Telehealth-enhanced Patient-oriented Recovery Trajectory After Intensive Care

ConditionPost-intensive Care Syndrome

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age45+

SponsorVanderbilt University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (age ≥45)

Admitted to a medical or surgical ICU

Treated for ARF (with mechanical ventilation) and/or septic shock (with vasopressors)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Telemedicine ICU Recovery Clinic Visit
Behavioral
Multidisciplinary clinic visit that encompasses a medical examination, medication management, neuropsychological exam with focused psychotherapy, case management, and patient-centered consultation.

Treatment groups

202 Participants

are divided into 2 treatment groups

Group A: Telemedicine ICU Recovery ClinicExperimental treatment 1 intervention

Group B: Standard Recovery Conditions (i.e., Control)No intervention 0 interventions

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

Post-Traumatic Growth

Post-Traumatic Growth Inventory, a 21-item scale with higher scores indicating greater post-traumatic growtth

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Ohio State University

Collaborator

Source ClinicalTrials.gov

Apply now