Lung TransplantationPhase 3TeleTxNCT00536926
Telecommunication Via Cell Phones During Post-Operative Treatment After Lung Transplantation
A Phase 3 study testing Home spirometry with data transfer via cell phone, Home spirometer with BT-cellphone and Home spirometer w/o BT in people with Lung Transplantation, run by Hannover Medical School at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- Home spirometry with data transfer via cell phone, Home spirometer with BT-cellphone and Home spirometer w/o BT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2007to Jul 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients after lung transplantation (single and double lung transplantation incl. combined organ transplantation) before hospital discharge
Who cannot join
- Dependency on long term care
- Restricted ability to communicate
Trial locations and contacts
1 site in 1 country.
Germany1 site
Hannover Medical School, Dpt. resiratory Medicine OE6870
Hanover, 30625
About this study
Official title: Telecommunication Via Cell Phones During Post-Operative Treatment After Lung Transplantation - an Open, Randomised Trial
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.
Read the detailed 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.
- Conditions
- Lung Transplantation
- Being tested
- Home spirometry with data transfer via cell phone, Home spirometer with BT-cellphone, Home spirometer w/o BT
- Keywords
- telemedicine, lung transplantation, home spirometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home spirometry with data transfer via cell phoneDevice
Also called Viasys AM1 /group A, Viasys AM1+BT/ group B
home spirometry recording
Home spirometer with BT-cellphoneDevice
Also called Viasys AM1 BT (Jaeger, Germany) with BT-cellphone
Data transfer of home spirometry recordings via bluetooth to clinical database.
Home spirometer w/o BTDevice
Also called Viasys (Jaeger, Germany) AM1
Standard home spirometry
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | home spirometry alone Receives: Device: Home spirometer w/o BT |
| B | Experimental | Home spirometry with data transfer via cellphone to clinical database Receives: Device: Home spirometry with data transfer via cell phone; Device: Home spirometer with BT-cellphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Measured: 6 months
Secondary outcomes (1)
Latency: symptom onset to transplant team contact patient contacts emergency visits hospitalisations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2007 (estimated)
- Study startJul 2007
- Primary completionNov 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Corscience, Inc.
- Investigators
- Jens Gottlieb, MD, Principal investigator, Dpt. Respiratory Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536926
- Sponsor's protocol ID
- 124
- Acronym
- TeleTx
- Status last verified
- Oct 2008
- First submitted
- 27 Sep 2007
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21265282
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telecommunication Via Cell Phones During Post-Operative Treatment After Lung Transplantation - an Open, Randomised Trial
- ClinicalTrials.gov ID
- NCT00536926
- Acronym / sponsor ID
- TeleTx / 124
- Conditions
- Lung Transplantation
- Keywords
- telemedicine, lung transplantation, home spirometry
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Corscience, Inc.
- Study start
- Jul 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 28 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: Home spirometer w/o BThome spirometry alone |
| B | Experimental | Device: Home spirometry with data transfer via cell phone, Device: Home spirometer with BT-cellphoneHome spirometry with data transfer via cellphone to clinical database |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients after lung transplantation (single and double lung transplantation incl. combined organ transplantation) before hospital discharge
Key exclusion criteria (2 listed)
- Dependency on long term care
- Restricted ability to communicate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home spirometry with data transfer via cell phoneAlso: Viasys AM1 /group A, Viasys AM1+BT/ group Bhome spirometry recording | Device | B |
| Home spirometer with BT-cellphoneAlso: Viasys AM1 BT (Jaeger, Germany) with BT-cellphoneData transfer of home spirometry recordings via bluetooth to clinical database. | Device | B |
| Home spirometer w/o BTAlso: Viasys (Jaeger, Germany) AM1Standard home spirometry | Device | A |
Primary outcome
Adherence
Time frame: 6 months
1 secondary outcome
Latency: symptom onset to transplant team contact patient contacts emergency visits hospitalisations
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
- Results publication: PubMed 21265282Sengpiel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Gottlieb, MD principal investigator
Dpt. Respiratory Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Home spirometry with data transfer via cell phone, Home spirometer with BT-cellphone and Home spirometer w/o BT in people with Lung Transplantation, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00536926, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2011.