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

NCT ID: NCT01175057

Last Updated: 2013-03-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 18 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-09-30

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group A

10 patients who undergo home monitoring with the MeDiNa Homebox for 4 weeks and then 4 weeks without the MeDina Homebox

No interventions assigned to this group

Group B

Group B starts without the MeDiNa Homebox for 4 weeks and then undergo Homemonitoring with the MeDiNa Homebox for 4 weeks.

No interventions assigned to this group

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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Healthcare

INDUSTRY

Sponsor Role: collaborator

MUL Services GmbH

UNKNOWN

Sponsor Role: collaborator

Fraunhofer Institute (IMS)

UNKNOWN

Sponsor Role: collaborator

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Krüger, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

RWTH Aachen University, Department of Cardiology, Pulmonology and Vascular Medecine Aachen, NRW, Germany

Locations

Medical Clinic I, University Hospital Aachen

Aachen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

Medina Pilot Study

Identifier Type: -

Identifier Source: org_study_id