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Trial registered on ANZCTR


Registration number
ACTRN12608000642381
Ethics application status
Approved
Date submitted
13/10/2008
Date registered
17/12/2008
Date last updated
4/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Communication of genetic information in families: A randomised trial of a genetic counselling intervention.
Scientific title
In individuals where there has been a new diagnosis of a genetic condition that has implications for family members, does enhanced genetic counselling compared with usual genetic counselling increase attendance at genetics services by their family members within 18 months of inclusion in the trial
Secondary ID [1] 262763 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
GIF Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inherited conditions 3908 0
Chromosomal translocations 3909 0
Condition category
Condition code
Human Genetics and Inherited Disorders 4005 4005 0 0
Cystic fibrosis
Human Genetics and Inherited Disorders 4006 4006 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Telephone genetic counselling at 3, 6 and 9 months after inclusion in the trial in addition to usual care. Genetic counsellors will phone patients who satisfy inclusion criteria to address issues around family communication of genetic information. Anticipated duration of phone call is 15-20 minutes.
Intervention code [1] 3541 0
Early detection / Screening
Intervention code [2] 3542 0
Prevention
Intervention code [3] 3543 0
Behaviour
Comparator / control treatment
The control group will receive usual care which involves the current practice of discussing the implications of the genetic information for family members, identifying relatives who might be at risk and offering a letter for the individual to give to family members, if that would be helpful. Usual practice is to see the patient at the time of diagnosis and give appropriate follow up. Usual care may vary from approximately 3-18 months depending on the particular condition and needs of the patient.
Control group
Active

Outcomes
Primary outcome [1] 4907 0
Proportion of family members accessing genetics services for either genetic counselling and/or genetic testing. Genetic files and laboratory records will be audited to determine if family members have accessed genetic services.
Timepoint [1] 4907 0
12 months after inclusion into the trial.
Secondary outcome [1] 8287 0
Participant self-report of the number of family members informed about genetic information
Timepoint [1] 8287 0
12 months after inclusion in the trial.
Secondary outcome [2] 8288 0
Process evaluation including qualitative analysis of the experiences of participants and intervention providers
Timepoint [2] 8288 0
12 months after inclusion in the trial.

Eligibility
Key inclusion criteria
1. Individuals or parents of children who are the first in a family to receive a diagnosis of a genetic condition that has implications for family members.
2. Have at least one at-risk relative living in Victoria.
3. Able to speak, read and write English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of psychiatric illness or cognitive disorder that may affect ability to provide informed consent
2. A diagnosis during pregnancy
3. Overseas or interstate patients

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1198 0
3052
Recruitment postcode(s) [2] 1199 0
3168

Funding & Sponsors
Funding source category [1] 4002 0
Government body
Name [1] 4002 0
National Health and Medical Research Council (NH&MRC)
Country [1] 4002 0
Australia
Primary sponsor type
Individual
Name
A/Prof Jane Halliday
Address
Public Health Genetics
Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Rd
Parkville, Victoria 3052
Country
Australia
Secondary sponsor category [1] 3595 0
None
Name [1] 3595 0
Address [1] 3595 0
Country [1] 3595 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6079 0
Melbourne Health
Ethics committee address [1] 6079 0
PO Royal Melbourne Hospital
Parkville
Victoria 3050
Ethics committee country [1] 6079 0
Australia
Date submitted for ethics approval [1] 6079 0
Approval date [1] 6079 0
16/07/2008
Ethics approval number [1] 6079 0
2008.068
Ethics committee name [2] 6080 0
Southern Health
Ethics committee address [2] 6080 0
246 Clayton Rd
Clayton
Victoria 3168
Ethics committee country [2] 6080 0
Australia
Date submitted for ethics approval [2] 6080 0
Approval date [2] 6080 0
29/07/2008
Ethics approval number [2] 6080 0
08095B

Summary
Brief summary
Advances in genetics research, including the Human Genome Project, have led to the availability of an increasing number of genetic tests that can give people information about their risk of developing specific genetic conditions. Genetic information given to an individual when diagnosed with a genetic condition is likely to have important health implications for their family members as well as themselves. However, the task of talking to family members about genetic information and what it means for family members can be difficult. Research has shown that commonly genetic information does not get passed on to all relevant family members and that this process is influenced by factors such as family dynamics and the complexity of the information. Despite this, current practice in genetic counselling, in keeping with Privacy laws, is for health care providers to discuss with patients attending genetic testing services the implications of their genetic information for their relatives, and the importance of the patient relaying that information to family members who have been identified as potentially at risk. Letters or information sheets for family members may be offered to the patient if they believe it would be helpful. There is much discussion about ways to improve communication of genetic information in families but very little evidence to guide practice. This study aims to evaluate a specific genetic counselling intervention to aid communication, using a robust randomised study design. Participants will be recruited from genetics clinics at several sites. Individuals who are presenting for the first time at a genetics clinic for the diagnosis of a genetic condition in themselves or their children, that has implications for family members, will be eligible to participate. They will also need to have at least one living relative who could benefit from being told the genetic information. Once participants are recruited into the study they will be randomly assigned to one of two groups. The control group will receive usual care which involves the current practice of discussing the implications of the genetic information for family members, identifying relatives who might be at risk and offering a letter for the individual to give to family members, if that would be helpful. The intervention group will receive an enhanced genetic counselling intervention where a research genetic counsellor will contact the person by phone at 3, 6 and 9 month intervals. The intervention comprises 15-20 minute telephone genetic counselling addressing family communication of genetic information. The effectiveness of the intervention will be assessed 18 months after enrolment into the study. Participants from both groups will be asked to complete a survey and the number of at-risk relatives who have attended a genetics service and/or had a genetic test will be ascertained from genetic health records. This is the first ever scientifically robust study to test an intervention to aid family communication of genetic information. It will provide evidence to guide genetic counselling practice in this important area of family communication.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29031 0
Address 29031 0
Country 29031 0
Phone 29031 0
Fax 29031 0
Email 29031 0
Contact person for public queries
Name 12188 0
Dr Jan Hodgson
Address 12188 0
Genetics Education and Health Research
Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Rd
Parkville, Victoria 3052
Country 12188 0
Australia
Phone 12188 0
+61 3 8341 6308
Fax 12188 0
+61 3 8341 6212
Email 12188 0
[email protected]
Contact person for scientific queries
Name 3116 0
A/Prof Jane Halliday
Address 3116 0
Public Health Genetics
Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Rd
Parkville, Victoria 3052
Country 3116 0
Australia
Phone 3116 0
+61 3 8341 6260
Fax 3116 0
+61 3 8341 6212
Email 3116 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
SourceTitleYear of PublicationDOI
EmbaseImproving family communication after a new genetic diagnosis: A randomised controlled trial of a genetic counselling intervention.2014https://dx.doi.org/10.1186/1471-2350-15-33
N.B. These documents automatically identified may not have been verified by the study sponsor.