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NCT00536926 Clinical Trial

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

Lung Transplantation Clinical Trial

— TeleTx  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00536926
Other study ID # 124
Secondary ID
Status Completed
Phase Phase 3
First received September 27, 2007
Last updated July 19, 2011
Start date July 2007
Est. completion date July 2009

Study information
Verified date October 2008
Source Hannover Medical School
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date July 2009
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• Home spirometry with data transfer via cell phone
home spirometry recording
• Home spirometer with BT-cellphone
Data transfer of home spirometry recordings via bluetooth to clinical database.
• Home spirometer w/o BT
Standard home spirometry

Locations
Country Name City State
Germany Hannover Medical School, Dpt. resiratory Medicine OE6870 Hannover

Sponsors (2)
Lead Sponsor Collaborator
Hannover Medical School Corscience, Inc.

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Sengpiel J, Fuehner T, Kugler C, Avsar M, Bodmann I, Boemke A, Simon A, Welte T, Gottlieb J. Use of telehealth technology for home spirometry after lung transplantation: a randomized controlled trial. Prog Transplant. 2010 Dec;20(4):310-7. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Adherence 6 months Yes
Secondary Latency: symptom onset to transplant team contact patient contacts emergency visits hospitalisations 6 months Yes
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