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

Chiesi Farmaceutici S.p.A.158 enrolled

Overview

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.).

Study Type

OBSERVATIONAL

Enrollment

158

Conditions

Kidney Transplant

Interventions

ImmunosuppressiveDRUG

Immunosuppressive therapies

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Adult (≥ 18 years) recipients of a deceased- or living-donor kidney transplant since maximum 12 months. 2. Recipients with a functioning graft 3. Patients receiving tacrolimus once-daily as part of their IS therapy since minimum 2 months. 4. Patients who have signed informed consent form and privacy form. 5. Patients capable of discernment and able to read and write in Italian language. Exclusion criteria: 1. Patients received or planned to receive, a non-renal solid organ transplant, a simultaneous pancreas-kidney transplant, or a bone narrow transplant. 2. Patients who already received a kidney transplant (re-transplant). 3. Patients enrolled or planned to be enrolled in any clinical study. 4. Patients suffering from conditions and illnesses that might interfere with the study purpose, according to the investigator's evaluation.

Locations (12)

A.O.U. Consorziale Policlinico

Bari, Italy

A.O.U. Policlinico S.Orsola Malpighi

Bologna, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

A.O.U. Maggiore della Carità

Novara, Italy

Azienda Ospedaliera di Padova

Padova, Italy

ARNAS Ospedale Civico

Palermo, Italy

A.O.U. Pisana P.O. Cisanello

Pisa, Italy

Ospedale Cisanello

Pisa, Italy

Fondazione Policlinico Univ. Gemelli

Roma, Italy

A.O.U. Città della Salute e della Scienza

Torino, Italy

...and 2 more locations

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: Baseline

Clinical informations as for clinical practice

Collect clinical information (e.g. routine tacrolimus trough levels, eGFR if available)

Time frame: Baseline and 6 months

Immunosuppressive treatments

Immunosuppressive treatments description and changes

Time frame: Baseline and 6 months

Rejections

Occurrence of rejection episodes

Time frame: Baseline and 6 months

Graft failure

Occurrence of graf failure

Time frame: Baseline and 6 months

Adverse events

Number of adverse events

Time frame: Baseline and 6 months

Infections

Occurrence of infections

Time frame: Baseline and 6 months

Healthcare cost

Assess the healthcare cost (ER admission, hospitalizations)

Time frame: 6 months