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Table 3 IBD-BOOST RCT screening and data collection schedule (SPIRIT figure)

From: Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial

 

Pre-consent

Pre-baseline

Baseline

6 months

12 months

Ongoing or during treatment

Screen for eligibility

X

     

Study within a trial (SWAT) randomisation

X

     

Invite reply

X

     

Consent form

 

X

    

Red flags assessment

 

X

    

Adverse event form

     

X

Drop-out event form

     

X

Faecal calprotectin test

 

X

    

Baseline case report form

  

X

   

Follow-up case report form

   

X

X

 

Participant qualitative interviews

  

X

 

X

 

Clinician qualitative interviews

  

X

 

X

 

Randomisation

  

X

   

Nurse support

   

X

  

Intervention website user query

   

X

  
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Trials

ISSN: 1745-6215