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Quality of LifeNCT01231256

Preventive Health Consultations With Young Adults With Multiple Problems

A study testing Preventive health consultation in people with Quality of Life and Life Style, run by University of Southern Denmark at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 45 years
Conditions the study is for
Quality of Life, Life Style
What is being tested?
Preventive health consultation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
495 participants
Where
1 siteDenmark
Study dates
Feb 1998to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Research Unit for General Practice, University of Southern Denmark

    Odense C, DK-5000

Other trials in Denmark

About this study

Official title: A Study on Preventive Health Consultations in General Practice With Young Adults With Multiple Problems; a Randomised Controlled Study

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.

Read more

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.

Read the detailed description

The main hypothesis of the project is:

By using the questionnaire and subsequent patient-centred health consultation the GP is able to contribute to improve the resources of the participants, 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.

The investigators want to test this hypothesis by describing

  • the participating patients' situation at baseline (resources and problems), and after one year
  • the content of the health interview (goals, resources and barriers for change)
  • measure change of lifestyle and living conditions
  • to evaluate the economic costs of the intervention
  • evaluation of positive and negative effect of the health consultations for the patient and the GP

Partial hypothesis 1:

A large part of the target group experience many strains and have difficulties in fulfilling their personal expectations to a normal everyday life. Some might have risk behaviour.

The object of the project is to answer the following questions:

  1. How is the baseline status of the participants (seven or more risk points) regarding self-estimated health, resources, family situation and risk score compared with the non-participants? (Paper 1)
  2. Does the health consultation and follow-up consultation have effect within a year?
  3. Initiate request for a change in behaviour within lifestyle and living conditions
  4. Support a possible request for change by choosing one or two goals, as to somatic, mental and social issues
  5. Contribute to an actual change in lifestyle and living conditions, in particular as regards to work, tobacco, alcohol, diet/weight and exercise
  6. Contribute to a better self-estimated health
  7. Contribute to improving resources.

Partial hypothesis 2:

The GP will in the project use a new working method that enables general impression and support of the individual's resources, which is very unlike the daily consultation, where the main focus is on risk thinking.

Does the registration by the GP and the patient reflect focus on improving resources?

  1. Registration of resources and barriers to obtain the goals
  2. Registration of time aspect to obtain these
  3. Registration of need for further intervention (by GP or by others)

Partial hypothesis 3:

It has an effect to teach the GPs patient-centred preventive health consultation at short seminars/courses with focus on behavioural psychology, psychosocial medicine, and lifestyle issues such as tobacco, alcohol, drug abuse, diet / weight and exercise.

  1. Have the GPs changed their view on preventive health consultations during the project period?
  2. Have the GPs changed their view of changing potentials of their patients because of their participation in the study?

Method

Inclusion criteria for patients:

The practice secretary invites the patients to participate in the research project by asking all patients between 20-44 years coming to the clinic on a specific day or two in each month to complete a preliminary questionnaire (Screening questionnaire, SQ) asking 33 questions about lifestyle, resources, social situation and child problems. The quartile with most problems is invited to participate in the randomized trial. When five patients are included, no more patients are screened that day. The included patients receive a questionnaire (baseline questionnaire, BQ) of 23 pages they have to complete at home and return to the clinic as basis for the evaluation, the health consultation, and as a priming tool for the patient before the preventive health consultation.

Design The study is a randomized, controlled trial (RCT) with intervention (questionnaires and patient-centred preventive health consultations) compared with controls (questionnaires without health consultation). The intervention consisting of two consultations: the first of 60 minutes duration and follow-up of 20 minutes after three months. Both groups had postal follow-up questionnaires after one year.

Content of consultations is chosen by the patients, based on their completed questionnaires and own ideas of main problems, wishes and ability to improve their living conditions, health and quality of life guided and supported by the GP.

A follow-up after 3, 5 and 10 years is possible. Max 50 GPs can participate in the project with each max 20 health interviews (including a follow-up within three months) per year. That means approximately two interviews every month.

The inclusion period is expected to be about 1½ year from February 1998 to September 1999. A maximum of 1000 persons in the intervention group and 1000 in the control group can be included.

Randomisation When the BQ is returned to the clinic, the secretary makes a telephone block randomisation by phoning the project secretary, where every GP has a randomisation scheme with 40 computer-generated random numbers: 20 even numbers and 20 odd numbers to tick off in order when used. Patients hitting an even number will be offered a health interview, whereas patients with odd numbers will have to settle for the inspiration of the questionnaire and the regular visits to the GP. Both groups will be included in the follow-up schedule after a year, and possibly after 3, 5 and 10 years.

Inclusion criteria for GPs All 325 GPs in the county will be invited to a weekend course and offered the possibility to attend the project. If more than 50 GPs have registered for the project, the county is able to close for more registrations. The project team will organize and implement relevant courses. Firstly, all the county's GPs are invited to a course on 16 -17 January 1998 or 27-28/3-98 where senior school psychologist Per Kjeldsen, Aalborg, and clinical psychologist Annette Winter, Aarhus will teach and provide assignments based on different theories and behavioural problems. The project will be presented. Jens Tølbøll-Mortensen will teach about occupational medicine. Some meetings on factual knowledge about alcohol abuse, tobacco, the dietary importance, and cardiovascular diseases will be held. Furthermore, there will be follow-up courses during the project period about psychosocial preventive aspects on health and illness behaviour and the "health fraction".

