Clinical trial NCT02368158: Reha Drive: Predictors of Fitness to Drive a Car for Cardiologic Patients and Determination of Vital Signs
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: myocard infarction
arrhythmia
fitness of driving
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: Philips Electronics Nederland B.V. acting through Philips CTO organization
name: RWTH Aachen Germany Institut fuer Kraftfahrzeuge (IKA)
First posted: 2015-02-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Electrocardiography (ECG)
timeFrame: 30 minutes
measure: Breathing rate (BR)
timeFrame: every 5 minutes for 30 minutes
measure: Heart rate (HR)
timeFrame: every 5 minutes for 30 minutes
measure: Blood pressure
timeFrame: every 5 minutes for 30 minutes
measure: oxygen saturation
timeFrame: 30 minutes
measure: mean deviation of baseline lane
timeFrame: 30 minutes
measure: mean reaction time
timeFrame: 30 minutes
Secondary outcomes:
measure: heart rate (HR)
timeFrame: every 5 minutes for 30 minutes
measure: Breathing rate
timeFrame: every 5 minutes for 30 minutes
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Clinic of Rehabilitation "An der Rosenquelle"
state: North Rhine Westphalia
city: Aachen
country: Germany
facility: Clinic of Cardiology, Angiology, Pneumology and Intensive Medicine, University Hospital Aachen
state: North Rhine Westphalia
Study officials:
affiliation: Department of Cardiology, Angiology, Pneumology and Intensive Medicine, RWTH Aachen University Hospital
name: Sebastian Reith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rehabilitation Clinic "Ander Rosenquelle", Kurbrunnenstreet 5, 52066 Aachen
name: Skobel Erik, MD
role: PRINCIPAL_INVESTIGATOR
References: