The Adherence of Immunosuppressive Therapy Including Tacrolimus Once-daily in Italian Kidney Transplant Recipients

Study Overview
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Brief Summary
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Non-adherence is widespread in the transplant community. Addressing issues associated with non-adherence remains a key challenge in transplantation, in part due to the difficulty in assessing its prevalence, as there is currently no 'gold standard' for use in routine clinical practice. The purpose of this study is to evaluate the non-adherence to immunosuppressive therapy, including tacrolimus once-daily, among Italian kidney transplant recipients receiving. Along with non-adherence evaluation, possible factors related to NA will be investigated (patient-related, condition/disease-related, therapy/treatment-related, etc.).

Official Title
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The Adherence of Immunosuppressive Therapy Including Tacrolimus Once Daily in a Cohort of Kidney Transplant Recipients: an Italian Prospective Observational Study

Conditions
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Kidney Transplant

Intervention / Treatment
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* Drug: Immunosuppressive


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Adult (≥ 18 years) recipients of a deceased- or living-donor kidney transplant since maximum 12 months. Recipients with a functioning graft Patients receiving tacrolimus once-daily as part of their IS therapy since minimum 2 months. Patients who have signed informed consent form and privacy form. Patients capable of discernment and able to read and write in Italian language. Exclusion criteria: Patients received or planned to receive, a non-renal solid organ transplant, a simultaneous pancreas-kidney transplant, or a bone narrow transplant. Patients who already received a kidney transplant (re-transplant). Patients enrolled or planned to be enrolled in any clinical study. Patients suffering from conditions and illnesses that might interfere with the study purpose, according to the investigator's evaluation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Immunosuppressive|Immunosuppressive therapies|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non aderence | Proportion of non-adherent patients to immunosuppressive therapy as measured by the Basel Assessment of Adherence with Immunosuppressives Scale (BAASIS©-interview). The BAASIS© consists of four items (with a 6-point scale for responses ranging from never (0) to every day (5)) measuring patients' taking, skipping (or drug holidays), timing (>2 hrs from prescribed time) and dose reduction of drugs. An affirmative answer to any of the first 4 questions results in assignment to the non-adherent group. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMQ score | Describe the patient's belief about immunosuppresive medicines, as measured by the Belief about Medicines Questionnaire (BMQ). It is an 18-item measure comprising of two subscales (general harm and general overuse), and two subscales (specific necessity and specific concerns). Higher scores in the General-Harm and General-Overuse sub-scales represent an overall negative perception of medication. High scores in the Specific-Concerns sub-scale means that adverse reactions are potentially harmful and high scores in the Specific-Necessity sub-scale are indicative of the patient's need to adhere to medication to maintain health. | Baseline and 6 months | 
| ACCEPT score | Describe the patient's acceptance toward immunosuppressive treatment, as measured by the ACCEPT questionnaire. It is a 32-items self-administered questionnaire and covers patient's opinion on: convenience of the medication, length of treatment, constraints due to medication, side effects and a general opinion on the medication. The score ranges from 0 (no acceptance) to 100 (maximum treatment acceptance). | Baseline and 6 months | 
| BAASIS evaluation | Perform the BAASIS assessement.The BAASIS consists of four items (with a 6-point scale for responses ranging from never (0) to every day (5)) measuring patients' taking, skipping (or drug holidays), timing (>2 hrs from prescribed time) and dose reduction of drugs. An affirmative answer to any of the first 4 questions results in assignment to the non-adherent group. | Baseline | 
| Patients characteristics | Describe patients characteristics (such as socio-demographics, lifestyle information, relevant comorbidities, concomitant medications, clinical characteristics information like e.g. primary kidney disease diagnosis, waiting time before graft, transplant characteristic e.g. type of donor, etc. | Baseline | 
| Clinical informations as for clinical practice | Collect clinical information (e.g. routine tacrolimus trough levels, eGFR if available) | Baseline and 6 months | 
| Immunosuppressive treatments | Immunosuppressive treatments description and changes | Baseline and 6 months | 
| Rejections | Occurrence of rejection episodes | Baseline and 6 months | 
| Graft failure | Occurrence of graf failure | Baseline and 6 months | 
| Adverse events | Number of adverse events | Baseline and 6 months | 
| Infections | Occurrence of infections | Baseline and 6 months | 
| Healthcare cost | Assess the healthcare cost (ER admission, hospitalizations) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adherence, tacrolimus, once-daily