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

March 21, 2013 updated by: RWTH Aachen University

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Aachen, NRW, Germany, 52074
        • Medical Clinic I, University Hospital Aachen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks for each patient, about 6 months totally

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

August 2, 2010

First Submitted That Met QC Criteria

August 3, 2010

First Posted (ESTIMATE)

August 4, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 22, 2013

Last Update Submitted That Met QC Criteria

March 21, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Medina Pilot Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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