MeDiNa Pilot Study for Evaluation of the MeDiNa Concept of Homely Rehabilitation After Myocardial Infarction

This study has been completed.
Sponsor:
Collaborators:
Philips Healthcare
MUL Services GmbH
Fraunhofer Institute (IMS)
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01175057
First received: August 2, 2010
Last updated: March 21, 2013
Last verified: March 2013

August 2, 2010
March 21, 2013
September 2011
April 2012   (final data collection date for 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 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01175057 on ClinicalTrials.gov Archive Site
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MeDiNa Pilot Study for Evaluation of the MeDiNa Concept of Homely Rehabilitation After Myocardial Infarction
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Non-Probability Sample

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

  • Feasibility of Telemedical Home Monitoring
  • Post Stationary
  • Patients With Myocardial Infarction
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  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
September 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • patients with dementia
  • aphasic impairment
  • serious pulmonary diseases
  • motional resriction (e.g. amputee)
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01175057
Medina Pilot Study
No
RWTH Aachen University
RWTH Aachen University
  • Philips Healthcare
  • MUL Services GmbH
  • Fraunhofer Institute (IMS)
Principal Investigator: Stefan Krüger, PD Dr. med. RWTH Aachen University, Department of Cardiology, Pulmonology and Vascular Medecine Aachen, NRW, Germany
RWTH Aachen University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP