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Table 5 Time points and measurements

From: Improving enhanced recovery after surgery (ERAS): ERAS APPtimize study protocol, a randomized controlled trial investigating the effect of a patient-centred mobile application on patient participation in colorectal surgery

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
  1. 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
  2. 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