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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.).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunosuppressive | Drug | Immunosuppressive therapies |
| 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 |
| 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. |
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Inclusion criteria:
Exclusion criteria:
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Kidney transplant recipients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O.U. Consorziale Policlinico | Bari | Italy | ||||
| A.O.U. Policlinico S.Orsola Malpighi |
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| ID | Term |
|---|---|
| D007166 | Immunosuppressive Agents |
| ID | Term |
|---|---|
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| 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 |
| 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 |
| A.O. Ospedale Circolo e Fondazione Macchi | Varese | Italy |
| A.O.U.I. Ospedale Borgo Trento | Verona | Italy |