NCT01231256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
495

participants targeted

Target at P75+ for not_applicable quality-of-life

Timeline
Completed

Started Feb 1998

Longer than P75 for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1998

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2001

Completed
9 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2010

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

3.8 years

First QC Date

October 29, 2010

Last Update Submit

May 1, 2018

Conditions

Keywords

Quality of lifepreventive health consultationGeneral practiceresourceslife style

Outcome Measures

Primary Outcomes (1)

  • Quality of Life (SF12)

    Change in Quality of Life one year after preventive health consultation (Physical Component (PCS) and Mental Component score (MCS))

    one year after intervention

Secondary Outcomes (10)

  • Change in life style

    One year after intervention

  • Change in self evaluated Health

    one year after intervention

  • Fraction with goal-setting

    during the preventive health consultation

  • Change in problems with network

    one year after preventive health consultation

  • Change in resources

    one year after preventive health consultation

  • +5 more secondary outcomes

Study Arms (2)

preventive health consultation

EXPERIMENTAL

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

Control

NO INTERVENTION

Controls are not offered preventive health consultations, but had questionnaires as the intervention arm

Interventions

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.

Also known as: Consultation
preventive health consultation

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit for General Practice, University of Southern Denmark

Odense C, DK-5000, Denmark

Location

Related Publications (4)

  • Freund KS, Lous J. [Potentially marginalized 20-44-years-olds in general practice. Who are they? The results of a questionnaire screening]. Ugeskr Laeger. 2002 Nov 11;164(46):5367-72. Danish.

  • Freund KS, Lous J. The effect of preventive consultations on young adults with psychosocial problems: a randomized trial. Health Educ Res. 2012 Oct;27(5):927-45. doi: 10.1093/her/cys048. Epub 2012 Apr 2.

  • Hansen E, Fonager K, Freund KS, Lous J. The impact of non-responders on health and lifestyle outcomes in an intervention study. BMC Res Notes. 2014 Sep 11;7:632. doi: 10.1186/1756-0500-7-632.

  • Lous J, Freund KS. Predictors of weight loss in young adults who are over-weight or obese and have psychosocial problems: a post hoc analysis. BMC Fam Pract. 2016 Apr 11;17:43. doi: 10.1186/s12875-016-0437-8.

MeSH Terms

Interventions

Referral and Consultation

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Jørgen Lous, Prof, DMSc

    University of Southern Denmark

    STUDY DIRECTOR
  • Kirsten Freund, MD, GP

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 29, 2010

First Posted

November 1, 2010

Study Start

February 1, 1998

Primary Completion

November 1, 2001

Study Completion

December 1, 2015

Last Updated

May 2, 2018

Record last verified: 2018-05

Locations