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

NCT ID: NCT02368158

Last Updated: 2015-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cardiologic Patient

Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors

Group Type EXPERIMENTAL

Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Philips Electronics Nederland B.V. acting through Philips CTO organization

INDUSTRY

Sponsor Role collaborator

RWTH Aachen Germany Institut fuer Kraftfahrzeuge (IKA)

UNKNOWN

Sponsor Role collaborator

RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sebastian Reith, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Angiology, Pneumology and Intensive Medicine, RWTH Aachen University Hospital

Skobel Erik, MD

Role: PRINCIPAL_INVESTIGATOR

Rehabilitation Clinic "Ander Rosenquelle", Kurbrunnenstreet 5, 52066 Aachen

Locations

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Clinic of Rehabilitation "An der Rosenquelle"

Aachen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Clinic of Cardiology, Angiology, Pneumology and Intensive Medicine, University Hospital Aachen

Aachen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Sebastian Reith, MD

Role: CONTACT

+49 241 80 ext. 35170

Sigrid Gloeggler, M.Sc.

Role: CONTACT

+49 241 80 ext. 35226

Facility Contacts

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Erik Skobel, MD

Role: primary

+49 241 6007 ext. 501

Sigrid Gloeggler, M.Sc.

Role: backup

+49 241 80 ext. 35226

Sebastian Reith, MD

Role: primary

+49 241 80 ext. 35170

Sigrid Gloeggler, M.Sc-

Role: backup

+49 241 80 ext. 35226

Other Identifiers

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CTC-A 13-095

Identifier Type: -

Identifier Source: org_study_id

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