Driving Rehabilitation and Innovation for Evaluating Risk in Post-Intensive Care Unit Survivors (DRIVE-PICS)
Study Overview
Status
Status
Conditions
Conditions
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Valerie Danesh, PhD
- Phone Number: 2547714853
- Email: CAHRcriticalcare@bswhealth.org
Study Locations
-
-
Texas
-
Temple, Texas, United States, 76508
- Baylor Scott and White Health Medical Center At Temple
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 40 and older.
- Must have had an ICU stay with delirium.
- Expected to survive hospital discharge.
- English proficiency
- Active driver within 4 weeks prior to index hospitalization
- Regular use of vehicle that is model year 1996 or newer
Exclusion Criteria:
- Communication challenges due to severe pre-existing dementia, hearing, or vision impairment.
- No access to driving.
- Loss or suspension of driver's license
- Current Incarceration
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
|---|
|
Observational Kinematic Driving Data
Longitudinal kinematic driving data paired with neurocognitive assessments at 3- and 6-months
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Driving Time
Time Frame: 0-6 months after hospital discharge
|
Total driving time in minutes.
|
0-6 months after hospital discharge
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression
Time Frame: Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
|
Depression will be measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report of depression symptoms.
Participants rate each item from 0 (not at all) to 3 (very often) to indicate the degree to which they have experienced the symptom in the past 7 days.
Higher scores indicate greater depression.
|
Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
|
|
Executive Function
Time Frame: 3 months after hospital discharge, 6 months after hospital discharge
|
Executive Function will be measured using the Dimensional Change Card Sort.
The participant will be required to sort first according to one dimension (e.g., color) and then according to another dimension (e.g., shape).
|
3 months after hospital discharge, 6 months after hospital discharge
|
|
Attention
Time Frame: 3 months after hospital discharge, 6 months after hospital discharge
|
Attention will be measured using the Flanker Inhibitory Control and Attention Test.
The participants will be required to focus on a given stimulus while inhibiting attention to stimuli.
Sometimes the middle stimulus points in the same direction as the "flankers" (congruent) and sometimes in the opposite direction (incongruent).
if a participant scores ≥ 90%, 20 additional trials with arrows are presented.
|
3 months after hospital discharge, 6 months after hospital discharge
|
|
Working Memory
Time Frame: 3 months after hospital discharge, 6 months after hospital discharge
|
Working memory will be measured using the List Sorting Test.
Participants will be provided pictures of different foods and animals accompanied with an audio recording as well as written text.
The participant will be asked to recall the items back in size order from smallest to largest, first within a single dimension (either animals or foods, called 1-List) and then on two dimensions (foods, then animals, called 2-List).
|
3 months after hospital discharge, 6 months after hospital discharge
|
|
Processing Speed
Time Frame: 3 months after hospital discharge, 6 months after hospital discharge
|
Processing Speed will be measured using the Pattern Comparison Processing Speed Test.
Participants are asked to quickly determine whether two stimuli are the same or not the same.
The participants' score will be based on how many items they answer correctly out of a possible 130 items, completed in 90 seconds.
|
3 months after hospital discharge, 6 months after hospital discharge
|
|
Health-Related Quality of Life
Time Frame: Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
|
Health-Related Quality of Life will be measured using the EuroQol- 5 Dimension Test (EQ-5D).
The participant will be required to answer one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Within the questionnaire, the participants will also be asked to rate their perception of how their health is on a scale of 0 (worst possible health status) to 100 (best possible health status).
Questions are scored as a 1 (full health) and 0 (poorest health).
With 0 being the worst health status.
|
Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
|
|
Anxiety
Time Frame: Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
|
Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report of depression symptoms.
Participants rate each item from 0 (not at all) to 3 (very often) to indicate the degree to which they have experienced the symptom in the past 7 days.
Higher scores indicate greater depression.
|
Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
|
|
Driving Trips
Time Frame: 0-6 months after hospital discharge
|
Driving trips will be measured using the number of trips the participant takes from the beginning of ignition to the end when the vehicle is turned off.
|
0-6 months after hospital discharge
|
|
Driving Behaviors
Time Frame: 0-6 months after hospital discharge
|
Driving behaviors will be measured using near-crash events that are detected with validated accelerometer thresholds.
|
0-6 months after hospital discharge
|
|
Employment
Time Frame: Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
|
Employment will be measured through the Johns Hopkins OACIS Employment Questionnaire.
It is not a scored questionnaire.
|
Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Valerie Danesh, PhD, Baylor Scott and White Research Institute
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 1R21AG080339-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.