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Table 4 Schedule of Data Collection Methods and Procedures

From: Complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in primary health care (EIRA study): study protocol for a hybrid trial

    Pre-implementation/Pre-study consent/screening During implementation Post-implementation
Activity/Assessment Data collection Responsible Study baseline Intervention visits Follow-up 12-months
PHC centre level
 Characteristics of assigned people Form report Research team each autonomous community x     
 Organisational structure Form report Research team each autonomous community x     
 Survey of Organizational Attributes for Primary Care Self-administered questionnaire Research team each autonomous community x     x
Professional level
 Age, sex, academic education and experience in PHC Self-administered questionnaire Research team each autonomous community x     
 Daily consumption of fruits and vegetables/Level of physical activity/Smoking behaviour Self-administered questionnaire Research team each autonomous community x     x
 Appropriateness and acceptability Self-administered questionnaire Research team each autonomous community x     x
 Determinants of implementation (CFIR constructs) Focus group Research team each autonomous community      x
Participant level
 Informed consent Paper document PHC professionals x     
 Age and sex CRF PHC professionals x     
 Screening unhealthy behaviours CRF PHC professionals x     
 Inclusion/Exclusion criteria CRF PHC professionals x     
 Adherence to the Mediterranean dietary pattern CRF (14-item Questionnaire of Mediterranean diet adherence External unit of local trained personnel   x   x  
 Quality of diet CRF (Diet Quality Index-International) External unit of local trained personnel   x   x  
 Physical activity behaviour CRF (International Physical Questionnaire) External unit of local trained personnel   x   x  
 Smoking behaviour CRF (interview and optional cooximetry) External unit of local trained personnel   x   x  
 Stage of change CRF PHC professionals (intervention group)   x   x  
External unit of local trained personnel (control group)   x   x  
 Health-related quality of life CRF (EuroQol-5D questionnaire) External unit of local trained personnel   x   x  
 Number in the last 12 months of: hospital care (emergency visits and stays), secondary care (visits to specialists), primary care (visits to physician and nurse), social care services (visits to social worker), outpatient diagnostic tests, medication use, group sessions attended, community resources used and loss of productivity (days off work). CRF Computerised pharmacy records Electronic health record External unit of local trained personnel   x   x  
 Body mass index, waist circumference, blood pressure and lipid profile CRF External unit of local trained personnel   x   x  
 Cardiovascular risk CRF (REGICOR and SCORE function charts) External unit of local trained personnel   x   x  
 Arterial stiffness CRF (measured by the Vascular Screening System VaSera VS-1500 N or VaSera VS-2000) External unit of local trained personnel   x   x  
 Ankle-brachial index CRF (measured by the Vascular Screening System VaSera VS-1500 N or VaSera VS-2000) External unit of local trained personnel   x   x  
 Functional social support CRF (questionnaire Duke-UNC-11) External unit of local trained personnel   x   x  
 Risk of depression CRF (algorithm PredictD) External unit of local trained personnel   x   x  
 Anxiety CRF (General Anxiety Disorder-7 questionnaire) External unit of local trained personnel   x   x  
 Depression CRF (Patient Health Questionnaire-9 and the Composite International Diagnostic Interview External unit of local trained personnel   x   x  
 Appropriateness and acceptability of intervention Self-administered questionnaire PHC professionals intervention group    x x  
 Determinants of implementation (CFIR constructs) Focus group Research team each autonomous community      x
  1. CFIR Consolidated Framework for Implementation Research, CRF Case Report Form, PHC Primary Health Care