Page 128 - Exploring the Potential of Self-Monitoring Kidney Function After Transplantation - Céline van Lint

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Chapter 6
system (SMSS). As this SMSS automatically provided instructions for further actions (e.g. continue regular schedule or contact the hospital) upon registration of a new creatinine value, our final research goal was to determine whether patients adhered to the system’s instructions.
METHODS
Patients and study design
The data used in this study was obtained from the ADMIRE project (Assessment of a Disease management system with Medical devices In RENal disease), a cooperation between the Leiden University Medical Centre, the Technical University of Delft and the Dutch Organisation for Applied Scientific Research (TNO). This extensive project comprised the technical development of a SMSS in which several studies were performed to optimise the system to suit patient’s needs and wishes, as well as a prospective randomized controlled trial (RCT) to study whether self-monitoring kidney function supported by a SMSS can replace part of regular outpatient care without compromising on the quality of care. The study protocol was approved by the Medical Ethics Committee of the LUMC. Patients were eligible for participation in the RCT if they were about to receive a donor kidney or recently received one, were ≥ 18 years of age, mastered the Dutch language sufficiently, had access to Internet and had a creatinine level of ≤ 300 μmol/l within 4 weeks post-transplantation. Patients were excluded if they were visually impaired or were considered ineligible by their treating physician (e.g. due to mental retardation, a history of non-compliance to treatment). We therefore had a selection of patients that seemed most capable for engaging in self-monitoring
Recruitment of living donor recipients took place during a pre-transplant consultation with a nurse- practitioner. Recipients of a post mortem kidney were recruited during their post-transplantational stay in the hospital by the primary investigator (CvL). After this face-to-face introduction, patients received a written explanation of the study with an informed consent form. If a signed informed consent was not returned within two weeks from the recruitment date, patients were contacted telephonically to inquire whether they were interested in participating. After signing informed consent, each participant was assigned a study number. Incoming informed consents were treated in consecutive order. Study numbers were allocated to either the intervention or control group according to a pre-set randomization schedule which was created by a medical statistician. The randomization procedure was blinded for the project members directly involved in patient recruitment.