Skip to main content

Table 2 Study design

From: E-nergEYEze, a vision-specific eHealth intervention based on cognitive behavioral therapy and self-management to reduce fatigue in adults with visual impairment: study protocol for a randomized controlled trial

  

Study period

Enrolment

Baseline assessment

Allocation

Post-allocation assessments

Timepoint

T -1

T 0

T 1

T 2

T 3

T 4

Enrolment:

       

 Informed consent

X

      

 Eligibility screening

X

      

 Baseline assessment

 

X

     

 Randomization

  

X

    

Intervention:

       

E-nergEYEze

 

X

 

X

X

X

X

Care as usual

 

X

 

X

X

X

X

Assessments:

       

General questionnaire

 

X

     

Primary outcome

X

   

X

 

X

Secundary outcomes

       

- Clinical effectiveness

 

X

 

X

X

X

Xa

- Cost effectiveness

 

Xb

 

X

Xb

X

Xb

Process evaluation

 

X

  

Xc

  

Working mechanism

 

X

  

X

 

X

  1. aAdditional assessment “Past life Events”
  2. bAdditional assessment “Euroqol-5 Dimensions with 5 levels”
  3. cAdditional assessment for intervention group “Dutch Mental Healthcare thermometer”