Clinical trial NCT01175057: MeDiNa Pilot Study for Evaluation of the MeDiNa Concept of Homely Rehabilitation After Myocardial Infarction
Official title: Pilot Study for Evaluation of the MeDiNa Concept of Homely Rehabilitation of Patients With Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
name: MUL Services GmbH
name: Fraunhofer Institute (IMS)
First posted: 2010-08-04
Enrollment: 18
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

Brief 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 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.

Eligibility 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)

Primary outcomes:
measure: Evaluation of feasibility of telemedical home monitoring with the MeDiNa concept with patients after myocard infarction post stationary who undergo homely rehab
timeFrame: 8 weeks for each patient, about 6 months totally
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Medical Clinic I, University Hospital Aachen
state: NRW
Study officials:
affiliation: RWTH Aachen University, Department of Cardiology, Pulmonology and Vascular Medecine Aachen, NRW, Germany
name: Stefan Krüger, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: