Lung TransplantationPhase 2NCT01398488
Patient Education After Lung Transplantation Via Tablet Computers Versus Conventional Education
A Phase 2 study testing Patient education in people with Lung Transplantation, run by Hannover Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- Patient education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to May 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Education After Lung Transplantation Via Tablet Computers Versus Conventional Education - a Randomized Open Controlled Trial
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.
Read the detailed description
Noncompliance with immunosuppressive medications after organ transplantation is thought to be a leading cause of allograft rejection, graft loss, and death. Immunosuppressant medy to prevent graft rejection after lung transplantation.
Reported non-compliance rates with calcineurin inhibitors are ranging between 13 and 22 % after lung transplantation. Incidence of non-compliance increases over time after transplantation. Increased health care costs, decreased quality of life, and organ failure (incl. the need for re-do transplantation) are possible consequences of immunosuppressant noncompliance. Therefore, medication compliance defined as the extent to which a patient's medication taking behaviour coincides with the prescribed regimen, is a critical issue in transplantation. Repeated patient education is one option to overcome non-adherence and immunosuppressive medication non-compliance.
Immunosuppressive therapy is monitored by measurement of drug levels. Fluctuating drug levels increase the risk for rejection and drug toxicities. In addition, frequent dose adjustments, case management and frequent monitoring of drug levels are cost-intensive.
- Conditions
- Lung Transplantation
- Being tested
- Patient education
- Keywords
- Trough levels, Education, Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient educationBehavioural
Patient education by health care professional compared to education via tablet PC
| Study group | Role | What they receive |
|---|---|---|
| Conventional Patient education | Active comparator | Conventional Patient education by health care professionals. Receives: 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. Receives: Behavioral: Patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 month
Secondary outcomes (9)
Calcineurin trough levels variability
Trough level variability 6 months after patient education compared to 6 months before patient education
Measured: 6 month
Interval Adherence
interval adherence (number of measurements vs. recommended measurements) 6 months after patient education compared to 6 months before patient education
Measured: 6 month
Trough level interval
Interval of trough level measurement variability 6 months after patient education compared to 6 months before patient education
Measured: 6 month
Total time of education
Total time of education
Measured: 6 month
Total time of answering questionnaire
Total time of answering questionnaire
Measured: 6 month
Knowledge Improvement
Improvement of patient knowledge on immunosuppressive after patient education
Measured: 6 month
Self rated adherence
Self rated adherence to immunosuppressive medication (BAASIS scale)
Measured: 6 month
Adherence
Therapy adherence 6 months after patient education compared to 6 months before patient education
Measured: 6 month
Glomerular filtration rate
Glomerular filtration rate 6 months after patient education compared to baseline (CKD-EPI)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Fuehner, Hannover Medical School
- Investigators
- Jens T Gottlieb, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398488
- Sponsor's protocol ID
- V 2.0 16/03/2011
- Status last verified
- Jun 2013
- First submitted
- 5 Jul 2011
- Last updated
- 6 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36094829Suhling 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.
PubMed 24608864
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Education After Lung Transplantation Via Tablet Computers Versus Conventional Education - a Randomized Open Controlled Trial
- ClinicalTrials.gov ID
- NCT01398488
- Acronym / sponsor ID
- V 2.0 16/03/2011
- Conditions
- Lung Transplantation
- Keywords
- Trough levels, Education, Adherence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Noncompliance with immunosuppressive medications after organ transplantation is thought to be a leading cause of allograft rejection, graft loss, and death. Immunosuppressant medy to prevent graft rejection after lung transplantation.
Reported non-compliance rates with calcineurin inhibitors are ranging between 13 and 22 % after lung transplantation. Incidence of non-compliance increases over time after transplantation. Increased health care costs, decreased quality of life, and organ failure (incl. the need for re-do transplantation) are possible consequences of immunosuppressant noncompliance. Therefore, medication compliance defined as the extent to which a patient's medication taking behaviour coincides with the prescribed regimen, is a critical issue in transplantation. Repeated patient education is one option to overcome non-adherence and immunosuppressive medication non-compliance.
Immunosuppressive therapy is monitored by measurement of drug levels. Fluctuating drug levels increase the risk for rejection and drug toxicities. In addition, frequent dose adjustments, case management and frequent monitoring of drug levels are cost-intensive.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Patient education | Active comparator | Behavioral: Patient educationConventional Patient education by health care professionals. |
| Patient education via Tablet computer | Experimental | Behavioral: Patient educationPatient education after lung transplantation via Tablet computers. An electronic patient questionnaire via tablet computer will be collected in addition. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient educationPatient education by health care professional compared to education via tablet PC | Behavioural | Conventional Patient education, Patient education via Tablet computer |
Primary outcome
Calcineurin trough levels
Time frame: 6 month
Improvement of percentage of calcineurin inhibitor trough levels (Delta %) in target range 6 months after patient education compared to 6 months before patient education
9 secondary outcomes
Calcineurin trough levels variability
Time frame: 6 month
Interval Adherence
Time frame: 6 month
Trough level interval
Time frame: 6 month
Total time of education
Time frame: 6 month
Total time of answering questionnaire
Time frame: 6 month
Knowledge Improvement
Time frame: 6 month
Self rated adherence
Time frame: 6 month
Adherence
Time frame: 6 month
Glomerular filtration rate
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2013.
- Derived from this study: PubMed 36094829Mellon 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.
- Derived from this study: PubMed 24608864Suhling 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens T Gottlieb, MD principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Patient education in people with Lung Transplantation, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calcineurin trough levels (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01398488, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2013.