Adherence Intervention Post TransplantationISALKNCT04207125
Improving ImmunoSuppression Adherence After Liver or Kidney Transplantation
A study testing Multilevel psychotherapeutic intervention programme in people with Adherence Intervention Post Transplantation, run by Medical University of Graz at 1 site in Austria.
Trial summary
Indication: liver (LT) or kidney Transplantation (KT) Objectives: to measure medication adherence in liver or kidney transplant patients with and without multilevel intervention programme over time Trial Design: prospective, single-centre, randomized controlled study Population: patients (male/female/diverse) between… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Adherence Intervention Post Transplantation
- What is being tested?
- Multilevel psychotherapeutic intervention programme
- 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 siteAustria
- Study dates
- 11 Mar 2020to 7 Sep 2021
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (male/female) listed for LT and KT
- Ability of subject to understand character and individual consequences of the trial
- Fluent in speaking the German language
- Written informed consent must be available before enrolment in the trial
- Basis immunosuppression with Tacrolimus
Who cannot join
- Patients < 18 or > 90 years
- Pregnant or lactating women
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Nadja Fink, BSc contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz, Klin. Abteilung für Transplantationschirurgie
Graz, 8036
Judith Kahn, MD
About this study
Official title: Improving ImmunoSuppression Adherence After Liver or Kidney Transplantation -a Randomized Controlled Single Centre Trial
Indication: liver (LT) or kidney Transplantation (KT)
Objectives: to measure medication adherence in liver or kidney transplant patients with and without multilevel intervention programme over time
Read more
Trial Design: prospective, single-centre, randomized controlled study
Population: patients (male/female/diverse) between 18 and 90 years of age scheduled for LT or KT
Sample Size:
75 control patients (standard of care) 75 patients in treatment group (participation in multilevel intervention programme)
Statistical Analysis: The data will be analysed descriptively; continuous variables will be summarized using mean ± SD (standard deviation) or median, minimum and maximum and categorical data will be summarized using absolute and relative frequencies. For the primary outcome (Adherence to the immunosuppressive regime measured by BAASIS) and further categorical variables, differences between the groups will be assessed by the Pearson Chi-square test or Fisher's exact test. Group differences for continuous parameters will be assessed by the two-sample T-test or Mann-Whitney-U-test as appropriate.
Trial Duration and Dates: November 2019-October 2021
Read the detailed description
Organ transplantation is the best option for patients with chronic organ failure. After kidney (KT) or liver transplantations (LT), immunosuppressive medications have to be taken to avoid rejection. Lifelong adherence, the extent to which the patients behaviour matches the agreed upon prescribers recommendations, to immunosuppressive drugs is important to prevent graft failure (Pabst et al., 2015). The consequent immunosuppression intake and regular physician visits are important factors for a long transplant survival (Nöhre et al., 2018).
A high rate of immunosuppressive medication non-adherence and its impact on post-transplant graft function indicate a need for adherence enhancing interventions (De Bleser et al., 2011).
Non-adherence is linked to poor post-transplant outcomes including late acute rejection and graft loss (De Geest S. et al 2011; Dew MA et al 2008). Dew et al. concluded from a meta- analysis of 147 transplantation studies that nonadherence in renal allograft recipients was highest among solid organ transplant recipients, reaching 36 cases per 100 patients per year (Dew et al., 2007). Detection of adherence can be obtained by objective direct measures (observation that medication was taken) or indirect and subjective measures like self-reporting. The indirect measures include serum drug levels, biological markers and electronic monitoring. Adherence is a dynamic process with the need to be repetitive over time. The monitoring should be incorporated into the routine clinical management of all organ recipients. A recent study showed that combining self-reporting, assay and clinicians report yielded the highest sensitivity (72%) and specificity (42%) when compared to electronic monitoring (Low et al., 2019). Some new evidence suggest that moving from twice-daily to once-daily dosing of the immunosuppressive regimen, the calcineurin inhibitor, show indifferent prevalence rates with increased adherence or not improving the adherence (Lehner et al., 2018; Fellström et al., 2018).The aim of our study is to test the efficacy of such a multilevel education and psychosomatic intervention programme for improving medication adherence in patients after LT or KT.
- Primary Objective and Primary Endpoint The primary endpoint is the assessment of patient adherence using a validated version of the Basel Assessment of Adherence to Immunosuppressive Medication Scale (BAASIS) questionnaire.
- Secondary Objectives and Secondary Endpoints Secondary endpoints include the influence of the multilevel intervention programme on the coefficient of variation (CV%) of Tacrolimus (TAC), clinical outcomes including incidence of infections, acute rejection, liver and kidney values, death, graft loss, hospital readmission during the study period, side effects, number of trough level controls necessary during first 6 months, and achievement of TAC target concentrations.
