Table 4 Schedule of Data Collection Methods and Procedures
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 | ||||