The Adherence of Immunosuppressive Therapy Including Tacrolimus Once-daily in Italian Kidney Transplant Recipients
- Conditions
- Kidney Transplant
- Registration Number
- NCT03558373
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
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.).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 158
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Non aderence 6 months 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.
- Secondary Outcome Measures
Name Time Method BAASIS evaluation Baseline 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.
Graft failure Baseline and 6 months Occurrence of graf failure
BMQ score Baseline and 6 months 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.
Clinical informations as for clinical practice Baseline and 6 months Collect clinical information (e.g. routine tacrolimus trough levels, eGFR if available)
ACCEPT score Baseline and 6 months 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).
Rejections Baseline and 6 months Occurrence of rejection episodes
Adverse events Baseline and 6 months Number of adverse events
Infections Baseline and 6 months Occurrence of infections
Healthcare cost 6 months Assess the healthcare cost (ER admission, hospitalizations)
Patients characteristics Baseline 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.
Immunosuppressive treatments Baseline and 6 months Immunosuppressive treatments description and changes
Trial Locations
- Locations (12)
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
A.O.U. Consorziale Policlinico
🇮🇹Bari, Italy
A.O.U. Policlinico S.Orsola Malpighi
🇮🇹Bologna, Italy
A.O.U. Pisana P.O. Cisanello
🇮🇹Pisa, Italy
ARNAS Ospedale Civico
🇮🇹Palermo, Italy
A.O.U. Maggiore della Carità
🇮🇹Novara, Italy
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Ospedale Cisanello
🇮🇹Pisa, Italy
Fondazione Policlinico Univ. Gemelli
🇮🇹Roma, Italy
A.O.U. Città della Salute e della Scienza
🇮🇹Torino, Italy
A.O. Ospedale Circolo e Fondazione Macchi
🇮🇹Varese, Italy
A.O.U.I. Ospedale Borgo Trento
🇮🇹Verona, Italy