Power calculation With a minimal relevant difference in Quality of life (SF12) of 3 (for example 47 and 50, and SD=10) and a type 1 error (alfa) of 0.05 and a type two error (1-beta) of 0.80, meaning that the investigators need 178 persons in each group.

Material A. The Screening questionnaire, SQ, consists of 33 problem questions within three main fields: family/social situation, resources and lifestyle. Most of the questions used are taken from different questionnaires used in other national and international studies, and some are constructed by KSF in accordance with psychosocial literature and 25 years experience as a GP. The number of problems is decisive for whether the patient will be included in the project or not. The quartile with most problems could be included. Some of the questions were binary and some had a five-graded answer category, where the three worst categories were defined as having a problem. After pilot-testing in four clinics the inclusion criteria were seven or more problems.

  1. Baseline questionnaire, BQ consists of about 80 questions about family situation, resources, work, education, quality of life, health, disease and health behaviour, consumption of food, medicine, tobacco, alcohol and drugs. The BQ was based on the Danish population health and illness statistics every five years (Danish Institute of Clinical Epidemiology, DIKE), international studies, and a former study on preventive health consultations in Region North, Denmark. The 23-page questionnaire is to be completed by the patient at home.
  2. In the last part of the health consultation the patient and the GP have to complete the dialogue chart (DC1), together, evaluating the health consultation's objectives, the patient's goals, and patient's resources, barriers and time needed to obtain these goals.
  3. After the 3-month follow-up a similar DC2 was completed. E. A GP's evaluation form completed by the GP before and after the study. F. An intermediate telephone interview of the participating GPs by KSF. G. A one-year follow-up questionnaire, OQ is almost identical to the BQ questionnaire, but added a few final questions. The OQ questionnaire was mailed to both groups and completed at home, and returned to the project secretary by post.

Intervention elements

  1. Courses for the GPs.
  2. Questionnaires to the patients (interventions and controls). 2a. Screening questionnaire (SQ). 2b. Baseline questionnaire (BQ). 2c. One year questionnaire (OQ).
  3. Health consultations with dialogue chart (DC1 and DC2).
  4. Questionnaire and telephone interview with the GPs.

Financial support:

Department of Quality development, County of North Jutland, Lundbeck foundation, Fond for financing research in general practice and the health system in Denmark, PLU-foundation, Health Insurance Foundation, Sara Krabbes Legacy, University of Aarhus, University of Southern Denmark, University of Copenhagen,

Being tested
Preventive health consultation
Keywords
Quality of life, preventive health consultation, General practice, resources, life style

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preventive health consultationBehavioural

    Also called 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.

Study groups in NCT01231256
Study groupRoleWhat they receive
preventive health consultationExperimentalHalf participants randomized to a one hour preventive health consultation with their own general practitioner and a follow up consultation 3 months later
Receives: Behavioral: Preventive health consultation
ControlNo interventionControls are not offered preventive health consultations, but had questionnaires as the intervention arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Life (SF12)

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

    Measured: one year after intervention

Secondary outcomes (10)
  1. Change in life style

    Smoking, diet, exercise, weight loss, acohol use

    Measured: One year after intervention

  2. Change in self evaluated Health

    Question about self evaluated health (on a five point scale)

    Measured: one year after intervention

  3. Fraction with goal-setting

    Fraction with one or two goal-settings during the preventive health consultation

    Measured: during the preventive health consultation

  4. Change in problems with network

    Problems with networking, four questions (from 0 to 4 problem-points each, total range 0 to 16 problem-points)

    Measured: one year after preventive health consultation

  5. Change in resources

    Problems with resources five questions (from 0 to 4 problem-points each, total range 0 to 20 problem-points)

    Measured: one year after preventive health consultation

  6. Change in social problems

    Social problems (i.e. unemployment, family problems, child problems, ect.). A total of 15 possible problems.

    Measured: one year after preventive health consultation

  7. Written statements about own resources and barriers to obtain the chosen goal

    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

    Measured: during the preventive health consultation

  8. Goals fulfilled after one year

    Fraction of goals fulfilled after one year - analyses in relation to goal, resources and barriers, and status at baseline

    Measured: one year after preventive health consultation

  9. Cost of the intervention

    Cost of the intervention seen in relation to outcomes

    Measured: after one year

  10. Side effects

    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

    Measured: after one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2010 (estimated)
  2. Study startFeb 1998
  3. Primary completionNov 2001
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
495 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01231256
Sponsor's protocol ID
VN97/177
Status last verified
May 2018
First submitted
29 Oct 2010
Last updated
2 May 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12469380
  • 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.

    PubMed 22473217
  • 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.

    PubMed 25213806
  • 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.

    PubMed 27068690

Questions about this trial

What is this clinical trial studying?

A study testing Preventive health consultation in people with Quality of Life and Life Style, run by University of Southern Denmark at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life (SF12) (time frame: one year after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01231256, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.

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