Feasibility of Telemedical Home MonitoringNCT01175057
MeDiNa Pilot Study for Evaluation of the MeDiNa Concept of Homely Rehabilitation After Myocardial Infarction
An observational study of Feasibility of Telemedical Home Monitoring and Post Stationary, run by RWTH Aachen University at 1 site in Germany.
Trial summary
In this study feasibility of the MeDiNa concept is looked at, which means telemedical services for homely rehabilitation. With the help of microsystems technology, the relevant vital signs are measured at the patient's home, then transmitted to the MeDiNa- Homebox- Tablet PC (by bluetooth) and then transferred into a… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Feasibility of Telemedical Home Monitoring, Post Stationary, Patients With Myocardial Infarction
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2011to Sep 2012
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of the Medical Clinic I, RWTH Aachen University Hospital, Pauwelsstaße 30, 52074 Aachen, post stationary after myocardial infarction and who are at least 60 years old
Who may be able to join
- female and male patients minimum 60 years old
- myocardial infarction
- post stationary rehabilitation at home
- Internet access or mobile phone reception possible
- able to give informed consent
Who cannot join
- patients with dementia
- aphasic impairment
- serious pulmonary diseases
- motional resriction (e.g. amputee)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medical Clinic I, University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: Pilot Study for Evaluation of the MeDiNa Concept of Homely Rehabilitation of Patients With Acute Myocardial Infarction
In this study feasibility of the MeDiNa concept is looked at, which means telemedical services for homely rehabilitation. With the help of microsystems technology, the relevant vital signs are measured at the patient's home, then transmitted to the MeDiNa- Homebox- Tablet PC (by bluetooth) and then transferred into a central database, the MeDiNa eHealth- portal (by HSDPA, UMTS). These parameters can be continuously monitored by authorized network participants such as the family doctor or the patients themselves. In future, beyond cost advantages this will help to supervise risk patients or inspire patients to take more care of their health during homely rehab.
Read the detailed description
Patients after myocard infarction who undergo homely rehab post stationary are divided into two groups of 10 patients each. The patients of group A undergo home monitoring for 4 weeks with the MeDiNa Homebox and afterwards 4 weeks without home monitoring. Group B starts vice versa, without home monitoring first and then undergoes home monitoring for 4 weeks (cross over,controlled intra-individually). During home monitoring with the MeDiNa Homebox patients measure vital parameters (weight, blood pressure, ECG (by chest strap including micro sensors), pulse and activity (also by chest strap including accelerometer) several times a day. The pseudonomized data which are transferred via the MeDiNa Homebox- Tablet PC to the MeDiNa eHealth Internet Portal (UMTS, HSDPA) to which the responsible authorized medicines will have access will be evaluated descriptively.
- Conditions
- Feasibility of Telemedical Home Monitoring, Post Stationary, Patients With Myocardial Infarction
- Keywords
- feasibility, compliance, telemedical home monitoring, post stationary rehabilitation, patients with myocardial infarction
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | 10 patients who undergo home monitoring with the MeDiNa Homebox for 4 weeks and then 4 weeks without the MeDina Homebox | |
| Group B | Group B starts without the MeDiNa Homebox for 4 weeks and then undergo Homemonitoring with the MeDiNa Homebox for 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of feasibility of telemedical home monitoring with the MeDiNa concept with patients after myocard infarction post stationary who undergo homely rehab
Patients are divided into two groups of 10 patients.The patients of group A undergo home monitoring for 4 weeks with the MeDiNa Homebox and afterwards 4 weeks without home monitoring. Group B starts vice versa (cross over, controlled intra-individually). During home monitoring with the MeDiNa Homebox patients measure vital parameters (weight, blood pressure, pulse, ECG) several times a day. The data are sent to the MeDiNa Homebox (by Bluetooth) and then to an Internet Portal (by USMB, HSDPA), to which the responsible authorized medicine will have access.
