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Table 1 SPIRIT Trial study schedule of enrolment, interventions, and assessments

From: The effect of animated consent material on participants’ willingness to enrol in a placebo-controlled surgical trial: a protocol for a randomised feasibility study

Time-point

Enrolment

Randomisation

Post-allocation

− t1

0

t1

t2

t3

t4

Enrolment

 Baseline data, demographics

X

     

 Eligibility screen

X

     

 Informed consent

X

     

 Allocation

 

X

    

 Participant characteristics

  Health literacy

X

     

  General Healtha

X

     

  Symptom Severityb

X

     

Interventions

  Video animation

  

X

   

  Written information

  

X

   

Assessments

  Recruitment rate

   

X

X

 

  Therapeutic misconceptionc

   

X

X

 

  Qualitative study

   Think aloud interview

     

X

  1. aVR-12
  2. bOxford Shoulder Score
  3. cTherapeutic Misconception Scale
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Pilot and Feasibility Studies

ISSN: 2055-5784