Steering committee meeting, Crete

1. Determinants of Successful Implementation of Selective Prevention of Cardio-metabolic Diseases Across Europe - WP8: Initial design for the feasibility studies Christos Lionis, MD PhD FRCGP (Hon) FWONCA Professor of General Practice and Primary Health Care Head of Clinic of Social and Family Medicine School of Medicine, University of Crete, Greece and AgapiAngelaki, UoC researcher On behalf of the research team of UoC: ThodorisVasilopoulos, Eirini Trachanatzi, DionisisVarthilis Steering committee meeting, Crete “This presentation is part of the project / joint action ‘663309 / SPIM EU’ which has received funding from the European Union’s Health Programme (2014-2020).” “The content of this presentations the views of the author only and is his/her sole responsibility; it can not be considered to reflect the views of the European Commission and/or the Consumers, Health, Agriculture and Food Executive Agency or any other body of the European Union. The European Commission and the Agency do not accept any responsibility for use that may be made of the information it contains.”

2. About WP8 Start Month: 22 (February 2017) End Month: 34 (February 2018) Participants: UOC, NIVEL, UMC UTRECHT, CUNI, SDU, KI Tasks: • Task 8.1 Preparation of feasibility studies in five EU Member States (M22-M24) • Task 8.2 Implementation of feasibility studies in five EU Member States (M25-M30) • Task 8.3 Analyses of results of feasibility studies (M30-M31) Deliverable: • Deliverable 8.1 Protocol for implementing feasibility studies (M25) • Deliverable 8.2 Database of feasibility studies in five EU Member States completed (M30) • Deliverable 8.3 Final report on feasibility studies (M34)

3. Aim of WP8 and main objectives of the feasibility study The overall aim of WP8 is: To test the feasibility of implementing the tailored selective prevention programs (designed in WP7) in five EU Member States (SWE, DNK, CZE, NLD, GRE) with regards to their acceptance and participation rate. The main objectives of the feasibility are: 1. To explore recruitment rates. 2. To explore completion rates. 3. To measure the extent of missing data. 4. To assess whether respondents accepted the intervention. 5. To assess whether the budget of the study was sufficient as originally planned. 6. To measure the time per participant required. 7. To measure the range and standard deviations of measures. 8. To measure the extent of changes after implementing the planned interventions. 9. To measure the investigator’s satisfaction.

4. Target population • aiming at GPs at selective prevention of cardio-metabolic diseases as a routine task for primary care. • routine task: identify individuals at high risk of cardio-metabolic diseases but without symptoms or complaints

5. Design and protocol for the feasibility studies - I • A feasibility study will be carried out in primary care practices from five European Member States (Sweden, Denmark, the Netherlands, Czech Republic and Greece) Definition of a feasibility study A feasibility study aims to objectively and rationally uncover the strengths and weaknesses of an existing business or proposed venture, opportunities and threats present in the environment, the resources required to carry through, and ultimately the prospects for success. Appropriate Areas of Focus • Acceptability. This relatively common focus looks at how the intended individual recipients—both targeted individuals and those involved in implementing programs—react to the intervention. • Practicality. This focus explores the extent to which an intervention can be delivered when resources, time, commitment, or some combination thereof are constrained in some way. Justis, R. T. & Kreigsmann, B. (1979). The feasibility study as a tool for venture analysis. Business Journal of Small Business Management 17 (1) 35-42. Georgakellos, D. A. & Marcis, A. M. (2009). Application of the semantic learning approach in the feasibility studies preparation training process. Information Systems Management 26 (3) 231-240.Am J Prev Med. Author manuscript; available in PMC 2010 Apr 25.

6. Design and protocol for the feasibility studies -II Key issues: • The feasibility study will be tailored to the context in each country, which is the result of WP7. • A study protocol will be developed and approved by the SPIM EU steering committee before the start of the feasibility study. • The protocol and feasibility study will receive approval by local authorities and National Bioethics Committees in the participating countries, according to local legislation framework. • A timeframe is needed to be discussed to avoid any potential delay. • All participants should clarify the time that is usually needed from the submission of the application until the bioethical approval.

7. Theoretical Framework - The Health Belief Model • The HBM model seems to be a suitable framework regarding health behavior issues that could assess health beliefs and predict health behavior. • The HBM could indicate the reasons for accepting or rejecting a selective prevention programme. Source: Conner, M. & Norman, P. (1996). Predicting Health Behavior. Search and Practice with Social Cognition Models. Open University Press: Ballmore: Buckingham. Janz NK, Marshall H, Becker (1984). "The Health Belief Model: A Decade Later". Health Education & Behavior. 11 (1): 1–47. doi:10.1177/109019818401100101).

