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

NCT ID: NCT00536926

Last Updated: 2011-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-07-31

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.

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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.

Conditions

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Lung Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

home spirometry alone

Group Type ACTIVE_COMPARATOR

Home spirometer w/o BT

Intervention Type DEVICE

Standard home spirometry

B

Home spirometry with data transfer via cellphone to clinical database

Group Type EXPERIMENTAL

Home spirometry with data transfer via cell phone

Intervention Type DEVICE

home spirometry recording

Home spirometer with BT-cellphone

Intervention Type DEVICE

Data transfer of home spirometry recordings via bluetooth to clinical database.

Interventions

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Home spirometry with data transfer via cell phone

home spirometry recording

Intervention Type DEVICE

Home spirometer with BT-cellphone

Data transfer of home spirometry recordings via bluetooth to clinical database.

Intervention Type DEVICE

Home spirometer w/o BT

Standard home spirometry

Intervention Type DEVICE

Other Intervention Names

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Viasys AM1 /group A Viasys AM1+BT/ group B Viasys AM1 BT (Jaeger, Germany) with BT-cellphone Viasys (Jaeger, Germany) AM1

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corscience, Inc.

INDUSTRY

Sponsor Role collaborator

Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Hannover Medical School

Principal Investigators

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Jens Gottlieb, MD

Role: PRINCIPAL_INVESTIGATOR

Dpt. Respiratory Medicine

Locations

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Hannover Medical School, Dpt. resiratory Medicine OE6870

Hanover, , Germany

Site Status

Countries

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Germany

References

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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. doi: 10.1177/152692481002000402.

Reference Type RESULT
PMID: 21265282 (View on PubMed)

Other Identifiers

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124

Identifier Type: -

Identifier Source: org_study_id

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