NCT01398488

Brief Summary

Experimental intervention: Patient education after lung transplantation via Tablet computers. An electronic patient questionnaire via tablet computer will be collected in addition. Control intervention: Conventional Patient education by health care professionals. A paper-based patient questionnaire will be provided.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2011

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, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

June 6, 2013

Status Verified

June 1, 2013

Enrollment Period

1 year

First QC Date

July 5, 2011

Last Update Submit

June 5, 2013

Conditions

Lung Transplantation

Keywords

Trough levelsEducationAdherence

Outcome Measures

Primary Outcomes (1)

  • Calcineurin trough levels

    Improvement of percentage of calcineurin inhibitor trough levels (Delta %) in target range 6 months after patient education compared to 6 months before patient education

    6 month

Secondary Outcomes (9)

  • Calcineurin trough levels variability

    6 month

  • Interval Adherence

    6 month

  • Trough level interval

    6 month

  • Total time of education

    6 month

  • Total time of answering questionnaire

    6 month

  • +4 more secondary outcomes

Study Arms (2)

Conventional Patient education

ACTIVE COMPARATOR

Conventional Patient education by health care professionals.

Behavioral: Patient education

Patient education via Tablet computer

EXPERIMENTAL

Patient education after lung transplantation via Tablet computers. An electronic patient questionnaire via tablet computer will be collected in addition.

Behavioral: Patient education

Interventions

Patient educationBEHAVIORAL

Patient education by health care professional compared to education via tablet PC

Conventional Patient educationPatient education via Tablet computer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients at least 6 months after lung transplantation (single, double or combined)
  • Informed consent
  • At least 10 trough levels analyzed in MHH reference lab in last 6 months
  • \< 50% of calcineurin inhibitor trough levels in target range in last 6 months in outpatient clinic

You may not qualify if:

  • Hospitalization during last 3 months
  • BOS stage 3 (FEV1 \< 50% baseline)
  • End stage kidney disease (GFR \<15 ml/min/1.73 m2 or renal replacement therapy)
  • Oxygen requirement at rest
  • Steroid pulse therapy (\>500 mg methylprednisolone per day) during the last 4 weeks
  • Illiteracy
  • Need for isolation (Colonization with multi. or pan resistant organisms, e.g. MRSA, B. cenocepacia)
  • limited German language skills or other reasons which might impair patient communication or computer handling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanover Medical School

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (2)

  • Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.

    PMID: 36094829DERIVED

  • Suhling H, Rademacher J, Zinowsky I, Fuge J, Greer M, Warnecke G, Smits JM, Bertram A, Haverich A, Welte T, Gottlieb J. Conventional vs. tablet computer-based patient education following lung transplantation--a randomized controlled trial. PLoS One. 2014 Mar 7;9(6):e90828. doi: 10.1371/journal.pone.0090828. eCollection 2014.

    PMID: 24608864DERIVED

MeSH Terms

Interventions

Patient Education as Topic

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jens T Gottlieb, MD

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 5, 2011

First Posted

July 20, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

May 1, 2013

Last Updated

June 6, 2013

Record last verified: 2013-06

Locations

DE(1)