Baselinea | Week 12 | Week 24 | Week 52 | Discontinuation of therapy | Discontinuation of follow-up | |
---|---|---|---|---|---|---|
Demographic and clinical data | ||||||
Eligibility | ✓ | |||||
Centre | ✓ | |||||
Date of birth | ✓ | |||||
Gender | ✓ | |||||
Ethnicity | ✓ | |||||
Marital status/dependents | ✓ | |||||
Living arrangements | ✓ | |||||
Usual place of residence | ✓ | |||||
Educational level | ✓ | |||||
Group membership | ✓ | ✓ | ||||
Height and weight | ✓ | |||||
Employment status | ✓ | |||||
Benefits/pensions status | ✓ | |||||
Start of current illness | ✓ | |||||
Start of disabling episode | ✓ | |||||
Comorbid medical conditions | ✓ | ✓ | ✓ | ✓ | ✓ | |
Medications and therapies | ✓ | ✓ | ✓ | ✓ | ✓ | |
Oxford criteria | ✓ | ✓ | ✓ | |||
CDC criteria/CDC symptoms | ✓ | ✓ | ✓ | |||
London criteria | ✓ | ✓ | ✓ | |||
Fibromyalgia | ✓ | ✓ | ✓ | |||
Past medical history | ✓ | |||||
Preferred intervention group | ✓ | |||||
Adverse events | ✓ | ✓ | ✓ | ✓ | ||
Therapist data c | ||||||
Primary qualification | ✓ | |||||
Years of experience | ✓ | |||||
Years of relevant experience | ✓ | |||||
Employment grade | ✓ | |||||
Doctor data c | ||||||
Discipline | ✓ | |||||
Employment grade | ✓ | |||||
Questionnaires | ||||||
Chalder fatigue | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
SF-36 physical functioning | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Participant CGI | ✓ | ✓ | ✓ | ✓ | ✓ | |
Doctor CGI | ✓ | ✓ | ✓ | |||
Therapist CGI | ✓ | ✓ | ✓ | |||
Walking test | ✓ | ✓ | ✓ | ✓ | ||
Actigraphy | ✓ | |||||
HADS | ✓ | ✓ | ✓ | ✓ | ✓ | |
Self-efficacy | ✓ | ✓ | ✓ | ✓ | ✓ | |
WSAS | ✓ | ✓ | ✓ | ✓ | ✓ | |
SIQb | ✓ | ✓ | ✓ | ✓ | ||
PHQ-15 | ✓ | ✓ | ✓ | ✓ | ✓ | |
Exercise and activity | ✓ | ✓ | ✓ | ✓ | ✓ | |
Jenkins Sleep Scale | ✓ | ✓ | ✓ | ✓ | ✓ | |
Step test | ✓ | ✓ | ✓ | ✓ | ✓ | |
Borg Scale | ✓ | ✓ | ✓ | ✓ | ✓ | |
Participant satisfaction | ✓ | ✓ | ||||
SSMC/therapy adherence | ✓ | ✓ | ✓ | ✓ | ||
EQ-5D | ✓ | ✓ | ✓ | ✓ | ||
CSRI | ✓ | ✓ | ✓ | ✓ |