NCT00536926

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2007

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

July 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

July 20, 2011

Status Verified

October 1, 2008

Enrollment Period

1.3 years

First QC Date

September 27, 2007

Last Update Submit

July 19, 2011

Conditions

Lung Transplantation

Keywords

telemedicinelung transplantationhome spirometry

Outcome Measures

Primary Outcomes (1)

  • Adherence

    6 months

Secondary Outcomes (1)

  • Latency: symptom onset to transplant team contact patient contacts emergency visits hospitalisations

    6 months

Study Arms (2)

A

ACTIVE COMPARATOR

home spirometry alone

Device: Home spirometer w/o BT

B

EXPERIMENTAL

Home spirometry with data transfer via cellphone to clinical database

Device: Home spirometry with data transfer via cell phoneDevice: Home spirometer with BT-cellphone

Interventions

Home spirometry with data transfer via cell phoneDEVICE

home spirometry recording

Also known as: Viasys AM1 /group A, Viasys AM1+BT/ group B
B
Home spirometer with BT-cellphoneDEVICE

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

Also known as: Viasys AM1 BT (Jaeger, Germany) with BT-cellphone
B
Home spirometer w/o BTDEVICE

Standard home spirometry

Also known as: Viasys (Jaeger, Germany) AM1
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients after lung transplantation (single and double lung transplantation incl. combined organ transplantation) before hospital discharge

You may not qualify if:

  • Dependency on long term care
  • Restricted ability to communicate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School, Dpt. resiratory Medicine OE6870

Hanover, 30625, Germany

Location

Related Publications (1)

  • 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.

    PMID: 21265282RESULT

Study Officials

  • Jens Gottlieb, MD

    Dpt. Respiratory Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 27, 2007

First Posted

September 28, 2007

Study Start

July 1, 2007

Primary Completion

November 1, 2008

Study Completion

July 1, 2009

Last Updated

July 20, 2011

Record last verified: 2008-10

Locations

DE(1)