Medication AdherenceNCT00843960
Medication Adherence Enhancement in Heart Transplant Recipients
A study testing behavioral adaptation and symptom management in people with Medication Adherence and Self Management, run by Hannover Medical School at 1 site in Germany.
Trial summary
Medication-related non-adherence increases the risk of rejections and associated graft loss after solid organ transplantation. A randomized controlled intervention will use adherence enhancing strategies out of a larger sample of 300 heart transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Medication Adherence, Self Management, Rejection
- What is being tested?
- behavioral adaptation and symptom management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2009to Dec 2013
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all eligible patients with follow-up at our outpatient clinic
- written informed consent
- sufficient German language skills to read and answer a battery of questionnaires
- > 18 years
- minimum 6 mts post HTX
Who cannot join
- illiteracy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery
Hanover, 30625
Christiane Kugler, PhD, ++49.511.532. ext. 6586, kugler.christiane@mh-hannover.de
Christoph Bara, MD
About this study
Official title: Medication Adherence Enhancement in Heart Transplant Recipients: a Randomized Clinical Trial
Medication-related non-adherence increases the risk of rejections and associated graft loss after solid organ transplantation. A randomized controlled intervention will use adherence enhancing strategies out of a larger sample of 300 heart transplant recipients. Non-Adherence will be assessed by patients' self-report and based on immunosuppression level. All non-adherent patients will be randomly designed to either intervention or control group. Multi-module interventions include patient education, electronic medication event monitoring, and a combined behavior and symptom management. Longitudinal follow-up is envisioned after initial intervention.
- Conditions
- Medication Adherence, Self Management, Rejection
- Being tested
- behavioral adaptation and symptom management
- Medical subject headings
- Medication Adherence, Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral adaptation and symptom managementBehavioural
behavioral adaptation and symptom management
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | intervention group Receives: Behavioral: behavioral adaptation and symptom management |
| 2 | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events (composite endpoint)
Measured: at month 60
Secondary outcomes (5)
Adherence behavior measurement variables from MEMS system
Measured: first 3 month
Immunosuppression level
Measured: Month 3, 12 and 60
All individual components of the composite endpoint occurence of adverse events
Measured: at month 60
Immunosuppression level
Measured: month 12
Immunosuppression level
Measured: at month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2010 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Investigators
- Christiane Kugler, PhD, Principal investigator, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843960
- Sponsor's protocol ID
- IFB-P46-377
- Status last verified
- Oct 2009
- First submitted
- 12 Feb 2009
- Last updated
- 7 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
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 36094829
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Adherence Enhancement in Heart Transplant Recipients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00843960
- Acronym / sponsor ID
- IFB-P46-377
- Conditions
- Medication Adherence, Self Management, Rejection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Feb 2009
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 13 Feb 2009 (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.
Medication-related non-adherence increases the risk of rejections and associated graft loss after solid organ transplantation. A randomized controlled intervention will use adherence enhancing strategies out of a larger sample of 300 heart transplant recipients. Non-Adherence will be assessed by patients' self-report and based on immunosuppression level. All non-adherent patients will be randomly designed to either intervention or control group. Multi-module interventions include patient education, electronic medication event monitoring, and a combined behavior and symptom management. Longitudinal follow-up is envisioned after initial intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: behavioral adaptation and symptom managementintervention group |
| 2 | No intervention | –control group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- all eligible patients with follow-up at our outpatient clinic
- written informed consent
- sufficient German language skills to read and answer a battery of questionnaires
- > 18 years
- minimum 6 mts post HTX
Key exclusion criteria (1 listed)
- illiteracy
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 |
|---|---|---|
| behavioral adaptation and symptom managementbehavioral adaptation and symptom management | Behavioural | 1 |
Primary outcome
Occurrence of adverse events (composite endpoint)
Time frame: at month 60
5 secondary outcomes
Adherence behavior measurement variables from MEMS system
Time frame: first 3 month
Immunosuppression level
Time frame: Month 3, 12 and 60
All individual components of the composite endpoint occurence of adverse events
Time frame: at month 60
Immunosuppression level
Time frame: month 12
Immunosuppression level
Time frame: at month 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2009.
- 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.
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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.
Christiane Kugler, PhD principal investigator
Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral adaptation and symptom management in people with Medication Adherence and Self Management, 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Oct 2009. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christiane Kugler, PhD (++49.511.532 ext. 6586, kugler.christiane@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse events (composite endpoint) (time frame: at month 60). 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 NCT00843960, which also lists 1 linked publication.
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 7 Oct 2009.