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

Table 3 Summary of study assessments and treatment telephone calls

	Study period
	Enrolment	Allocation	Post-allocation							Close-out
Timepoint (time in weeks)	−t1	0	1	3	5	7	9	11	14 (+/−1)^*	16	26
Enrolment
Consent and screening	X
Randomisation	X
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

*The booster treatment telephone call can take place at 13, 14 or 15 weeks post-randomisation
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

ISSN: 2055-5784