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Table 1 Summary of baseline and follow-up measures

From: Evaluating the clinical and cost effectiveness of a behaviour change intervention for lowering cardiovascular disease risk for people with severe mental illnesses in primary care (PRIMROSE study): study protocol for a cluster randomised controlled trial

Measure

Source data

0 mth

6 mth

12 mth

1. Clinical measures

    

Total cholesterol (mmol/l)

Blood test

✓

✓

✓

HDL, LDL, Total cholesterol/HDL ratio (mmol/l)

Blood test

✓

✓

✓

HBA1c (mmol/mol, %)

Blood test

✓

✓

✓

Systolic and diastolic blood pressure (mm/hg)

Clinical assessment

✓

✓

✓

2. Anthropometric measures

    

BMI (kg/m2)

Clinical assessment

✓

✓

✓

Waist circumference (cm)

Clinical assessment

✓

✓

✓

3. Behavioural measures

    

Alcohol intake (AUDIT-C)

Researcher administered questionnaire

✓

✓

✓

Smoking status

Researcher administered questionnaire

✓

✓

✓

Diet (DINE)

Researcher administered questionnaire

✓

✓

✓

4. Medical records.

    

Active physical health conditions

Medical records

✓

 

✓

Service use (inpatient hospital stays, outpatient appointments, accident and emergency attendances, community service use, health checks and action plans)

Medical records

✓

 

✓

Prescribed medications

Medical records

✓

 

✓

CVD risk scores

Medical records

✓

 

✓

Scheduled appointments not attended

Medical records

✓

 

✓

5. Patient questionnaires

    

Service use: Employment, Housing, Health and Leisure (EHHaL)

Patient self-report questionnaire

✓

✓

✓

International Physical Activity Questionnaire (IPAQ)

Patient self-report questionnaire

✓

✓

✓

Quality of life: EQ-5D-5 L

Patient self-report questionnaire

✓

✓

✓

Wellbeing: The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)

Patient self-report questionnaire

✓

 

✓

Morisky Scale of Adherence (MMS): Psychiatric medications

Patient self-report questionnaire

✓

✓

✓

Morisky Scale of Adherence (MMS): CVD preventative medications

Patient self-report questionnaire

✓

✓

✓

Client Satisfaction Questionnaire - CSQ

Patient self-report questionnaire

✓

✓

✓