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Feasibility of a Preventive Program Against Lifestyle Related Diseases

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ClinicalTrials.gov Identifier: NCT02797392
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : April 29, 2019
Sponsor:
Collaborators:
University of Oslo
Lund University
Information provided by (Responsible Party):
Trine Thilsing, University of Southern Denmark

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.


Condition or disease Intervention/treatment Phase
Type-2 Diabetes Cardiovascular Diseases Chronic Obstructive Pulmonary Disease (COPD) Behavioral: Lifestyle intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Early Detection and Prevention of Lifestyle Related Diseases - a Pilot Study
Actual Study Start Date : September 2016
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lifestyle intervention
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
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.




Primary Outcome Measures :
  1. Change in proportion of citizens at increased risk of lifestyle related disease from baseline to the 12 weeks follow up [ Time Frame: At baseline and within 1 month following the 12 weeks study period. ]
    Questionnaire. Risk of lifestyle related disease is estimated based on the validated algorithms described under Detailed Study Description


Secondary Outcome Measures :
  1. Evaluation of the patient centered health information system with focus on design, usability and effect of the decision support system. [ Time Frame: Three months before the study period, ongoing during the 12 weeks study period and within one month following the 12 weeks study period, respectively. ]

    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.


  2. Process evaluation focusing on the intervention in general practice. [ Time Frame: Ongoing during the 12 weeks study period ]

    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.


  3. Quality of Life Subscale on the Hip injury and Osteoarthritis Outcome Score (HOOS)/Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: At baseline ]
    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.

  4. Patient enablement following the behavior counselling session at the GP. [ Time Frame: Within one week following each behavior counselling session at the GP. ]
    Questionnaire incl. Patient Enablement Instrument (PEI)

  5. Patient reported self-efficacy [ Time Frame: At baseline ]
    Questionnaire incl. The General Self-Efficacy Scale

  6. Patient reported mental well-being. [ Time Frame: At baseline and within 1 month following the 12 weeks study period. ]
    Questionnaire incl. The short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)

  7. Process evaluation focusing on the common training course for enrolled GPs, practice staff and health professionals from the municipalities. [ Time Frame: The common training course before study start. ]
    Observational studies during the common training course and questionnaire at the end of the course.

  8. 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. [ Time Frame: At baseline and within 1 month following the 12 weeks study period. ]
    Questionnaire using discrete choice modelling.

  9. Patients' perceptions of relational empathy following the behavior counselling session at the GP. [ Time Frame: Within one week following each behavior counselling session at the GP. ]
    Questionnaire including The Consultation And Relational Empathy (CARE) measure.

  10. Patient reported Meaning-Making and Health [ Time Frame: Within 1 month following the 12 weeks study period. ]
    Questionnaire with items sampled from the validated questionnaire SoMe (Sources of Meaning)

  11. Patient reported Spiritual Wellbeing [ Time Frame: Within 1 month following the 12 weeks study period. ]
    Questionnaire including the validated FACITSp scale

  12. Patient reported Religious belief and practices [ Time Frame: Within 1 month following the 12 weeks study period ]
    Questionnaire with items sampled from the validated questionnaire European Value Study (EVS)

  13. GP reported perceived importance of communication on existential and spiritual issues [ Time Frame: Within 1 month following the 12 weeks study period. ]
    Questionnaire with two tested items developed for this study

  14. GP reported Self-efficacy and barriers in communication on existential and spiritual issues [ Time Frame: Within 1 month following the 12 weeks study period. ]
    Questionnaire with items sampled from the validated Self-efficacy questionnaire

  15. GP reported Personal belief [ Time Frame: Within 1 month following the 12 weeks study period. ]
    Questionnaire with items sampled from the validated questionnaire European Value Study (EVS)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797392


Locations
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Denmark
Research Programme on Health Promotion and Prevention, National Institute of Public Health, University of Southern Denmark,
Copenhagen, Denmark, DK-1353
Research Unit of General Practice, Dept. of Public Health, University of Southern Denmark,
Odense C, Denmark, DK-5000
Center of Health Economics Research, Department of Business and Economics, University of Southern Denmark
Odense, Denmark, DK-5230
Department of Sports Science and Clinical Biomechanics, Musculoskeletal Function and Physiotherapy, University of Southern Denmark
Odense, Denmark, DK-5230
Norway
Research Group for Information Systems, Department of Informatics, University of Oslo
Oslo, Norway, 0373
Sweden
Center for Primary Health Care Research, Department of Clinical Sciences
Malmø, Sweden, SE-205 02
Sponsors and Collaborators
University of Southern Denmark
University of Oslo
Lund University
Investigators
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Principal Investigator: Jens Søndergaard Research Unit of General Practice, Dept. of Public Health, University of Southern Denmark, DK-5000 Odense C, Denmark

Publications:
Cardiology. ESo. Heartscore BMI score [Internet]. Available from: https://escol.escardio.org/heartscore/calc.aspx?model=europelow. 2014.
Socialstyrelsen. S. Sjukdomsförebyggande metoder. Vetenskabeligt underlag för nationella riktlinjer. 2011

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Trine Thilsing, Postdoc, research coordinator, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT02797392     History of Changes
Other Study ID Numbers: TOFpilot2016
11/13244 ( Other Grant/Funding Number: Region of Southern Denmark )
15/10562 ( Other Grant/Funding Number: Comm. of Qual. & Educ. in Gen. Pract., Reg.of South.Denm. )
14/43732. ( Other Grant/Funding Number: Comm. of Qual. & Educ. in Gen. Pract., Reg.of South.Denm. )
2015-57-0008 ( Registry Identifier: The Danish Data Protection Agency )
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Trine Thilsing, University of Southern Denmark:
Tailored lifestyle intervention
Selective prevention
Primary care
Web based health risk assessment
Patient-centered health information system
Lifestyle intervention
preventive treatment
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases