Telecommunication Via Cell Phones During Post-Operative Treatment After Lung Transplantation - Full Text View

Sponsors and Collaborators:	Hannover Medical School Corscience Inc, Germany
Information provided by:	Hannover Medical School
ClinicalTrials.gov Identifier:	NCT00536926

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 Viasys AM1 BT with BT-cellphone Device: Home spirometer w/o BT	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Telecommunication Via Cell Phones During Post-Operative Treatment After Lung Transplantation - an Open, Randomised Trial

Resource links provided by NLM:

MedlinePlus related topics: Lung Transplantation

U.S. FDA Resources

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 ]

Estimated Enrollment:	56
Study Start Date:	July 2007
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator home spirometry alone	Device: Home spirometer w/o BT Standard home spirometry
B: Experimental Homespirometry with data transfer via cellphone to clinical database	Device: Home spirometry with data transfer via cell phone Viasys home spirometry recording Device: Home spirometer Viasys AM1 BT with BT-cellphone Data transfer of home spirometry recordings via bluetooth to clinical database.

Detailed Description:

Homespirometry 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 hoemspirometry 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 doublelung tx incl. combined organ tx) before hospital discharge

Exclusion Criteria:

Dependency on long term care
Restricted ability to communicate

Contacts and Locations

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

Contacts

Contact: Jens Gottlieb, MD	+49-511-532 ext 3560	gottlieb.jens@mh-hannover.de
Contact: Isabelle Bodmann	+49-511-532 ext 2667	bodmann.isabelle@mh-hannover.de

Locations

Germany
Hannover Medical School, Dpt. resiratory Medicine OE6870	Recruiting
Hannover, Germany, 30625
Contact: Isabelle Bodmann +49-511532 ext 2667 bodmann.isabelle@mh-hannover.de
Principal Investigator: Jens T Gottlieb, MD

Sponsors and Collaborators

Hannover Medical School

Corscience Inc, Germany

Investigators

Principal Investigator:

Jens Gottlieb, MD

Dpt. Respiratory Medicine

More Information

No publications provided

Responsible Party:	Hannover Medical School ( Jens Gottlieb, M.D. )
Study ID Numbers:	124
Study First Received:	September 27, 2007
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00536926 History of Changes
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 September 11, 2009