Page 111 - Exploring the Potential of Self-Monitoring Kidney Function After Transplantation - Céline van Lint

Self-monitoring of renal function: a randomised trial 109
Within the eligible population, 119 patients (77%) signed an informed consent. The main reason for not wanting to participate was the anticipated additional burden of self-monitoring (N=17, 47%). Sixty- five patients were randomized to the intervention group. After randomization, 3 patients dropped out because of graft dysfunction, death and cancellation of transplantation (none was study related). Four patients cancelled their participation before starting to self-monitor kidney function at home, because of limited trust in the creatinine device, difficulties when logging on the SMSS, business rush or a worsened condition post-transplantation. The number of patients eligible for intention-to-treat analysis was 62 in the intervention and 51 in the control group. See figure 3 for the study flow-chart. Sample characteristics are shown in table 1 for both the intention-to-treat and per protocol population. Intervention and control group were similar on all variables, except for diabetes. The intervention group contained significantly more patients with diabetes, which pertained to both the intention-to-treat and per protocol population (p .03 and .01, respectively). Sensitivity analyses adjusting for diabetic status were therefore performed. The interviewed population was a representative sample of all intervention patients with a mean age of 51 years, a 70/30 male/female ratio, 50% pre-emptive and 85% living donor transplantations.
3.1. Self-monitoring kidney function after transplantation is non-inferior to regular care Figure 4 shows the development over time of eGFR, quality of life and blood pressure. Significant improvements over time were found for eGFR (p .025, 95% CI [.546 – 8.066]), systolic (p .009, 95% CI [-11.481 – -1.673]) and diastolic blood pressure (p .018, 95% CI [-6.499 – -.623]) and physical (p .000, 95% CI [14.855 – 32.384]) and mental QoL (p .004, 95% CI [3.809 – 19.408]), independent of study group (see table 2). Mean number of SAEs for both the intervention and control group is shown in figure 5. Total number of SAEs was similar for intervention and control patients (p .117, 95% CI [-1.012 – .114]), see table 3. Sensitivity analyses controlling for diabetes led to a loss of the statistically significant improvement over time for eGFR, blood pressure and quality of life (data not shown). Number of SAEs was significantly lower for the intervention compared to the control group when controlling for diabetes (p .046, 95% CI [-1.178 – -.010]).
Level of general satisfaction about care remained stably high over time in both study groups with a mean score of around 29 on a scale with a maximum of 32 (see figure 4 and table 2). During the interviews, intervention patients also reported high levels of satisfaction with self-monitoring (N=20). Nineteen out of 20 interviewees (95%) would recommend self-monitoring to other kidney transplant patients. Further, 15 out of 20 (75%) indicated they would have liked to continue self-monitoring beyond the first year post-transplantation.
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