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

Cardiovascular Diseases Clinical Trial

— RehaDrive  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02368158
• Other study ID #: CTC-A 13-095
• Status: Recruiting
• Phase: N/A
• First received: February 4, 2015
• Last updated: September 15, 2015
• Start date: October 2013
• Est. completion date: December 2015

Study information

• Verified date: September 2015
• Source: RWTH Aachen University
• Contact: Sebastian Reith, MD
• Phone: +49 241 80
• Email: sreith[@]ukaachen.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
Germany	Clinic of Cardiology, Angiology, Pneumology and Intensive Medicine, University Hospital Aachen	Aachen	North Rhine Westphalia
Germany	Clinic of Rehabilitation "An der Rosenquelle"	Aachen	North Rhine Westphalia

Sponsors (3)

Lead Sponsor	Collaborator
RWTH Aachen University	Philips Research, RWTH Aachen Germany Institut fuer Kraftfahrzeuge (IKA)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	No
Primary	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	No
Secondary	heart rate (HR)	feasibility of automotive monitoring of heart and breathing rate via contactless camera	every 5 minutes for 30 minutes	No
Secondary	Breathing rate	feasibility of automotive monitoring of heart and breathing rate via contactless camera	every 5 minutes for 30 minutes	No