promoting Medication AdheRence and Self-management among kidney transplant recipients: a randomized controlled trial (the MARS Trial)
Recruiting
- Conditions
- Transplantatiekidney transplantationRenal transplantation10038430
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 324
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main parameter/endpoint of the study is the difference in adherence to the<br /><br>immunosuppressive medication between patients in the control group and patients<br /><br>in the experimental condition, as measured with electronic monitoring. The<br /><br>electronic monitoring device can be adjusted to the dosette box for medication<br /><br>which is used by the majority of patients after transplantation. After taking<br /><br>the immunosuppressive medication the patient needs to push the button of the<br /><br>device, so medication intake can be registered. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Medication nonadherence will be primarily measured with electronic measuring.<br /><br>However, measuring medication adherence is very complex. Therefore, secondary<br /><br>measures for medication nonadherence are included. A composite adherence score<br /><br>will be calculated, based on self-report of the patient, collateral report of<br /><br>an important person in the social network of the patient and a collateral<br /><br>report of the nephrologist of the patient. Furthermore, biological markers such<br /><br>as intrapatient variability of medication bloodlevels will be assessed as well.<br /><br>Other secondary outcome measures are self-management, quality of life and other<br /><br>mental health outcomes. Since the social network plays in important role in the<br /><br>intervention relationship quality will be assessed, as well as quality of life<br /><br>and mental health of an important other in the social network. </p><br>