131 6 Better Stoma Care using the Stoma App – does it help? RESULTS A total of 263 participants provided informed consent and were randomized. Of these participants, 36 participants did not receive the treatment allocation (did not download or use the Stoma App), 96 participants received the full version Stoma App (intervention group) and 112 received the restricted version of the Stoma App (control group, figure 2). The baseline characteristics of the participants, as presented in Table 1, were similar between the two groups except for a significantly worse overall preoperative performance score in the intervention group (87.0 vs 89.6, p=0.041). The mean age of the study population was 56 years; the majority received a colostomy (59.6%) and the majority was operated upon in a non-acute, elective setting (63.5%). Both groups expressed overall sufficient scores on the mobile proficiency questionnaire. On average, patients in the elective setting started using the app 21 days before surgery, while patients in the emergency setting started using the app 5 days after surgery. From the patients in the intervention group, 20.1% utilized the peer contact function at least once. The results on the Stoma QoL questionnaire at two weeks, one month and three months postoperatively are presented in Table 2. At first sight, it appears that there were no significant improvements in the Stoma QoL for the intervention group. However, after adjusting for confounding factors using multivariate linear regression analysis, a significant improvement in reported quality of life was observed at the timestamp of one month postoperative (Table 3). Confounders included the quality of life at baseline, the readmission rate, and reported psychological problems. Patients in both groups had five contact moments (face-to-face or telephonic) at the outpatient clinical with a stoma nurse in the postoperative phase. Patients in academic medical centres had significantly fewer contacts in total, compared to patients in teaching hospitals (2.1 vs. 2.8 at one month p=0.019; 1.5 vs 2.8 at three months p<0.001). This was independent from the incidence of stoma related problems, suggesting different postoperative pathways or low-threshold contact in teaching hospitals. Self-reported problems were present in both the intervention and control groups. Physical problems were reported by 74.3% vs. 69.4% of patients at one month (p=0.500) and 68.5% vs. 65.6% at three months interval (p=0.411). Similarly, psychological problems were reported by 72.2% vs. 73.2% of patients at one month (p=1.000) and 68.1% vs. 64.8% at three months (p=0.740). The readmission rate of the intervention group was significantly higher at one month after surgery (20.4% vs 10.0%, p=0.047). Most readmissions were due to intra-abdominal abscesses (7.2%) or ileus (2.4%), see Table 4. The number of reported comorbidities in the intervention group was significantly lower (9.7% vs. 20.9%). Other clinical and patient-reported outcomes were comparable between the groups (Table 5).
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