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Sponsors and Collaborators: |
Hannover Medical School Corscience Inc, Germany |
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Information provided by: | Hannover Medical School |
ClinicalTrials.gov Identifier: | NCT00536926 |
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 |
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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 |
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 |
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A: Active Comparator
home spirometry alone
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Device: Home spirometer w/o BT
Standard home spirometry
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B: Experimental
Homespirometry with data transfer via cellphone to clinical database
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Jens Gottlieb, MD | Dpt. Respiratory Medicine |
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 |
telemedicine lung transplantation home spirometry |