Cardiovascular DiseasesRehaDriveNCT02368158
Reha Drive: Predictors of Fitness to Drive a Car for Cardiologic Patients and Determination of Vital Signs
A study testing Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors in people with Cardiovascular Diseases, run by RWTH Aachen University at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- cardiologic disease after acute event (e. g. myocard infarction, bypass surgery, device implantation)
- rehabilitation in clinic "An der Rosenquelle"
Who cannot join
- dementia
- lack of language ability
- pregnancy
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Clinic of Rehabilitation "An der Rosenquelle"
Aachen, North Rhine-Westphalia, 52066
Erik Skobel, MD, +49 241 6007 ext. 501, erik.skobel@rosenquelle.de
Sigrid Gloeggler, M.Sc., +49 241 80 ext. 35226, sgloeggler@ukaachen.de
- Recruiting
Clinic of Cardiology, Angiology, Pneumology and Intensive Medicine, University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074
Sebastian Reith, MD, +49 241 80 ext. 35170, sreith@ukaachen.de
Sigrid Gloeggler, M.Sc-, +49 241 80 ext. 35226, sgloeggler@ukaachen.de
About this study
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
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors
- Keywords
- myocard infarction, arrhythmia, fitness of driving
- Medical subject headings
- Cardiovascular Diseases, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensorsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Cardiologic Patient | Experimental | Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors Receives: Other: Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors |
| Control Proband | Experimental | 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 Receives: Other: Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 30 minutes
Secondary outcomes (2)
heart rate (HR)
feasibility of automotive monitoring of heart and breathing rate via contactless camera
Measured: every 5 minutes for 30 minutes
Breathing rate
feasibility of automotive monitoring of heart and breathing rate via contactless camera
Measured: every 5 minutes for 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startOct 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Clinical & Medical Affairs Global
- Responsible party
- Sponsor
- Investigators
- Sebastian Reith, MD, Principal investigator, Department of Cardiology, Angiology, Pneumology and Intensive Medicine, RWTH Aachen University HospitalSkobel Erik, MD, Principal investigator, Rehabilitation Clinic "Ander Rosenquelle", Kurbrunnenstreet 5, 52066 Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368158
- Sponsor's protocol ID
- CTC-A 13-095
- Acronym
- RehaDrive
- Status last verified
- Sep 2015
- First submitted
- 4 Feb 2015
- Last updated
- 16 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02368158
- Acronym / sponsor ID
- RehaDrive / CTC-A 13-095
- Conditions
- Cardiovascular Diseases
- Keywords
- myocard infarction, arrhythmia, fitness of driving
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Philips Clinical & Medical Affairs Global
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 20 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiologic Patient | Experimental | Other: Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensorsDriving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors |
| Control Proband | Experimental | Other: Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensorsThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- cardiologic disease after acute event (e. g. myocard infarction, bypass surgery, device implantation)
- rehabilitation in clinic "An der Rosenquelle"
Key exclusion criteria (3 listed)
- dementia
- lack of language ability
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensorsDuring 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 | Other | Cardiologic Patient, Control Proband |
Primary outcome
Electrocardiography (ECG)
Time frame: 30 minutes
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
Breathing rate (BR)
Time frame: every 5 minutes for 30 minutes
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
Heart rate (HR)
Time frame: every 5 minutes for 30 minutes
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
Blood pressure
Time frame: every 5 minutes for 30 minutes
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
oxygen saturation
Time frame: 30 minutes
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
mean deviation of baseline lane
Time frame: 30 minutes
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
mean reaction time
Time frame: 30 minutes
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
2 secondary outcomes
heart rate (HR)
Time frame: every 5 minutes for 30 minutes
Breathing rate
Time frame: every 5 minutes for 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Reith, MD principal investigator
Department of Cardiology, Angiology, Pneumology and Intensive Medicine, RWTH Aachen University Hospital
Skobel Erik, MD principal investigator
Rehabilitation Clinic "Ander Rosenquelle", Kurbrunnenstreet 5, 52066 Aachen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors in people with Cardiovascular Diseases, run by RWTH Aachen University at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Reith, MD (+49 241 80 ext. 35170, sreith@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrocardiography (ECG) (time frame: 30 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2015.