Feasibility of a Preventive Program Against Lifestyle Related Diseases

Cardiovascular Diseases Clinical Trial

Official title:

Early Detection and Prevention of Lifestyle Related Diseases - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02797392
• Other study ID #: TOFpilot2016
• Secondary ID: 11/1324415/10562
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2019
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The continuously increasing prevalence of cardiovascular diseases, type-2 diabetes, and COPD is a major health problem in developed countries and is mainly caused by an unhealthy lifestyle. Most important lifestyle related causes of morbidity and mortality are smoking, obesity and physical inactivity, and increasing rates of obesity and physical inactivity in combination with smoking will lead to an increase in the number of patients with lifestyle related diseases in the coming decades. There is, therefore, an urgent need to identify and establish strategies and to implement interventions, allowing for the identification and management of citizens at increased risk of disease.

Two recent systematic reviews of general practice based health checks suggest that people at increased risk of a chronic disease may benefit from a targeted approach to health checks. Targeted or selective preventive actions are a generally accepted and well integrated part of the health care system (e.g. treatment of hypertension and hyperlipidemia). However, selective prevention is challenged in terms of how to identify citizens at increased risk of disease in the general population in order to start the indicated preventive actions.

The aim of the present pilot study is to test the acceptability, feasibility and short-term effect of a selective preventive program that systematically helps citizens evaluate individual risk of lifestyle related disease and offers targeted and coordinated preventive services in the primary health care sector.

The intervention comprises four elements: 1) Systematic collection of information on lifestyle risk factors using questionnaire 2) Risk estimation and stratification into risk groups based on questionnaire data and information from the electronic patient record (EPR) using validated risk estimation models, 3) An individual electronic health profile with personalized advise on lifestyle change and 4) targeted preventive services at the general practitioner (GP) or the municipality for citizens at risk of lifestyle disease and citizens with risk behavior, respectively.

The intervention is supported by a patient-centered health information system that facilitates informed patient action and integrates general practice and municipality health care providers.

Description:

Recruitment strategy:

The study is carried out in two municipalities in the Region of Southern Denmark (Haderslev and Varde municipality. Total number of inhabitants: 98.925). All general practitioners in the two municipalities (n=68) have been invited, and a total of 47 have agreed to participate in the study. A total of 200 citizens born 1957-1986 are selected from the patient list of each participating GP. Before selection, the citizens are stratified into households, and subsequently households are randomly selected until the total number of citizens per enrolled GP reaches 200. In selection of households the proportion of citizens living alone and the proportion of citizens living with one or more potential participants is taken into account. No disease-related criteria for excluding a citizen are defined prior to the study. The selected citizens are invited to participate and asked to sign a declaration of consent.

Risk stratification and preventive services offered:

Enrolled participants receive a 15-item questionnaire on lifestyle, familiar disposition of lifestyle disease and selected symptoms. From the individual electronic patient records (EPR) at the GP information on diagnoses and treatment of COPD, type-2 diabetes, hyperlipidemia, hypertension and ischemic heart disease are drawn. Based on questionnaire and EPR data the participants are stratified into four groups: 1) Citizens with an already diagnosed lifestyle related disease, 2) Citizens with an increased risk of lifestyle related disease, 3) Citizens with risk behavior and 4) Citizens with a healthy lifestyle.

Citizens in group 1 are already being treated and/or receive behavioral interventions and are therefore not the primary target of this study. Citizens in group 2 has a calculated increased risk of lifestyle related disease(s) based on validated predictive models for risk of COPD, type-2 diabetes and cardiovascular disease. The risk of COPD is calculated using the COPD-PS screener algorithm taking into account information on age, total cigarette consumption and respiratory symptoms. The risk of type-2 diabetes is calculated based on the algorithm used in the Addition study including information on age, gender, BMI, history of hypertension, physical activity and family history of diabetes. The cut-off value for being at risk of type-2 diabetes, and COPD follows the recommendations of the two models. The risk of cardiovascular disease is calculated using the Heart Score BMI score based on information about age, gender, smoking status and BMI. An increased risk of cardiovascular disease is defined in citizens with a ≥5% risk of dying of cardiovascular disease within the next 10 years. Citizens in group 2 are offered a preventive program at the GP including an initial health examination and subsequent behavior counselling. Citizens in group 3 are defined by having a BMI>35, being daily smoker, having a high risk alcohol consumption, having unhealthy eating habits and/or low physical activity. Evaluation of eating habits is based on the recommendations in the Swedish National Guidelines on Disease Prevention, and evaluation of alcohol consumption and physical activity is based on recommendations from the Danish Health Authority. Citizens in group 3 are offered behavior counselling in the municipality and community health services, if necessary. Citizens in group 4 are not offered any further services.

