Transplantatie kidney transplantation Renal transplantation
Conditions
Interventions
During the RCT participants will be assigned to the experimental condition
(intervention group) or the control group.
Intervention group: Patients assigned to the intervention group will receive an
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Functioning kidney transplant - Aged 12 years and above (no upper limit set) - Report of nonadherence (to immunosuppressive medication) by either the patient (self-report), medical specialist (collateral report) or important other (collateral report)
Exclusion criteria
Exclusion criteria: - Patients who are not classified as non-adherent to the immunosuppressive medication based on a composite adherence score - Patients on dialysis at the start of the intervention - Insufficient level of speaking and understanding Dutch language to complete the questionnaires - Pre-transplant patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main parameter/endpoint of the study is the difference in adherence to the immunosuppressive medication between patients in the control group and patients in the experimental condition, as measured with electronic monitoring. The electronic monitoring device can be adjusted to the dosette box for medication which is used by the majority of patients after transplantation. After taking the immunosuppressive medication the patient needs to push the button of the device, so medication intake can be registered. | — |
Secondary
| Measure | Time frame |
|---|---|
| Medication nonadherence will be primarily measured with electronic measuring. However, measuring medication adherence is very complex. Therefore, secondary measures for medication nonadherence are included. A composite adherence score will be calculated, based on self-report of the patient, collateral report of an important person in the social network of the patient and a collateral report of the nephrologist of the patient. Furthermore, biological markers such as intrapatient variability of medication bloodlevels will be assessed as well. Other secondary outcome measures are self-management, quality of life and other mental health outcomes. Since the social network plays in important role in the intervention relationship quality will be assessed, as well as quality of life and mental health of an important other in the social network. | — |
Countries
Netherlands
Outcome results
None listed