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Table 1 Schedule of the enrollment, intervention, and assessments

From: Electronic health record nested pragmatic randomized controlled trial of a reminder system for serum lithium level monitoring in patients with mood disorder: KONOTORI study protocol

 

Study periods

 

Enrollment

Allocation

Post-allocation

Close-out

Timepoints

T-1

T0

T1-A

T1-B

T2-A

T2-B

Txe

Trial program

Enrollment

       

Screening

X

      

Randomizationa

 

X

     

Intervention

       

Reminder A

  

X

 

X

  

Reminder B

   

X

 

X

 

Assessments

       

Baseline characteristicsb

X

      

Treating physician

Enrollment

       

PRIME-MDc

X

      

Eligibility assessment

X

      

Informed consent

X

      

Assessments

       

Lithium concentrationd

X

     

X

Liver function

X

     

X

Kidney function

X

     

X

Thyroid function

      

X

  1. PRIME-MD Primary Care Evaluation of Mental Disorders
  2. aStratified block randomization will be conducted if the candidate has a measurement of serum lithium within 7 days of giving informed consent and an appointment between 4 and 8 months after giving informed consent
  3. bBasic information includes gender, age, and concomitant medication
  4. cThe candidate will be classified as having major depression, bipolar I disorder, or bipolar II disorder
  5. dSerum lithium will be classified into three groups (between 0.4 mEq/L and 1.0 mEq/L inclusive; < 0.4 mEq/L; or > 1.0 mEq/L)
  6. eThe first scheduled visit is between 18 and 24 months after informed consent
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