Electronic health information system:

The intervention is supported by a patient-centered health information system that facilitates informed patient action based on the predictive model for identification and stratification of citizens to the appropriate care providers and that supports the initiation and follow up of preventive care through the provision of health information resources, decision aids, risk calculators, personalized motivational messages and integrates primary care and municipality health care providers.

Common training course:

Before the study commences enrolled GPs, practice staff and health professionals from the municipalities are offered a common training course. The aim of the course is to train the specific intervention elements and to improve the inter-sectoral knowledge and collaboration on prevention of lifestyle diseases.

Evaluation:

Evaluation of the study will be carried out using quantitative as well as qualitative research methods. Details on evaluation methods are included in section 9.

Results of the present pilot study will be used for the adjustment of the intervention prior to a large scale study comprising 10 municipalities, up to 360 GPs and 200.000 citizens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9400
• Est. completion date: December 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 59 Years

Eligibility

Inclusion Criteria:

• Patients listed to one of the participating GPs

• Place of residence: One of the two participating municipalities in the Region of Southern Denmark.

• Year of birth: 1957-1986

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Type-2 Diabetes

Intervention

Behavioral:
• Lifestyle intervention
1) Systematic collection of information on lifestyle risk factors using questionnaire 2) Risk estimation and stratification into risk groups based on questionnaire data and information from the electronic patient record (EPR) using validated risk estimation models, 3) An individual electronic health profile with personalized advise on lifestyle change and 4) targeted preventive services incl. lifestyle counseling at the GP or the municipality for citizens at increased risk of lifestyle disease and citizens with risk behavior, respectively.

Locations

Country	Name	City	State
Denmark	Research Programme on Health Promotion and Prevention, National Institute of Public Health, University of Southern Denmark,	Copenhagen
Denmark	Center of Health Economics Research, Department of Business and Economics, University of Southern Denmark	Odense
Denmark	Department of Sports Science and Clinical Biomechanics, Musculoskeletal Function and Physiotherapy, University of Southern Denmark	Odense
Denmark	Research Unit of General Practice, Dept. of Public Health, University of Southern Denmark,	Odense C
Norway	Research Group for Information Systems, Department of Informatics, University of Oslo	Oslo
Sweden	Center for Primary Health Care Research, Department of Clinical Sciences	Malmø

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern Denmark	Lund University, University of Oslo

Countries where clinical trial is conducted

Denmark,  Norway,  Sweden, 

References & Publications (9)

Cardiology. ESo. Heartscore BMI score [Internet]. Available from: https://escol.escardio.org/heartscore/calc.aspx?model=europelow. 2014.

Christensen JO, Sandbaek A, Lauritzen T, Borch-Johnsen K. Population-based stepwise screening for unrecognised Type 2 diabetes is ineffective in general practice despite reliable algorithms. Diabetologia. 2004 Sep;47(9):1566-73. Epub 2004 Sep 8. — View Citation

Engelsen Cd, Koekkoek PS, Godefrooij MB, Spigt MG, Rutten GE. Screening for increased cardiometabolic risk in primary care: a systematic review. Br J Gen Pract. 2014 Oct;64(627):e616-26. doi: 10.3399/bjgp14X681781. — View Citation

James WP. The epidemiology of obesity: the size of the problem. J Intern Med. 2008 Apr;263(4):336-52. doi: 10.1111/j.1365-2796.2008.01922.x. Epub 2008 Feb 27. Review. — View Citation

King H, Aubert RE, Herman WH. Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care. 1998 Sep;21(9):1414-31. — View Citation

Martinez FJ, Raczek AE, Seifer FD, Conoscenti CS, Curtice TG, D'Eletto T, Cote C, Hawkins C, Phillips AL; COPD-PS Clinician Working Group. Development and initial validation of a self-scored COPD Population Screener Questionnaire (COPD-PS). COPD. 2008 Apr;5(2):85-95. doi: 10.1080/15412550801940721. — View Citation

