Long-Term Study On Home Spirometry After Lung Transplantation
NCT ID: NCT00743171
Last Updated: 2008-08-29
Study Results
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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COMPLETED
152 participants
OBSERVATIONAL
2000-01-31
2007-12-31
Brief Summary
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Detailed Description
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Patient will be stratified according to adherence to HS during the first 2 postoperative years Good adherent patient: patient performed ≥ 80% of predicted HS within 24 months Moderate adherent patient: patient performed ≥ 50% of predicted HS within 24 months Non-adherent patient: patient performed \< 50% of predicted HS within 24 months.
Primary outcome measure graft loss at end of follow-up
Secondary outcome measure number of acute rejections during follow-up number of hospitalisation during follow-up Incidence of bronchiolitis obliterans syndrome during follow-up
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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1
Good adherent patient: patient performed ≥ 80% of predicted HS within 24 months
No interventions assigned to this group
2
Moderate adherent patient: patient performed ≥ 50% of predicted HS within 24 months
No interventions assigned to this group
3
Non-adherent patient: patient performed \< 50% of predicted HS within 24 months.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* \> 18 years of age
* LTx or HLTx ≥ 6mts post Tx
* Stable health condition at study entry (pt stays within home environment)
* Sufficient language skills for AMOS training
* Successful AMOS training
* Follow-up at our center (≥6 mts post LTx)
* Willingness to participate by informed consent
Exclusion Criteria
* BOS diagnosis before study inclusion
* Malignancy before study inclusion
* Loss for follow-up (≤ 6 mts after study inclusion
18 Years
70 Years
ALL
No
Sponsors
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Hannover Medical School
OTHER
Responsible Party
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Hannover Medical School, Dpt. Pneumology
Principal Investigators
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Jens T Gottlieb, MD
Role: PRINCIPAL_INVESTIGATOR
Dpt. Pneumology
Christiane Kugler, MSc
Role: PRINCIPAL_INVESTIGATOR
Dpt. Cardiothoracic, Transplantation and Vascular Surgery
Locations
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Hannover Medical School
Hanover, , Germany
Countries
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References
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Finkelstein SM, Scudiero A, Lindgren B, Snyder M, Hertz MI. Decision support for the triage of lung transplant recipients on the basis of home-monitoring spirometry and symptom reporting. Heart Lung. 2005 May-Jun;34(3):201-8. doi: 10.1016/j.hrtlng.2004.09.003.
Dew MA, Dimartini AF, De Vito Dabbs A, Zomak R, De Geest S, Dobbels F, Myaskovsky L, Switzer GE, Unruh M, Steel JL, Kormos RL, McCurry KR. Adherence to the medical regimen during the first two years after lung transplantation. Transplantation. 2008 Jan 27;85(2):193-202. doi: 10.1097/TP.0b013e318160135f.
De Geest S, Dobbels F, Fluri C, Paris W, Troosters T. Adherence to the therapeutic regimen in heart, lung, and heart-lung transplant recipients. J Cardiovasc Nurs. 2005 Sep-Oct;20(5 Suppl):S88-98. doi: 10.1097/00005082-200509001-00010.
Finkelstein SM, Snyder M, Edin-Stibbe C, Chlan L, Prasad B, Dutta P, Lindgren B, Wielinski C, Hertz MI. Monitoring progress after lung transplantation from home-patient adherence. J Med Eng Technol. 1996 Nov-Dec;20(6):203-10. doi: 10.3109/03091909609008999.
Bjortuft O, Johansen B, Boe J, Foerster A, Holter E, Geiran O. Daily home spirometry facilitates early detection of rejection in single lung transplant recipients with emphysema. Eur Respir J. 1993 May;6(5):705-8.
Other Identifiers
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MHH 2008-3
Identifier Type: -
Identifier Source: org_study_id