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Preventive Health Consultations With Young Adults With Multiple Problems

This study has been terminated.
(Stopped as planned in 2001, follow up in 2010-11)
Sponsor:
Collaborators:
Region North Denmark
University of Aarhus
University of Copenhagen
Information provided by (Responsible Party):
Jørgen Lous, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01231256
First received: October 29, 2010
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Quality of Life
Life Style
Behavioral Research
 Behavioral: Preventive health consultation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Quality of Life (SF12) [ Time Frame: one year after intervention ] [ Designated as safety issue: No ]
    Change in Quality of Life one year after preventive health consultation (Physical Component (PCS) and Mental Component score (MCS))


Secondary Outcome Measures:
  • Change in life style [ Time Frame: One year after intervention ] [ Designated as safety issue: No ]
    Smoking, diet, exercise, weight loss, acohol use

  • Change in self evaluated Health [ Time Frame: one year after intervention ] [ Designated as safety issue: No ]
    Question about self evaluated health (on a five point scale)

  • Fraction with goal-setting [ Time Frame: during the preventive health consultation ] [ Designated as safety issue: No ]
    Fraction with one or two goal-settings during the preventive health consultation

  • Change in problems with network [ Time Frame: one year after preventive health consultation ] [ Designated as safety issue: No ]
    Problems with networking, four questions (from 0 to 4 problem-points each, total range 0 to 16 problem-points)

  • Change in resources [ Time Frame: one year after preventive health consultation ] [ Designated as safety issue: No ]
    Problems with resources five questions (from 0 to 4 problem-points each, total range 0 to 20 problem-points)

  • Change in social problems [ Time Frame: one year after preventive health consultation ] [ Designated as safety issue: No ]
    Social problems (i.e. unemployment, family problems, child problems, ect.). A total of 15 possible problems.

  • Written statements about own resources and barriers to obtain the chosen goal [ Time Frame: during the preventive health consultation ] [ Designated as safety issue: No ]
    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

  • Goals fulfilled after one year [ Time Frame: one year after preventive health consultation ] [ Designated as safety issue: No ]
    Fraction of goals fulfilled after one year - analyses in relation to goal, resources and barriers, and status at baseline

  • Cost of the intervention [ Time Frame: after one year ] [ Designated as safety issue: No ]
    Cost of the intervention seen in relation to outcomes

  • Side effects [ Time Frame: after one year ] [ Designated as safety issue: No ]
    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


Enrollment: 495
Study Start Date: February 1998
Estimated Study Completion Date: December 2013
Primary Completion Date: November 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231256

Locations
Denmark
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
Investigators
Study Director: Jørgen Lous, Prof, DMSc University of Southern Denmark
Principal Investigator: Kirsten Freund, MD, GP University of Southern Denmark
  More Information

Publications:

Responsible Party: Jørgen Lous, Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01231256     History of Changes
Other Study ID Numbers: VN97/177
Study First Received: October 29, 2010
Last Updated: January 7, 2013
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Southern Denmark:
Quality of life
preventive health consultation
General practice
resources
life style

ClinicalTrials.gov processed this record on May 19, 2013