Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000142033
Ethics application status
Approved
Date submitted
9/11/2009
Date registered
12/02/2010
Date last updated
5/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development of youth friendly family medicine services in Bosnia and Herzegovina: a cluster randomized controlled trial
Scientific title
Transforming family medicine services into youth friendly services: a cluster randomised controlled trial evaluating family medicine team training and organisational restructuring in Bosnia and Herzegovina
Secondary ID [1] 280070 0
nil known
Universal Trial Number (UTN)
U1111-1112-4542
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Youth friendly health services 252157 0
Condition category
Condition code
Public Health 252357 252357 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
training of the family medicine team and organisational changes in the family medicine services in order to transform them into youth friendly health services. Family medicine teams in the intervention arm will attend two one-day training sessions at 3 months interval and complete assignments between the two training sessions. Training will take place in interactive sessions involving 10 teams at a time. Three trainers experienced in adolescent medicine and family medicine will provide the training.
Intervention code [1] 241524 0
Other interventions
Comparator / control treatment
Usual continuous medical education (CME) program and no organisational changes in the control family medicine services, wait list design. The CME program in Bosnia & Herzegovina does not usually include modules in adolescent health but the theme may be presented in lectures in paediatrics, which the family medicine are welcome to attend if they wish. There is no specific duration for the CME program but family doctors are required to acquire a certain number of points each year by attending lectures and training sessions
Control group
Active

Outcomes
Primary outcome [1] 253231 0
improved scores on the "Youth Friendly Health Services-World Health Organization Plus" (YFHS-WHO+) questionnaire, a validated questionnaire measuring youth friendliness in family medicine services
Timepoint [1] 253231 0
at baseline and 3-4 months post intervention
Secondary outcome [1] 262186 0
proportion of young people between the ages of 15 and 24 years consulting in these family medicine services, as extracted from the daily electronic list of patients consulting the service
Timepoint [1] 262186 0
at baseline and 6 months post intervention
Secondary outcome [2] 263250 0
proportion of young people between the ages of 10 and 14 years consulting in these family medicine services, as extracted from the daily electronic list of patients consulting the service. This will also be assessed as we expect the intervention to have effects on the consulting behaviour of younger adolescents as well.
Timepoint [2] 263250 0
at baseline and 6 months post intervention

Eligibility
Key inclusion criteria
Young people (15-24 years) consulting in participating family medicine services.
Only young people from the age of 15 years will be included for the evaluation of the services, although the aim is to provide services that are friendly also to younger adolescents. From the age of 15, young people are considered mature enough to provide consent on their own for participation in the study. The YFHS-WHO+ has been validated for completion by young people aged 15 years and older
Minimum age
15 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
acute illness or injury requiring immediate attention of the physician, severe mental disorder such as psychosis or suicidal thoughts requiring treatment in a specialised setting, intellectual disability, inability to understand questions in the language of Bosnia & Herzegovina.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Family medicine services from 10 municipalities in the region of Zenica in Bosnia & Herzegovina will participate in the study. The unit of randomisation will be the municipalities. Patients will be recruited in the participating practices to complete the YFHS-WHO+ questionnaire shortly after their consultation. They will be blind to intervention allocation. The services however will not be blind to their allocation as they will be participating in specific CME activities as part of the intervention. Allocation involved contacting a stastician not involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated stratified sequence (stratified by size of municipality, large and small) by a statistician not involed in the study
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
cluster randomized trial with municipalities as the unit of randomization, family medicine services as targets for the intervention and patients as subjects to measure the outcomes of the intervention
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2009
Actual
2/12/2009
Date of last participant enrolment
Anticipated
Actual
15/12/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment outside Australia
Country [1] 2320 0
Bosnia and Herzegovina
State/province [1] 2320 0
Zenica canton

Funding & Sponsors
Funding source category [1] 243998 0
Hospital
Name [1] 243998 0
Geneva University Hospitals
Country [1] 243998 0
Switzerland
Primary sponsor type
University
Name
University of Geneva
Address
Dr Dagmar Haller
4 rue Gabrielle-Perret-Gentil
1211 GENEVE 14
Country
Switzerland
Secondary sponsor category [1] 251349 0
Charities/Societies/Foundations
Name [1] 251349 0
Foundation fami
Address [1] 251349 0
Dr Dejan Sredic
Nemanjina 18, 74000 Doboj
Country [1] 251349 0
Bosnia and Herzegovina
Secondary sponsor category [2] 251350 0
Government body
Name [2] 251350 0
Public Health Institute
Address [2] 251350 0
Doboj-Zenica canton
74000 Doboj
Country [2] 251350 0
Bosnia and Herzegovina
Other collaborator category [1] 952 0
University
Name [1] 952 0
The University of Melbourne
Address [1] 952 0
Dr Lena Sanci
Department of General Practice,
200 Berkeley Street
Carlton 3053
Victoria
Country [1] 952 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244103 0
Comite departemental d'ethique de medecine interne et medecine communautaire, HUG
Ethics committee address [1] 244103 0
Ethics committee country [1] 244103 0
Switzerland
Date submitted for ethics approval [1] 244103 0
25/08/2009
Approval date [1] 244103 0
14/10/2009
Ethics approval number [1] 244103 0
protocole 09-199

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30483 0
Dr Dagmar M Haller
Address 30483 0
Primary Care Unit, Geneva University
9 avenue de Champel, 1211 GENEVE
Country 30483 0
Switzerland
Phone 30483 0
+41 22 372 96 79
Fax 30483 0
Email 30483 0
[email protected]
Contact person for public queries
Name 13730 0
Dagmar M Haller
Address 13730 0
Primary Care Unit, Geneva University
9 avenue de Champel, 1211 GENEVE
Country 13730 0
Switzerland
Phone 13730 0
+41 22 372 96 79
Fax 13730 0
+41 22 372 96 00
Email 13730 0
[email protected]
Contact person for scientific queries
Name 4658 0
Dagmar M Haller
Address 4658 0
Primary Care Unit, Geneva University
9 avenue de Champel, 1211 GENEVE
Country 4658 0
Switzerland
Phone 4658 0
+41 22 372 96 79
Fax 4658 0
+41 22 372 96 00
Email 4658 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.