will record all requests for NIH reporting and secure IRB involvement in the process.
Started Mar 2024 (actual). Primary completion is estimated for Dec 2027, 45 months after the start.
Of 39 interventional studies with no phase under postintensive care syndrome, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 38. This study's planned 45 months is above that.
How these figures are worked out, and which studies are left out of them.
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