During their visit to the clinic, participants completed a baseline assessment booklet, which took approximately 30 to 45 minutes.
The baseline questionnaire booklet includes questions about age, gender, disease duration, medication use, prior treatments for knee pain and social circumstances.
The baseline assessment booklet contained: (i) Demographic questions regarding a participant's age, gender, weight, height, educational level, employment status, smoking status, and whether the participant was seeking care for LBP or taking medication.
The baseline psychosocial booklet included the Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith, 1983), the Multi-dimensional Health Locus of Control Scale (MHLCS) (Wallston et al, 1978) and a questionnaire designed specifically for use within TOMBOLA, the Process Outcome Specific Measure (POSM) (Gray et al, 2005).
Consenting women completed a baseline QL questionnaire booklet, administered by their hospital team in the outpatient clinic, before randomisation.
Older people receive this booklet at baseline and are requested to take it with them to each contact with professional health care providers for 18 months.
Procedure At baseline, participants received questionnaire booklets by mail in two waves: the first assessing socio-demographics, clinical data and diabetes-specific distress.
At baseline and follow-up the booklet consisted of OM-6, CIQ and all additional measurement tools as mentioned above.
The components of the British Heart Foundation booklet received at baseline were discussed in detail in relation to the participant's eating habits.
