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Table 1 Study assessments

From: A study of sertraline in dialysis (ASSertID): a protocol for a pilot randomised controlled trial of drug treatment for depression in patients undergoing haemodialysis

 

Screening

Psychiatric interview

Entry to clinical trial

1-2 weeks

1 month

2 months

3 months

4 months

5 months

6 months

Informed Consent

X

X

X

       

Inclusion/exclusion criteria fulfilled

X

X

X

       

Demographics

X

         

Co-morbid conditions (self-report)

X

         

Charlson Co-morbidity Index [29]

  

X

 

X

X

X

X

X

X

Brief psychiatric history

X

         

BDI-II [23]

X

        

X

PHQ-9 [26]

X

  

X

X

X

X

X

X

X

P4 Suicidality Screener [33]

   

X

X

 

X

 

X

 

Psychiatric Assessment

 

X

 

X

 

X

 

X

 

X

Montgomery- Asberg Depression Rating Scale [25]

 

X

   

X

 

X

 

X

Mini International Neuropsychiatric Interview [24]

 

X

        

List of medications

  

X

 

X

X

X

X

X

X

Description of dialysis treatment

  

X

 

X

X

X

X

X

X

Mid-week pre and post dialysis blood pressure

X

 

X

 

X

X

X

X

X

X

Dry weight

X

 

X

 

X

X

X

X

X

X

Adherence to dialysis treatment

X

 

X

 

X

X

X

X

X

X

Interdialytic weight gain

X

 

X

 

X

X

X

X

X

X

Urine volume per 24 h

X

         

Dialysis adequacy Kt/V

X

 

X

 

X

X

X

X

X

X

Dialysis time

X

 

X

 

X

X

X

X

X

X

Urea & electrolytesa

X

 

X

 

X

X

X

X

X

X

Full blood countb

X

 

X

 

X

X

X

X

X

X

Liver function testsc

  

X

 

X

X

X

X

X

X

Electrocardiogram

  

X

  

X

 

X

 

X

IMP review

    

X

X

X

X

X

X

Drug compliance

   

X

X

X

X

X

X

X

Sertraline Plasma blood test

       

X

  

Baseline assessment of signs and symptoms

  

X

       

Adverse events

   

X

X

X

X

X

X

X

Kidney Disease QoL questionnaire [30]

  

X

  

X

 

X

 

X

Euroqol EQ 5D questionnaire [22, 31]

  

X

  

X

 

X

 

X

Clinical Global Impression Severity Scale [28]

 

X

   

X

 

X

 

X

Clinical Global Impression Improvement Scale [28]

     

X

 

X

 

X

  1. aUrea, Creatinine, Calcium, Sodium, Potassium and Bicarbonate
  2. bHaemoglobin, White blood cell count and platelets
  3. cBilirubin, Albumin, Alanine transaminase (ALT), Aspartate transaminase (AST), Aspartate Aminotransferase, Calcium, Phosphate and C-Reactive Protein