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NCT Number: NCT01175057

MeDiNa Pilot Study for Evaluation of the MeDiNa Concept of Homely Rehabilitation After 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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Clinic I, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Collaborators

  • Fraunhofer Institute (IMS)
  • MUL Services GmbH
  • Philips Healthcare

Registry information

Official study title

Pilot Study for Evaluation of the MeDiNa Concept of Homely Rehabilitation of Patients With Acute Myocardial Infarction

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 4, 2010
Registry last updated
Mar 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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