Recruiting

Telehealth

Sponsor:

Vanderbilt University

Code:

NCT06014931

Conditions

Post-intensive Care Syndrome

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Telemedicine ICU Recovery Clinic Visit

Study Details

Brief summary:

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.

Conditions

Post-intensive Care Syndrome

Study ID

NCT06014931

Start date

Mar 13, 2024

Status verified date

Jul, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults (age ≥45)
  • Admitted to a medical or surgical ICU
  • Treated for ARF (with mechanical ventilation) and/or septic shock (with vasopressors)

Exclusion Criteria:

  • hospice care at discharge or not expected to survive 6 months
  • no access to a computer or electronic device (e.g., tablet, smart phone) with cellular or WiFi connection for a telemedicine clinic visit
  • substance abuse or psych disorder that prevents independent living
  • inability to speak English
  • severe dementia preventing independent living prior to index hospitalization

Study Design

Enrollment

202 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Telemedicine ICU Recovery Clinic

scheduled telemedicine study visits 3 weeks and 3 months after hospital discharge or return-to-home if discharged to another facility

no intervention: Standard Recovery Conditions (i.e., Control)

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.

Interventions

Telemedicine ICU Recovery Clinic Visit

Multidisciplinary clinic visit that encompasses a medical examination, medication management, neuropsychological exam with focused psychotherapy, case management, and patient-centered consultation.

Primary outcome measure

  • Cognitive function - MoCA [ Time Frame: 6 months ]
  • Cognitive function - PROMIS [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Leanne M Boehm, PhD

615-343-1051leanne.boehm@vanderbilt.edu

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

More Information

Sponsor

Vanderbilt University

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University on 2026-07-09.