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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