Table 3 Schedule of data collection
Study Procedures | Face-to-face assessment | Post Treatment telephone call | Telephone, mail or online form assessment* | ||
|---|---|---|---|---|---|
Screening & Baseline Assessment | 6 Months | 12 Months | |||
Informed consent | ✓ | ||||
CRF | Inclusion/exclusion criteria | ✓ | |||
Medical history | ✓ | ||||
Demographics | ✓ | ||||
Clinical characteristics | ✓ | ||||
Assessments | Short Form 36 | ✓ | ✓ | ✓ | |
Functional Mobility Scale | ✓ | ✓ | ✓ | ||
Revised Illness Perception Questionnaire | ✓ | ✓ | ✓ | ||
Hospital Anxiety & Depression Scale | ✓ | ✓ | ✓ | ||
Client Service Receipt Inventory | ✓ | ✓ | ✓ | ||
EQ-5D-5 L | ✓ | ✓ | ✓ | ||
Work Productivity & Impairment Questionnaire | ✓ | ✓ | ✓ | ||
Clinical Global Impression Scale (CGI-I) | ✓ | ✓ | ✓ | ||
Fatigue State | ✓ | ✓ | ✓ | ✓ | |
Confidence in correctness of diagnosis | ✓ | ✓ | ✓ | ||
Extended Patient Health Questionnaire-15 | ✓ | ||||
Randomisation | ✓ | ||||
Adverse events screen | ✓ | ✓ | ✓ | ||
Satisfaction with intervention Questionnaire | ✓ | ||||
Participant description of intervention | ✓ | ||||
HES data obtained from NHS Digital and eDRIS services covering the previous 18 months | ✓ | ||||