- Being tested
- Multilevel psychotherapeutic intervention programme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multilevel psychotherapeutic intervention programmeBehavioural
Also called education training
Part 1: Educational Training and Mentoring After transferring the patient from the intensive care unit to the transplant surgery unit, nurses are planning a nursing diagnosis called "therapy recommendations and coping strategies, effective implementation". 3 days after the transfer, nurses start to give information twice a day (morning and evening) about the medication, which the patients are currently taking. The nurse is also handing out a folder, which contains information about the multilevel intervention programme.
Individual Treatment Approach Patients, who seem to be non-adherent during their outpatient follow-ups, are contacted through the co-investigators for a one-to-one session. The content of this session is to promote patients engagement in self-management of their chronic illness. The goal of the treatment is to improve the individual's ability to manage symptoms, treatments, physical and psychosocial consequences and lifestyle changes.
| Study group | Role | What they receive |
|---|---|---|
| Without multilevel intervention | No intervention | patients after liver or kidney transplantation / standard care |
| With multilevel intervention | Active comparator | patients after liver or kidney transplantation / multilevel intervention program Receives: Behavioral: Multilevel psychotherapeutic intervention programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-rating of adherence
Basler Assessment of Adherence to Immunosuppressive Medication Scale (BAASIS) The Basler assessment was developed to assess adherence to immunosuppressive drugs in adult transplant recipients. It follows the newly published taxonomy of medication adherence. This self-reported interview consists of three quantifiable phases: initiation, implementation and persistence. Five Items assess the implementation dimension and one assesses the persistence. An optional item assesses initiation. Responses to four questions are given on a 6-point scale ranging from zero (never) to five (every day) (Dobbels et al., 2010).
Measured: 6 months
Secondary outcomes (5)
Coefficient of Variation (CV%) of Tacrolimus
Measured: 6 months
Occurrence of infection episodes
Measured: 6 months
Occurrence of rejection episodes
Biopsy-proven acute rejection
Measured: 6 months
Rejection therapy
Administered rejection therapies
Measured: 6 months
Occurrence of side effects
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start11 Mar 2020
- Primary completion7 Sep 2021 (estimated)
- Study completion7 Sep 2021 (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 Adherence Intervention Post TransplantationStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Schemmer, Prof., Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207125
- Sponsor's protocol ID
- 32-062 ex 19/20
- Acronym
- ISALK
- Status last verified
- Nov 2020
- First submitted
- 20 Nov 2019
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wagner-Skacel J, Fink N, Kahn J, Dalkner N, Jauk E, Bengesser S, Mairinger M, Schussler G, Pieh C, Stadlbauer V, Kirsch AH, Zitta S, Rosenkranz AR, Fickert P, Schemmer P. Improving adherence to immunosuppression after liver or kidney transplantation in individuals with impairments in personality functioning - A randomized controlled single center feasibility study. Front Psychol. 2023 Mar 9;14:1150548. doi: 10.3389/fpsyg.2023.1150548. eCollection 2023.
PubMed 36968754
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving ImmunoSuppression Adherence After Liver or Kidney Transplantation -a Randomized Controlled Single Centre Trial
- ClinicalTrials.gov ID
- NCT04207125
- Acronym / sponsor ID
- ISALK / 32-062 ex 19/20
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 7 Sep 2021 (estimated)
- Study completion
- 7 Sep 2021 (estimated)
- First posted
- 20 Dec 2019 (actual)
- 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.
Indication: liver (LT) or kidney Transplantation (KT)
Objectives: to measure medication adherence in liver or kidney transplant patients with and without multilevel intervention programme over time
Trial Design: prospective, single-centre, randomized controlled study
Population: patients (male/female/diverse) between 18 and 90 years of age scheduled for LT or KT
Sample Size:
75 control patients (standard of care) 75 patients in treatment group (participation in multilevel intervention programme)
Statistical Analysis: The data will be analysed descriptively; continuous variables will be summarized using mean ± SD (standard deviation) or median, minimum and maximum and categorical data will be summarized using absolute and relative frequencies. For the primary outcome (Adherence to the immunosuppressive regime measured by BAASIS) and further categorical variables, differences between the groups will be assessed by the Pearson Chi-square test or Fisher's exact test. Group differences for continuous parameters will be assessed by the two-sample T-test or Mann-Whitney-U-test as appropriate.
Trial Duration and Dates: November 2019-October 2021
Detailed description
Organ transplantation is the best option for patients with chronic organ failure. After kidney (KT) or liver transplantations (LT), immunosuppressive medications have to be taken to avoid rejection. Lifelong adherence, the extent to which the patients behaviour matches the agreed upon prescribers recommendations, to immunosuppressive drugs is important to prevent graft failure (Pabst et al., 2015). The consequent immunosuppression intake and regular physician visits are important factors for a long transplant survival (Nöhre et al., 2018).
A high rate of immunosuppressive medication non-adherence and its impact on post-transplant graft function indicate a need for adherence enhancing interventions (De Bleser et al., 2011).
