NCT00743171

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2008

Completed
Last Updated

August 29, 2008

Status Verified

August 1, 2008

Enrollment Period

7.9 years

First QC Date

August 26, 2008

Last Update Submit

August 27, 2008

Conditions

Lung TransplantationRejectionDeathBronchiolitis Obliterans

Keywords

Lung transplantationHome spirometrynon-adherenceoutcomesbronchiolitis obliterans

Outcome Measures

Primary Outcomes (1)

  • Graft loss

    3 year

Secondary Outcomes (3)

  • BOS

    3 year

  • Number of acute rejections

    3 year

  • Number of hospitalizations

    3 year

Study Arms (3)

1

Good adherent patient: patient performed ≥ 80% of predicted HS within 24 months

2

Moderate adherent patient: patient performed ≥ 50% of predicted HS within 24 months

3

Non-adherent patient: patient performed \< 50% of predicted HS within 24 months.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

lung transplant recipients surviving to outpatient follow-up \>6 months in Hannover Medical School

You may qualify if:

  • 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

You may not qualify if:

  • Refused consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

Location

Related Publications (5)

  • 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.

    PMID: 16015225BACKGROUND

  • 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.

    PMID: 18212623BACKGROUND

  • 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.

    PMID: 16160588BACKGROUND

  • 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.

    PMID: 9029392BACKGROUND

  • 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.

    PMID: 8390943BACKGROUND

MeSH Terms

Conditions

Rejection, PsychologyDeathBronchiolitis Obliterans

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorPathologic ProcessesPathological Conditions, Signs and SymptomsBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Jens T Gottlieb, MD

    Dpt. Pneumology

    PRINCIPAL INVESTIGATOR

  • Christiane Kugler, MSc

    Dpt. Cardiothoracic, Transplantation and Vascular Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 26, 2008

First Posted

August 28, 2008

Study Start

January 1, 2000

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

August 29, 2008

Record last verified: 2008-08

Locations

DE(1)