Measured: 8 weeks for each patient, about 6 months totally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startSep 2011
- Primary completionApr 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feasibility of Telemedical Home MonitoringStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare, MUL Services GmbH, Fraunhofer Institute (IMS)
- Responsible party
- Sponsor
- Investigators
- Stefan Krüger, PD Dr. med., Principal investigator, RWTH Aachen University, Department of Cardiology, Pulmonology and Vascular Medecine Aachen, NRW, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175057
- Sponsor's protocol ID
- Medina Pilot Study
- Status last verified
- Mar 2013
- First submitted
- 2 Aug 2010
- Last updated
- 22 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Evaluation of the MeDiNa Concept of Homely Rehabilitation of Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01175057
- Acronym / sponsor ID
- Medina Pilot Study
- Conditions
- Feasibility of Telemedical Home Monitoring, Post Stationary, Patients With Myocardial Infarction
- Keywords
- feasibility, compliance, telemedical home monitoring, post stationary rehabilitation, patients with myocardial infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Philips Healthcare, MUL Services GmbH, Fraunhofer Institute (IMS)
- Study start
- Sep 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 4 Aug 2010 (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 feasibility of the MeDiNa concept is looked at, which means telemedical services for homely rehabilitation. With the help of microsystems technology, the relevant vital signs are measured at the patient's home, then transmitted to the MeDiNa- Homebox- Tablet PC (by bluetooth) and then transferred into a central database, the MeDiNa eHealth- portal (by HSDPA, UMTS). These parameters can be continuously monitored by authorized network participants such as the family doctor or the patients themselves. In future, beyond cost advantages this will help to supervise risk patients or inspire patients to take more care of their health during homely rehab.
Detailed description
Patients after myocard infarction who undergo homely rehab post stationary are divided into two groups of 10 patients each. The patients of group A undergo home monitoring for 4 weeks with the MeDiNa Homebox and afterwards 4 weeks without home monitoring. Group B starts vice versa, without home monitoring first and then undergoes home monitoring for 4 weeks (cross over,controlled intra-individually). During home monitoring with the MeDiNa Homebox patients measure vital parameters (weight, blood pressure, ECG (by chest strap including micro sensors), pulse and activity (also by chest strap including accelerometer) several times a day. The pseudonomized data which are transferred via the MeDiNa Homebox- Tablet PC to the MeDiNa eHealth Internet Portal (UMTS, HSDPA) to which the responsible authorized medicines will have access will be evaluated descriptively.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –10 patients who undergo home monitoring with the MeDiNa Homebox for 4 weeks and then 4 weeks without the MeDina Homebox |
| Group B | – | –Group B starts without the MeDiNa Homebox for 4 weeks and then undergo Homemonitoring with the MeDiNa Homebox for 4 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the Medical Clinic I, RWTH Aachen University Hospital, Pauwelsstaße 30, 52074 Aachen, post stationary after myocardial infarction and who are at least 60 years old
Key inclusion criteria (5 listed)
- female and male patients minimum 60 years old
- myocardial infarction
- post stationary rehabilitation at home
- Internet access or mobile phone reception possible
- able to give informed consent
Key exclusion criteria (4 listed)
- patients with dementia
- aphasic impairment
- serious pulmonary diseases
- motional resriction (e.g. amputee)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of feasibility of telemedical home monitoring with the MeDiNa concept with patients after myocard infarction post stationary who undergo homely rehab
Time frame: 8 weeks for each patient, about 6 months totally
Patients are divided into two groups of 10 patients.The patients of group A undergo home monitoring for 4 weeks with the MeDiNa Homebox and afterwards 4 weeks without home monitoring. Group B starts vice versa (cross over, controlled intra-individually). During home monitoring with the MeDiNa Homebox patients measure vital parameters (weight, blood pressure, pulse, ECG) several times a day. The data are sent to the MeDiNa Homebox (by Bluetooth) and then to an Internet Portal (by USMB, HSDPA), to which the responsible authorized medicine will have access.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
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.
Stefan Krüger, PD Dr. med. principal investigator
RWTH Aachen University, Department of Cardiology, Pulmonology and Vascular Medecine Aachen, NRW, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Feasibility of Telemedical Home Monitoring and Post Stationary, run by RWTH Aachen University at 1 site 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of feasibility of telemedical home monitoring with the MeDiNa concept with patients after myocard infarction post stationary who undergo homely rehab (time frame: 8 weeks for each patient, about 6 months totally). 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 22 Mar 2013.