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

This study has been completed.
Sponsor:
Collaborator:
Corscience, Inc.
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00536926
First received: September 27, 2007
Last updated: July 19, 2011
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Lung Transplantation
Device: Home spirometry with data transfer via cell phone
Device: Home spirometer with BT-cellphone
Device: Home spirometer w/o BT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Telecommunication Via Cell Phones During Post-Operative Treatment After Lung Transplantation - an Open, Randomised Trial

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Adherence [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Latency: symptom onset to transplant team contact patient contacts emergency visits hospitalisations [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 56
Study Start Date: July 2007
Study Completion Date: July 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
home spirometry alone
Device: Home spirometer w/o BT
Standard home spirometry
Other Name: 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 Name: Viasys AM1 BT (Jaeger, Germany) with BT-cellphone

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536926

Locations
Germany
Hannover Medical School, Dpt. resiratory Medicine OE6870
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Corscience, Inc.
Investigators
Principal Investigator: Jens Gottlieb, MD Dpt. Respiratory Medicine
  More Information

Publications:
Responsible Party: Jens Gottlieb, M.D., Hannover Medical School
ClinicalTrials.gov Identifier: NCT00536926     History of Changes
Other Study ID Numbers: 124
Study First Received: September 27, 2007
Last Updated: July 19, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:
telemedicine
lung transplantation
home spirometry

ClinicalTrials.gov processed this record on August 28, 2014