Clinical trial NCT02797392: Feasibility of a Preventive Program Against Lifestyle Related Diseases
Official title: Early Detection and Prevention of Lifestyle Related Diseases - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type-2 Diabetes
Cardiovascular Diseases
Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Tailored lifestyle intervention
Selective prevention
Primary care
Web based health risk assessment
Patient-centered health information system
Lifestyle intervention
preventive treatment
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Lund University
First posted: 2016-06-13
Enrollment: 9400
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in proportion of citizens at increased risk of lifestyle related disease from baseline to the 12 weeks follow up
timeFrame: At baseline and within 1 month following the 12 weeks study period.
Secondary outcomes:
measure: Evaluation of the patient centered health information system with focus on design, usability and effect of the decision support system.
timeFrame: Three months before the study period, ongoing during the 12 weeks study period and within one month following the 12 weeks study period, respectively.
measure: Process evaluation focusing on the intervention in general practice.
timeFrame: Ongoing during the 12 weeks study period
measure: Quality of Life Subscale on the Hip injury and Osteoarthritis Outcome Score (HOOS)/Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: At baseline
measure: Patient enablement following the behavior counselling session at the GP.
timeFrame: Within one week following each behavior counselling session at the GP.
measure: Patient reported self-efficacy
timeFrame: At baseline
measure: Patient reported mental well-being.
timeFrame: At baseline and within 1 month following the 12 weeks study period.
measure: Process evaluation focusing on the common training course for enrolled GPs, practice staff and health professionals from the municipalities.
timeFrame: The common training course before study start.
measure: 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.
timeFrame: At baseline and within 1 month following the 12 weeks study period.
measure: Patients' perceptions of relational empathy following the behavior counselling session at the GP.
timeFrame: Within one week following each behavior counselling session at the GP.
measure: Patient reported Meaning-Making and Health
timeFrame: Within 1 month following the 12 weeks study period.
measure: Patient reported Spiritual Wellbeing
timeFrame: Within 1 month following the 12 weeks study period.
measure: Patient reported Religious belief and practices
timeFrame: Within 1 month following the 12 weeks study period
measure: GP reported perceived importance of communication on existential and spiritual issues
timeFrame: Within 1 month following the 12 weeks study period.
measure: GP reported Self-efficacy and barriers in communication on existential and spiritual issues
timeFrame: Within 1 month following the 12 weeks study period.
measure: GP reported Personal belief
timeFrame: Within 1 month following the 12 weeks study period.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Research Programme on Health Promotion and Prevention, National Institute of Public Health, University of Southern Denmark,
city: Odense C
country: Denmark
facility: Research Unit of General Practice, Dept. of Public Health, University of Southern Denmark,
city: Odense
country: Denmark
facility: Center of Health Economics Research, Department of Business and Economics, University of Southern Denmark
city: Odense
country: Denmark
facility: Department of Sports Science and Clinical Biomechanics, Musculoskeletal Function and Physiotherapy, University of Southern Denmark
city: Oslo
country: Norway
facility: Research Group for Information Systems, Department of Informatics, University of Oslo
city: Malmø
country: Sweden
facility: Center for Primary Health Care Research, Department of Clinical Sciences
Study officials:
affiliation: Research Unit of General Practice, Dept. of Public Health, University of Southern Denmark, DK-5000 Odense C, Denmark
name: Jens Søndergaard
role: PRINCIPAL_INVESTIGATOR
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