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Preventive Health Consultations With Young Adults With Multiple Problems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01231256
Recruitment Status : Completed
First Posted : November 1, 2010
Last Update Posted : May 2, 2018
Region North Denmark
University of Aarhus
University of Copenhagen
Information provided by (Responsible Party):
Jørgen Lous, University of Southern Denmark

Brief Summary:

A new working method, i.e. a questionnaire completed at home followed by a patient-centred preventive health consultation with follow-up, can be used by all general practitioners (GPs) as a preventive offer to their patients with multiple problems in lifestyle, well-being or health behaviour, if this project is shown to be effective.

The investigators use a broad preventive offer in a structured way to young adults with multiple psychosocial problems (a certain risk profile) found by a screening questionnaire when arriving to the clinic.

The main hypothesis of the project is:

By using the questionnaire and subsequent patient-centred health consultation the GP is able to support the participants to improve their resources, their well-being and self-estimated health. Subsequently, relevant changes in health habits and life situation might be initiated in order to prevent or reduce future problems or illness.

Condition or disease Intervention/treatment Phase
Quality of Life Life Style Behavioral: Preventive health consultation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 495 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Study on Preventive Health Consultations in General Practice With Young Adults With Multiple Problems; a Randomised Controlled Study
Study Start Date : February 1998
Actual Primary Completion Date : November 2001
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: preventive health consultation
Half participants randomized to a one hour preventive health consultation with their own general practitioner and a follow up consultation 3 months later
Behavioral: Preventive health consultation
A one hour preventive health consultation, based on completed baseline questionnaire, with one or two goal setting for a better life during the next year, with discussion and registration of resources, barriers, and time scheme. And a 3 month follow up consultation.
Other Name: Consultation

No Intervention: Control
Controls are not offered preventive health consultations, but had questionnaires as the intervention arm

Primary Outcome Measures :
  1. Quality of Life (SF12) [ Time Frame: one year after intervention ]
    Change in Quality of Life one year after preventive health consultation (Physical Component (PCS) and Mental Component score (MCS))

Secondary Outcome Measures :
  1. Change in life style [ Time Frame: One year after intervention ]
    Smoking, diet, exercise, weight loss, acohol use

  2. Change in self evaluated Health [ Time Frame: one year after intervention ]
    Question about self evaluated health (on a five point scale)

  3. Fraction with goal-setting [ Time Frame: during the preventive health consultation ]
    Fraction with one or two goal-settings during the preventive health consultation

  4. Change in problems with network [ Time Frame: one year after preventive health consultation ]
    Problems with networking, four questions (from 0 to 4 problem-points each, total range 0 to 16 problem-points)

  5. Change in resources [ Time Frame: one year after preventive health consultation ]
    Problems with resources five questions (from 0 to 4 problem-points each, total range 0 to 20 problem-points)

  6. Change in social problems [ Time Frame: one year after preventive health consultation ]
    Social problems (i.e. unemployment, family problems, child problems, ect.). A total of 15 possible problems.

  7. Written statements about own resources and barriers to obtain the chosen goal [ Time Frame: during the preventive health consultation ]
    Quantitative and qualitative analysis of participants written statements about own resources and barrieres at the preventive health consultation and at follow up consultation after 3 months

  8. Goals fulfilled after one year [ Time Frame: one year after preventive health consultation ]
    Fraction of goals fulfilled after one year - analyses in relation to goal, resources and barriers, and status at baseline

  9. Cost of the intervention [ Time Frame: after one year ]
    Cost of the intervention seen in relation to outcomes

  10. Side effects [ Time Frame: after one year ]
    Registration of any side effects or harm during the study or in the questionnaires. Written statements by participants at one year follow-up, and by the GPs

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients coming to the clinic
  • having multiple problems (the quartile with most problems)

Exclusion Criteria:

  • Do not want to participate
  • Do not understand Danish well enough to complete the questionnaires
  • Have too few problems
  • Have severe psychiatric disease

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 identifier (NCT number): NCT01231256

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Research Unit for General Practice, University of Southern Denmark
Odense C, Denmark, DK-5000
Sponsors and Collaborators
University of Southern Denmark
Region North Denmark
University of Aarhus
University of Copenhagen
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Study Director: Jørgen Lous, Prof, DMSc University of Southern Denmark
Principal Investigator: Kirsten Freund, MD, GP University of Southern Denmark
Publications of Results:
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Responsible Party: Jørgen Lous, Professor, University of Southern Denmark Identifier: NCT01231256    
Other Study ID Numbers: VN97/177
First Posted: November 1, 2010    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Keywords provided by Jørgen Lous, University of Southern Denmark:
Quality of life
preventive health consultation
General practice
life style