Table 5.
Time points and measurements
| Enrolment | T0 | T1 | T2 | T3 | T4 | T5 | T6 | T7 | Registered in/with: | |
|---|---|---|---|---|---|---|---|---|---|---|
| Eligibility screen | x | |||||||||
| Informed consent | x | |||||||||
| Allocation | x | |||||||||
| Interventions | T0 | T1 | T2 | T3 | T4 | T5 | T6 | T7 | ||
| Intervention group | Download mobile application | x | ||||||||
| Wear activity tracker | O | O | O | O | O | O | ||||
| Control group | Wear activity tracker | O | O | O | O | O | O | |||
| Data measurements | T0 | T1 | T2 | T3 | T4 | T5 | T6 | T7 | ||
| Baseline characteristics | General characteristics | x | Sex, age, ASA, BMI, smoking, alcohol intake | |||||||
| Disease related characteristics | x | Disease, operation | ||||||||
| eHealth literacy assessment | x | eHEALS | ||||||||
| Protocol compliance (as reported by patients) | 1. Cessation of smoking and excessive intake of alcohol | x | Y/N questions in app or with paper form | |||||||
| 2. Preoperative nutritional screening and, as needed, assessment and nutritional support | x | Y/N questions in app or with paper form | ||||||||
| 3. Preoperative carbohydrate treatment | x | Y/N questions in app or with paper form | ||||||||
| 4. Preoperative prophylaxis against thrombosis | x | Y/N questions in app or with paper form | ||||||||
| 5. Early mobilization (day of surgery) | O | O | Y/N questions in app or with paper form | |||||||
| 6. Early intake of oral fluids and solids (offered the day of surgery) | O | O | Y/N questions in app or with paper form | |||||||
| 7. Early removal of urinary catheters and intravenous fluids (morning after surgery) | O | Y/N questions in app or with paper form | ||||||||
| 8. Use of laxatives | O | Y/N questions in app or with paper form | ||||||||
| 9. Intake of protein and energy-rich nutritional supplements | O | Y/N questions in app or with paper form | ||||||||
| 10. Prepare for early discharge | O | Y/N questions in app or with paper form | ||||||||
| Postoperative data ≤30 days (retrospective collection) | Length of hospital stay | x | EHR | |||||||
| Overall morbidity ≤30 days | x | EHR | ||||||||
| Complications | x | Clavien-Dindo minor: I-II major: III-V | ||||||||
| Reoperations | x | EHR | ||||||||
| Readmission ≤30 days | x | EHR | ||||||||
| In-hospital mortality | x | EHR | ||||||||
| Gastrointestinal | Tolerance of solid food | O | Days | |||||||
| Absence of nausea | O | Days | ||||||||
| Passage of first flatus | O | Days | ||||||||
| Passage of first stool | O | Days | ||||||||
| Weight - preoperative | x | Weight at admission, KG | ||||||||
| Weight - at discharge | x | Weight at discharge, KG | ||||||||
| Activity | Mean preoperative physical activity (steps/day) | O | Activity tracker, steps per day | |||||||
| Postoperative physical activity (steps/day) | O | O | O | Steps per day | ||||||
| Pain | Perceived pain daily postoperative - discharge | O | NRS 1–10* | |||||||
| Compliance with intake of (pain) medication | O | Y/N questions in app or with paper form | ||||||||
| Self-registered questionnaires | T0 | T1 | T2 | T3 | T4 | T5 | T6 | T7 | ||
| PROMS | General quality of life (WHOQol) | x | x | x | x | WHOQoL - BREF | ||||
| Multidimensional fatigue assessment | x | x | x | Multidimensional fatigue inventory | ||||||
| Physical Activity (IPAQ) | x | x | x | x | IPAQ-short | |||||
| Disability | x | x | WHODAS2 | |||||||
| Patient satisfaction questionnaire | x | Self-developed patient satisfaction questionnaire | ||||||||
T0: Moment of randomization; T1: 1–7 days before stay in hospital; T2 hospital admission; T3: day of surgery; T4: 1–7 days after surgery; T5: 8–14 days after surgery; T6: 15 days – 21 days after surgery; T7: 22–42 days after surgery
x: the event/action is performed or assessed once in the indicated time slot. O: the event/action is performed or assessed continuously in the indicated time slot. *Numeric rating scale