Si S, Moss JR, Sullivan TR, Newton SS, Stocks NP. Effectiveness of general practice-based health checks: a systematic review and meta-analysis. Br J Gen Pract. 2014 Jan;64(618):e47-53. doi: 10.3399/bjgp14X676456. Review. — View Citation

Socialstyrelsen. S. Sjukdomsförebyggande metoder. Vetenskabeligt underlag för nationella riktlinjer. 2011

Yusuf S, Reddy S, Ounpuu S, Anand S. Global burden of cardiovascular diseases: part I: general considerations, the epidemiologic transition, risk factors, and impact of urbanization. Circulation. 2001 Nov 27;104(22):2746-53. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in proportion of citizens at increased risk of lifestyle related disease from baseline to the 12 weeks follow up	Questionnaire. Risk of lifestyle related disease is estimated based on the validated algorithms described under Detailed Study Description	At baseline and within 1 month following the 12 weeks study period.
Secondary	Evaluation of the patient centered health information system with focus on design, usability and effect of the decision support system.	Focus group interviews within three months before study start. The focus groups comprise 6 GPs and 2 practice staff members, 9 municipality staff members, 9 citizens and representatives from 6 stakeholder organizations, respectively.; Observational studies focusing on 6-8 citizens during the 12 weeks study period with focus on all situations where the health information system is used (at home, at the GPs, etc.).; Questionnaire to all participating citizens within 1 month following the 12 weeks study period and to all participating GPs and municipality staff members following each study related patient encounter.	Three months before the study period, ongoing during the 12 weeks study period and within one month following the 12 weeks study period, respectively.
Secondary	Process evaluation focusing on the intervention in general practice.	Observational studies during 10-15 behavior counseling sessions in different general practices, followed by qualitative interviews with the participating citizens, GPs and practice staff.; Questionnaire to all participating GPs and practice staff members following each study related patient encounter.	Ongoing during the 12 weeks study period
Secondary	Quality of Life Subscale on the Hip injury and Osteoarthritis Outcome Score (HOOS)/Knee Injury and Osteoarthritis Outcome Score (KOOS)	Participants replying "yes" to any of the osteoarthritis related questions on hip/knee pain, GP care seeking or surgery at baseline will receive additional questions on knee/hip related quality of life.	At baseline
Secondary	Patient enablement following the behavior counselling session at the GP.	Questionnaire incl. Patient Enablement Instrument (PEI)	Within one week following each behavior counselling session at the GP.
Secondary	Patient reported self-efficacy	Questionnaire incl. The General Self-Efficacy Scale	At baseline
Secondary	Patient reported mental well-being.	Questionnaire incl. The short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)	At baseline and within 1 month following the 12 weeks study period.
Secondary	Process evaluation focusing on the common training course for enrolled GPs, practice staff and health professionals from the municipalities.	Observational studies during the common training course and questionnaire at the end of the course.	The common training course before study start.
Secondary	GPs and the citizens preferences with regard to the content of the behavior counselling session, and change in preferences from baseline to the 12 weeks follow up.	Questionnaire using discrete choice modelling.	At baseline and within 1 month following the 12 weeks study period.
Secondary	Patients' perceptions of relational empathy following the behavior counselling session at the GP.	Questionnaire including The Consultation And Relational Empathy (CARE) measure.	Within one week following each behavior counselling session at the GP.
Secondary	Patient reported Meaning-Making and Health	Questionnaire with items sampled from the validated questionnaire SoMe (Sources of Meaning)	Within 1 month following the 12 weeks study period.
Secondary	Patient reported Spiritual Wellbeing	Questionnaire including the validated FACITSp scale	Within 1 month following the 12 weeks study period.
Secondary	Patient reported Religious belief and practices	Questionnaire with items sampled from the validated questionnaire European Value Study (EVS)	Within 1 month following the 12 weeks study period
Secondary	GP reported perceived importance of communication on existential and spiritual issues	Questionnaire with two tested items developed for this study	Within 1 month following the 12 weeks study period.
Secondary	GP reported Self-efficacy and barriers in communication on existential and spiritual issues	Questionnaire with items sampled from the validated Self-efficacy questionnaire	Within 1 month following the 12 weeks study period.
Secondary	GP reported Personal belief	Questionnaire with items sampled from the validated questionnaire European Value Study (EVS)	Within 1 month following the 12 weeks study period.