8. Setting and participants – I • Geographically well-defined areas (districts) in the participating countries. • Eligible would be all primary care practices serve the district. • A maximum of ten (10) primary care practices will be invited to participate. • Eligibility criteria: The selection of practices will be based on criteria to ensure that different practice settings are represented: • public/private, • solo/group, • different urbanisation levels (In Greece: geographically well-defined primary care areas in Greece (rural Crete and possibly in a largest area of Thessali in northern Greece) • Primary care areas will be randomized into an intervention and a control group; • 5 primary care practices will be exposed to the intervention program. • 5 control practices will be recruited, will not be exposed to the intervention (usual care). • a before and after assessment in the two groups will follow the intervention program. • Primary care practices (i.e. primary care physicians and nurses) working in each setting/practice will be invited to participate. • Subjects:in each practice a random sample of 20 persons attending each practice will be recruited.

9. Setting and participants-II • Inclusion criteria: • persons aged 45-70 years old • persons without any known lifestyle risk factor (obesity and/or smoking), based on their personal health records, on physical examination and risk score. • persons without any known risk of cardio-metabolic disease, based on their personal health records, on physical examination and risk score. • Classification of Cardio-metabolic Risk: • Age Groups • Metabolic Syndrome • Smoking • Alcohol consumption • Inflammatory markers • Insulin resistance • Obesity (BMI)

10. Tailored Intervention Training • Recruitment: • Consent form. • Invitation letter. • Information letter. • After one week: Intensive one-day educational coursein small group discussion online or face to face, role playing, patient stimulation, poster and leaflets, and audio recorded sessions in each participating EU Member State. • Baseline participants questionnaire • General health-related life style: Smoking/ Alcohol • Risk factor assessment and principles of motivational interviewing and as well as behavioral change • Description on HBCVD Scale • Stimulated Patient visits • Follow up after two months. • The Health Beliefs related to cardiovascular disease Scale (HBCVD) and examines the perceived Susceptibility and perceived benefits of diet and exercise. • General health-related life style: Smoking / Alcohol • Risk factor assessment • Stimulated Patient visits • Follow up EVALUATION phone calls after four months on the intervention (suggestion).

11. Tailored intervention: a diagrammatic presentation After one week After one week Follow up After four week Follow up After four week Follow up After two months Follow up after four week

12. Instruments and tools • In a tailored intervention, which may consist of life-style related interventions:The Health Beliefs related to cardiovascular disease Scale (HBCVD) and examines the perceived Susceptibility and perceived benefits of diet and exercise. • A cardio-metabolic risk factor assessment (e.g. Dutch Guidelines – Protocol) • Life-style, practices, including smoking , alcohol consumption, dietary recommendations (SDSCA - http://care.diabetesjournals.org/content/23/7/943.full.pdf (survey) • General health-related life style: RAPA for physical exercise (9 items)medication (http://depts.washington.edu/hprc/rapa - 9 items (survey) • MESA Typical Week Physical Activity Survey (TWPAS) – 28 items (interview) - https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/GetPdf.cgi?id=phd001727.2 • Demographic data: age, sex, family situation, education, employment status, sick leave, ethnicity, housing, global household income, comorbidities. Items from validated surveys will be chosen, such ESS. (European Social Survey - http://www.europeansocialsurvey.org/ (demographics)

13. The Health Beliefs related to cardiovascular disease Scale (HBCVD) and examines the perceived Susceptibility and perceived benefits of diet and exercise

14. Statistical analysis • The power of the study and the sample size will be estimated according: • to specific assumptions based on literature and in coordination with the Department of Biostatistics of the University of Crete. • Due to the nature of feasibility study, the data analysis will be based on descriptive statists.

15. Outcomes relevant to PHC practices and practitioners • Number and percentage of practitioners who identified the tailored selective prevention programme as feasible, practical and acceptable. • Number and percentage of practitioners who will consider the selective prevention programmeas important and valuable for their daily practice. • The estimated time needed for the implementation of the selective prevention programme by the PHC professionals on their daily routine.

16. Outcomes relevant to participating PHC visitors • The number and percentage participants completed the selectivepreventionprogram. • The extent participants considered the program as useful, as relevant for their health status, whether they intend to undertake risk reducing actions and what barriers they experience in undertaking such actions. • The number of participants who decided to change the health behaviourrelevant to at least one of the known risk factors.

17. Financial issues • Remuneration of primary care practices for their participation in the feasibility study (WP8): • € 500 * 10 practices * 5 EU Member States. • The amount of remuneration (average 500€) will depend on the number of respondents and on the GDP level of the country.

18. We thank you. “This presentation is part of the project ‘717319 / EUR-HUMAN’ which has received funding from the European Union’s Health Programme (2014-2020).” “The content of this presentations the views of the author only and is his/her sole responsibility; it can not be considered to reflect the views of the European Commission and/or the Consumers, Health, Agriculture and Food Executive Agency or any other body of the European Union. The European Commission and the Agency do not accept any responsibility for use that may be made of the information it contains.”