Non-adherence is linked to poor post-transplant outcomes including late acute rejection and graft loss (De Geest S. et al 2011; Dew MA et al 2008). Dew et al. concluded from a meta- analysis of 147 transplantation studies that nonadherence in renal allograft recipients was highest among solid organ transplant recipients, reaching 36 cases per 100 patients per year (Dew et al., 2007). Detection of adherence can be obtained by objective direct measures (observation that medication was taken) or indirect and subjective measures like self-reporting. The indirect measures include serum drug levels, biological markers and electronic monitoring. Adherence is a dynamic process with the need to be repetitive over time. The monitoring should be incorporated into the routine clinical management of all organ recipients. A recent study showed that combining self-reporting, assay and clinicians report yielded the highest sensitivity (72%) and specificity (42%) when compared to electronic monitoring (Low et al., 2019). Some new evidence suggest that moving from twice-daily to once-daily dosing of the immunosuppressive regimen, the calcineurin inhibitor, show indifferent prevalence rates with increased adherence or not improving the adherence (Lehner et al., 2018; Fellström et al., 2018).The aim of our study is to test the efficacy of such a multilevel education and psychosomatic intervention programme for improving medication adherence in patients after LT or KT.
- Primary Objective and Primary Endpoint The primary endpoint is the assessment of patient adherence using a validated version of the Basel Assessment of Adherence to Immunosuppressive Medication Scale (BAASIS) questionnaire.
- Secondary Objectives and Secondary Endpoints Secondary endpoints include the influence of the multilevel intervention programme on the coefficient of variation (CV%) of Tacrolimus (TAC), clinical outcomes including incidence of infections, acute rejection, liver and kidney values, death, graft loss, hospital readmission during the study period, side effects, number of trough level controls necessary during first 6 months, and achievement of TAC target concentrations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Without multilevel intervention | No intervention | –patients after liver or kidney transplantation / standard care |
| With multilevel intervention | Active comparator | Behavioral: Multilevel psychotherapeutic intervention programmepatients after liver or kidney transplantation / multilevel intervention program |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients (male/female) listed for LT and KT
- Ability of subject to understand character and individual consequences of the trial
- Fluent in speaking the German language
- Written informed consent must be available before enrolment in the trial
- Basis immunosuppression with Tacrolimus
Key exclusion criteria (3 listed)
- Patients < 18 or > 90 years
- Pregnant or lactating women
- Refusal to participate
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 |
|---|---|---|
| Multilevel psychotherapeutic intervention programmeAlso: education trainingPart 1: Educational Training and Mentoring After transferring the patient from the intensive care unit to the transplant surgery unit, nurses are planning a nursing diagnosis called "therapy recommendations and coping strategies, effective implementation". 3 days after the transfer, nurses start to give information twice a day (morning and evening) about the medication, which the patients are currently taking. The nurse is also handing out a folder, which contains information about the multilevel intervention programme. Individual Treatment Approach Patients, who seem to be non-adherent during their outpatient follow-ups, are contacted through the co-investigators for a one-to-one session. The content of this session is to promote patients engagement in self-management of their chronic illness. The goal of the treatment is to improve the individual's ability to manage symptoms, treatments, physical and psychosocial consequences and lifestyle changes. | Behavioural | With multilevel intervention |
Primary outcome
self-rating of adherence
Time frame: 6 months
Basler Assessment of Adherence to Immunosuppressive Medication Scale (BAASIS) The Basler assessment was developed to assess adherence to immunosuppressive drugs in adult transplant recipients. It follows the newly published taxonomy of medication adherence. This self-reported interview consists of three quantifiable phases: initiation, implementation and persistence. Five Items assess the implementation dimension and one assesses the persistence. An optional item assesses initiation. Responses to four questions are given on a 6-point scale ranging from zero (never) to five (every day) (Dobbels et al., 2010).
5 secondary outcomes
Coefficient of Variation (CV%) of Tacrolimus
Time frame: 6 months
Occurrence of infection episodes
Time frame: 6 months
Occurrence of rejection episodes
Time frame: 6 months
Rejection therapy
Time frame: 6 months
Occurrence of side effects
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Derived from this study: PubMed 36968754Wagner-Skacel J, Fink N, Kahn J, Dalkner N, Jauk E, Bengesser S, Mairinger M, Schussler G, Pieh C, Stadlbauer V, Kirsch AH, Zitta S, Rosenkranz AR, Fickert P, Schemmer P. Improving adherence to immunosuppression after liver or kidney transplantation in individuals with impairments in personality functioning - A randomized controlled single center feasibility study. Front Psychol. 2023 Mar 9;14:1150548. doi: 10.3389/fpsyg.2023.1150548. eCollection 2023.
- Individual participant dataSharing planned: No
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.
Nadja Fink, BSc contact
Peter Schemmer, Prof. principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multilevel psychotherapeutic intervention programme in people with Adherence Intervention Post Transplantation, run by Medical University of Graz at 1 site in Austria.
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 3 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 20 Nov 2020. 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 Austria. 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 Jolana Wagner-Skacel, MD (004331638583036, jolana.wagner-skacel@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-rating of adherence (time frame: 6 months). 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 NCT04207125, 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 20 Nov 2020.