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Table 3 Summary of study assessments and treatment telephone calls

From: Study protocol for POSITIF, a randomised multicentre feasibility trial of a brief cognitive-behavioural intervention plus information versus information alone for the treatment of post-stroke fatigue

 Study period
EnrolmentAllocationPost-allocationClose-out
Timepoint (time in weeks)−t10135791114 (+/−1)*1626
Enrolment           
 Consent and screeningX          
 RandomisationX          
 Allocation X         
Intervention           
 Telephone call 1  X        
 Telephone call 2   X       
 Telephone call 3    X      
 Telephone call 4     X     
 Telephone call 5      X    
 Telephone call 6       X   
 Booster telephone call        X  
Assessments
 Baseline assessments
  Two fatigue screening questions
  PHQ-9
  GAD-7
  SF-SIS cognitive item
  SF-SIS language item
  Screening questions about serious illness		 X         
 4 months follow-up assessments
  FAS
  PHQ-9
  GAD-7
  CBRQ
  EQ-5D-5 L		         X 
 6 months follow-up assessments
  FAS
  PHQ-9
    GAD-7
  CBRQ
  SF-SIS
  EQ-5D-5 L
  Anxiolytics (Y/N)
  Hours working
  Health costs		          X
  1. *The booster treatment telephone call can take place at 13, 14 or 15 weeks post-randomisation
  2. CBRQ Cognitive and Behavioural Responses Questionnaire, EQ-5D-5 L EuroQoL 5-dimension 5-level, FAS Fatigue Assessment Scale, GAD-7 Generalized Anxiety Disorder Assessment 7-item, PHQ-9 Patient Health Questionnaire 9-item, SF-SIS Short Form Stroke Impact Scale
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Pilot and Feasibility Studies

ISSN: 2055-5784