119 5 A personalized app to improve quality of life of patients with a stoma: A protocol for a multicentre randomized controlled trial Table 1: Study outcomes and time points. Data measurements T0 T1 T2 T3 T4 T5 Baseline characteristics General characteristics x Disease related characteristics x Postoperative outcomes Length of hospital stay x Overall morbidity x x x x Complications x x x x Reoperations x x x x Readmission x x x x In-hospital mortality x x x x Number of outpatients visits x x x x Self-reported problems x x x x Patient reported outcomes (PROMS) Mobile proficiency (MDPQ-16) x General quality of life (WHOQol) x x x Stoma quality of life (Stoma-QoL) x x x x x Disability (WHODAS2) x x x x Psychosocial adaption (OAI-23) x x x x x Patient satisfaction questionnaire x T0: At informed consent, T1: 2 weeks after surgery, T2: 1 month after surgery, T3: 3 months after surgery, T4: 6 months after surgery, T5: 12 months after surgery or end of follow-up Sample size calculation The quality of life of patients with stomas has been well described in the literature. In the study by Sier et al., the study population and the data analyses share similarities with the study proposed here.16 In the study by Sier et al., patients received additional stoma care, in terms of home visits by a stoma nurse. The results from the study by Sier et al. were used as the best estimated reference values to calculate the optimal sample size in the present study. The average quality-of-life score in the study by Sier et al., measured using the stoma quality-of-life tool (Stoma-QoL), was 63.4 (SD = 10.5) for the intervention group and 56.6 (SD = 10.9) for the control group. We assumed that a patient-centred application would be of greatest benefit in the immediate postoperative phase, when patients need to learn how to cope with a stoma. We hypothesize that the QoL of patients in the group allocated Stoma-APPtimize would increase with 5.0 point, compared with 56.6 in the control group. Using a sample size calculation with 90% power, a two-sided alpha of 0.05 and an SD of 10.7, we estimated that 98 participants per study group are needed. A loss to follow-up rate of 10% was also estimated. Therefore, the total target sample size was set at 208 participants ((2 × 98)/0.9 = 208).
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