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
  Purpose

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.


Condition
Feasibility of Telemedical Home Monitoring
Post Stationary
Patients With Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Pilot Study for Evaluation of the MeDiNa Concept of Homely Rehabilitation of Patients With Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • 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.


Enrollment: 18
Study Start Date: September 2011
Study Completion Date: September 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175057

Locations
Germany
Medical Clinic I, University Hospital Aachen
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Philips Healthcare
MUL Services GmbH
Fraunhofer Institute (IMS)
Investigators
Principal Investigator: Stefan Krüger, PD Dr. med. RWTH Aachen University, Department of Cardiology, Pulmonology and Vascular Medecine Aachen, NRW, Germany
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01175057     History of Changes
Other Study ID Numbers: Medina Pilot Study
Study First Received: August 2, 2010
Last Updated: March 21, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
feasibility
compliance
telemedical home monitoring
post stationary rehabilitation
patients with myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014