Telecommunication Via Cell Phones During Post-Operative Treatment After Lung Transplantation (TeleTx)

July 19, 2011 updated by: Hannover Medical School

Telecommunication Via Cell Phones During Post-Operative Treatment After Lung Transplantation - an Open, Randomised Trial

In an investigation should be evaluated in contrast to a control group with standard post-treatment therapy (using home spirometry) after lung transplantation if transfer of home spirometry recordings to the transplant center via cell phones will lead to less complications, cost savings and bigger constancy of therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Home spirometry is used as a standard of care in lung transplant recipients in many centers worldwide. In case of deteriorating lung function response until therapy depends on patients efforts to reach the transplant center and the contactability of the transplant center.

Therefore transfer of home spirometry recordings to the transplant center via cell phones will lead to less complications, cost savings and bigger constancy of therapy compared to the home spirometry alone.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 3

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
      • Hannover, Germany, 30625
        • Hannover Medical School, Dpt. resiratory Medicine OE6870

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients after lung transplantation (single and double lung transplantation incl. combined organ transplantation) before hospital discharge

Exclusion Criteria:

  • Dependency on long term care
  • Restricted ability to communicate

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
home spirometry alone
Device: Home spirometer w/o BT
Standard home spirometry
Other Names:
  • Viasys (Jaeger, Germany) AM1
Experimental: B
Home spirometry with data transfer via cellphone to clinical database
Device: Home spirometry with data transfer via cell phone
home spirometry recording
Other Names:
  • Viasys AM1 /group A
  • Viasys AM1+BT/ group B
Device: Home spirometer with BT-cellphone
Data transfer of home spirometry recordings via bluetooth to clinical database.
Other Names:
  • Viasys AM1 BT (Jaeger, Germany) with BT-cellphone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adherence
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Latency: symptom onset to transplant team contact patient contacts emergency visits hospitalisations
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Hannover Medical School

Collaborators

Corscience, Inc.

Investigators

  • Principal Investigator: Jens Gottlieb, MD, Dpt. Respiratory Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

September 27, 2007

First Submitted That Met QC Criteria

September 27, 2007

First Posted (Estimate)

September 28, 2007

Study Record Updates

Last Update Posted (Estimate)

July 20, 2011

Last Update Submitted That Met QC Criteria

July 19, 2011

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 124

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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