Reha Drive: Predictors of Fitness to Drive a Car for Cardiologic Patients and Determination of Vital Signs (RehaDrive)

Reha Drive: Predictors of Fitness to Drive a Car for Cardiologic Patients in Rehabilitation and Acute Clinic and Contactless Determination of Vital Signs Via Camera

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Other: Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors

Detailed Description

Increasing numbers of elderly people with cardiovascular diseases and the wish to drive a car need recommendations corresponding to fitness of driving after their discharge from hospital to home or rehabilitation. A policy paper of the German Cardiac Society (DGK) of 2010 discusses the aptitude of driving a car of cardiovascular patients on experience but only little trial data.Therefore predictors of reduced fitness to drive a car are determined via medical data in comparison to data elevated while "driving" in a simulator and evaluated via Lane Change Test (LCT). Also monitoring of the fitness of driving in the car, automotive monitoring via contactless sensors, could be helpful for judgement.Therefore possible evaluation of heart and breathing rate will be examined with contactless measurements via video camera.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • North Rhine Westphalia
    • Aachen, North Rhine Westphalia, Germany, 52066
      • Recruiting
      • Clinic of Rehabilitation "An der Rosenquelle"
      • Contact: Sigrid Gloeggler, M.Sc.; Phone Number: 35226 +49 241 80; Email: sgloeggler@ukaachen.de
      • Contact: Erik Skobel, MD; Phone Number: 501 +49 241 6007; Email: erik.skobel@rosenquelle.de
    • Aachen, North Rhine Westphalia, Germany, 52074
      • Recruiting
      • Clinic of Cardiology, Angiology, Pneumology and Intensive Medicine, University Hospital Aachen
      • Contact: Sebastian Reith, MD; Phone Number: 35170 +49 241 80; Email: sreith@ukaachen.de
      • Contact: Sigrid Gloeggler, M.Sc-; Phone Number: 35226 +49 241 80; Email: sgloeggler@ukaachen.de
      • Principal Investigator: Sebastian Reith, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• cardiologic disease after acute event (e. g. myocard infarction, bypass surgery, device implantation)
• rehabilitation in clinic "An der Rosenquelle"

Exclusion Criteria:

• dementia
• lack of language ability
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiologic Patient; Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors	Other: Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors; 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
Experimental: Control Proband; The 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	Other: Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate (HR)	feasibility of automotive monitoring of heart and breathing rate via contactless camera	every 5 minutes for 30 minutes
Breathing rate	feasibility of automotive monitoring of heart and breathing rate via contactless camera	every 5 minutes for 30 minutes

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Collaborators: Philips Electronics Nederland B.V. acting through Philips CTO organization; RWTH Aachen Germany Institut fuer Kraftfahrzeuge (IKA)
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: February 4, 2015
• First Submitted That Met QC Criteria: February 19, 2015
• First Posted (Estimate): February 20, 2015

Study Record Updates

• Last Update Posted (Estimate): September 16, 2015
• Last Update Submitted That Met QC Criteria: September 15, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: arrhythmia; myocard infarction; fitness of driving
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: CTC-A 13-095