Clinical trial NCT00743171: Long-Term Study On Home Spirometry After Lung Transplantation
Official title: Long-Term Study On Home Spirometry After Lung Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplantation
Rejection
Death
Bronchiolitis Obliterans
Keywords: Lung transplantation
Home spirometry
non-adherence
outcomes
bronchiolitis obliterans
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2008-08-28
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: lung transplant recipients surviving to outpatient follow-up \>6 months in Hannover Medical School

Brief summary: Prospective cohort, mono-center study included electronic data of home spirometry (HS, lung function) of lung transplant recipients

Detailed description: Study period between 1/2/2000 and 31/12/2003 Follow-up until 31/12/2007

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

Eligibility criteria: Inclusion Criteria:

* Any type of lung transplant incl single, double, combined and re-do
* \> 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:

* Refused consent
* BOS diagnosis before study inclusion
* Malignancy before study inclusion
* Loss for follow-up (≤ 6 mts after study inclusion

Primary outcomes:
measure: Graft loss
timeFrame: 3 year
Secondary outcomes:
measure: BOS
timeFrame: 3 year
measure: Number of acute rejections
timeFrame: 3 year
measure: Number of hospitalizations
timeFrame: 3 year
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Dpt. Pneumology
name: Jens T Gottlieb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dpt. Cardiothoracic, Transplantation and Vascular Surgery
name: Christiane Kugler, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.