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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lung Transplantation

Intervention / Treatment
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* Device: Home spirometry with data transfer via cell phone
* Device: Home spirometer with BT-cellphone
* Device: Home spirometer w/o BT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence |  | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemedicine, lung transplantation, home spirometry