Telehealth-enhanced Patient-oriented Recovery Trajectory After Intensive Care
TelePORT
2 other identifiers
interventional
202
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2023
CompletedFirst Posted
Study publicly available on registry
August 28, 2023
CompletedStudy Start
First participant enrolled
March 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2028
June 12, 2025
June 1, 2025
3.8 years
August 1, 2023
June 9, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
6 months
Secondary Outcomes (7)
Physical function - ADL
6 months
Physical function - IADL
6 months
Physical function - quality of life
6 months
Mental health - PTSD
6 months
Mental health - anxiety/depression
6 months
- +2 more secondary outcomes
Other Outcomes (1)
Post-Traumatic Growth
6 months
Study Arms (2)
Telemedicine ICU Recovery Clinic
EXPERIMENTALscheduled telemedicine study visits 3 weeks and 3 months after hospital discharge or return-to-home if discharged to another facility
Standard Recovery Conditions (i.e., Control)
NO INTERVENTIONControl 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
Multidisciplinary clinic visit that encompasses a medical examination, medication management, neuropsychological exam with focused psychotherapy, case management, and patient-centered consultation.
Eligibility Criteria
You may qualify if:
- Adults (age ≥45)
- Admitted to a medical or surgical ICU
- Treated for ARF (with mechanical ventilation) and/or septic shock (with vasopressors)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt Universitylead
- National Institute on Aging (NIA)collaborator
- Ohio State Universitycollaborator
Study Sites (2)
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Related Publications (2)
Boehm 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.
PMID: 36243061BACKGROUNDBoehm 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.
PMID: 36128790BACKGROUND
Related Links
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Leanne M Boehm, PhD
Vanderbilt University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 1, 2023
First Posted
August 28, 2023
Study Start
March 13, 2024
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
May 31, 2028
Last Updated
June 12, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
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.