Feasibility of a Preventive Program Against Lifestyle Related Diseases

NCT02797392 | Completed DMC

• 5 other identifiers: TOFpilot201611/1324415/1056214/43732.2015-57-0008
• Study Type: interventional
• Target: 9,400
• Locations: 3 countries
• Sites: 6

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Evaluation of the patient centered health information system with focus on design, usability and effect of the decision support system.

  Three months before the study period, ongoing during the 12 weeks study period and within one month following the 12 weeks study period, respectively.

• Process evaluation focusing on the intervention in general practice.

  Ongoing during the 12 weeks study period

• Quality of Life Subscale on the Hip injury and Osteoarthritis Outcome Score (HOOS)/Knee Injury and Osteoarthritis Outcome Score (KOOS)

  At baseline

• Patient enablement following the behavior counselling session at the GP.

  Within one week following each behavior counselling session at the GP.

• Patient reported self-efficacy

  At baseline

Study Arms (1)

Lifestyle intervention

EXPERIMENTAL

All included citizens receive a questionnaire to estimate risk of disease and risk behavior. Information about lifestyle is collated with existing Electronic Patient Record (EPR) data and the citizen's risk of lifestyle-related disease is estimated based on validated algorithms for risk of type-2 diabetes, cardiovascular disease and COPD (Stratification). All citizens receive an electronic health profile and targeted advice. Citizens at increased risk of disease are offered a preventive program at the GP including an initial health examination and subsequent lifestyle counselling. Citizens with risk behavior are offered lifestyle counselling in the municipality and community health services, if necessary. Citizens diagnosed with a lifestyle related disease are already being treated by the GP, and therefore, like citizens with a healthy lifestyle, they are not offered any further services.

Behavioral: Lifestyle intervention

Interventions

Lifestyle intervention BEHAVIORAL

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.

Lifestyle intervention

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Southern Denmark: lead
• University of Oslo: collaborator
• Lund University: collaborator

Study Sites (6)

Research Programme on Health Promotion and Prevention, National Institute of Public Health, University of Southern Denmark,

Copenhagen, DK-1353, Denmark

Location

Center of Health Economics Research, Department of Business and Economics, University of Southern Denmark

Odense, DK-5230, Denmark

Location

Department of Sports Science and Clinical Biomechanics, Musculoskeletal Function and Physiotherapy, University of Southern Denmark

Odense, DK-5230, Denmark

Location

Research Unit of General Practice, Dept. of Public Health, University of Southern Denmark,

Odense C, DK-5000, Denmark

Location

Research Group for Information Systems, Department of Informatics, University of Oslo

Oslo, 0373, Norway

Location

Center for Primary Health Care Research, Department of Clinical Sciences

Malmo, SE-205 02, Sweden

Location

Related Publications (14)

• 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.

  PMID: 18312311 BACKGROUND

• 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. doi: 10.2337/diacare.21.9.1414.

  PMID: 9727886 BACKGROUND

• 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. doi: 10.1161/hc4601.099487.

  PMID: 11723030 BACKGROUND

• 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.

  PMID: 24567582 BACKGROUND

• 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.

  PMID: 25267047 BACKGROUND

• 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.

  PMID: 18415807 BACKGROUND

• 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. doi: 10.1007/s00125-004-1496-2. Epub 2004 Sep 8.

  PMID: 15365615 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• Leick C, Larsen LB, Larrabee Sonderlund A, Svensson NH, Sondergaard J, Thilsing T. Non-participation in a targeted prevention program aimed at lifestyle-related diseases: a questionnaire-based assessment of patient-reported reasons. BMC Public Health. 2022 May 13;22(1):970. doi: 10.1186/s12889-022-13382-8.

  PMID: 35562735 DERIVED

• Hansen CB, Pavlovic KMH, Sondergaard J, Thilsing T. Does GP empathy influence patient enablement and success in lifestyle change among high risk patients? BMC Fam Pract. 2020 Aug 8;21(1):159. doi: 10.1186/s12875-020-01232-8.

  PMID: 32770946 DERIVED

• Thilsing T, Sonderlund AL, Sondergaard J, Svensson NH, Christensen JR, Thomsen JL, Hvidt NC, Larsen LB. Changes in Health-Risk Behavior, Body Mass Index, Mental Well-Being, and Risk Status Following Participation in a Stepwise Web-Based and Face-to-Face Intervention for Prevention of Lifestyle-Related Diseases: Nonrandomized Follow-Up Cohort Study. JMIR Public Health Surveill. 2020 Jul 9;6(3):e16083. doi: 10.2196/16083.

  PMID: 32673269 DERIVED

• Larsen LB, Thilsing T, Pedersen LB. Patient preferences for preventive health checks in Danish general practice: a discrete choice experiment among patients at high risk of noncommunicable diseases. Fam Pract. 2020 Oct 19;37(5):689-694. doi: 10.1093/fampra/cmaa038.

  PMID: 32311022 DERIVED

• van Tunen JAC, Peat G, Bricca A, Larsen LB, Sondergaard J, Thilsing T, Roos EM, Thorlund JB. Association of osteoarthritis risk factors with knee and hip pain in a population-based sample of 29-59 year olds in Denmark: a cross-sectional analysis. BMC Musculoskelet Disord. 2018 Aug 21;19(1):300. doi: 10.1186/s12891-018-2183-7.

  PMID: 30126395 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jens Søndergaard

  Research Unit of General Practice, Dept. of Public Health, University of Southern Denmark, DK-5000 Odense C, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoc, research coordinator

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: June 13, 2016
• Study Start: September 1, 2016
• Primary Completion: February 28, 2017
• Study Completion: December 1, 2017
• Last Updated: April 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); SE (1); DK (4)