Reha Drive: Predictors of Fitness to Drive a Car for Cardiologic Patients and Determination of Vital Signs
RehaDrive
1 other identifier
interventional
40
1 country
2
Brief Summary
In this study predictors of fitness to drive a car in cardiologic patients after acute intervention and discharge from hospital to home or rehabilitation are determined in addition to possible automotive monitoring of vital signs via contact less sensors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cardiovascular-diseases
Started Oct 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 4, 2015
CompletedFirst Posted
Study publicly available on registry
February 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedSeptember 16, 2015
September 1, 2015
2.2 years
February 4, 2015
September 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Electrocardiography (ECG)
determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test
30 minutes
Breathing rate (BR)
determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test
every 5 minutes for 30 minutes
Heart rate (HR)
determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test
every 5 minutes for 30 minutes
Blood pressure
determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test
every 5 minutes for 30 minutes
oxygen saturation
determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test
30 minutes
mean deviation of baseline lane
determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test
30 minutes
mean reaction time
determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test
30 minutes
Secondary Outcomes (2)
heart rate (HR)
every 5 minutes for 30 minutes
Breathing rate
every 5 minutes for 30 minutes
Study Arms (2)
Cardiologic Patient
EXPERIMENTALDriving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors
Control Proband
EXPERIMENTALThe same intervention as in arm "cardiologic patients" :Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors
Interventions
During a driving simulation medical data are elevated such as electrocardiography (ECG), heart rate breathing rate and oxygen saturation and compared to data of the performed Lane Change Test as a measurement for the quality of driving. Hereby the deviation of the lane from baseline during driving and ordered lane change via signs are determined also when performing cognitive and visual tasks. Also the simulation is simultaneously accompanied by monitoring via contactless camera usage in regard to possible determination of heart and breathing rate according to Eulerian Magnification Method
Eligibility Criteria
You may qualify if:
- cardiologic disease after acute event (e. g. myocard infarction, bypass surgery, device implantation)
- rehabilitation in clinic "An der Rosenquelle"
You may not qualify if:
- dementia
- lack of language ability
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Clinic of Rehabilitation "An der Rosenquelle"
Aachen, North Rhine-Westphalia, 52066, Germany
Clinic of Cardiology, Angiology, Pneumology and Intensive Medicine, University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastian Reith, MD
Department of Cardiology, Angiology, Pneumology and Intensive Medicine, RWTH Aachen University Hospital
- PRINCIPAL INVESTIGATOR
Skobel Erik, MD
Rehabilitation Clinic "Ander Rosenquelle", Kurbrunnenstreet 5, 52066 Aachen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2015
First Posted
February 20, 2015
Study Start
October 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
September 16, 2015
Record last verified: 2015-09