Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000422527
Ethics application status
Approved
Date submitted
7/09/2006
Date registered
29/09/2006
Date last updated
26/09/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Vietnam Veterans - Real Partners in Health: Does self-management support improve your health?
Scientific title
Research into the effects of the clinical application of the Flinders Model of chronic condition self-management on the health, psychosocial and quality of life outcomes of Vietnam Veterans with alcohol-related chronic conditions
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol-related disorders in Vietnam Veterans 1391 0
Post Traumatic Stress Disorder in Vietnam Veterans 1392 0
Major Depression in Vietnam Veterans 1393 0
Condition category
Condition code
Mental Health 1485 1485 0 0
Depression
Mental Health 1486 1486 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive "usual care" plus The Flinders Model of Chronic Condition Self-Management, together with any/all of the interventions listed, but agreed between a health professional and the patient:
Treatment options (based on the Alcohol Practice Guidelines) may include
• Medical management using naltrexone (50mg tablets, orally, once per day, for an initial period of 3 months but may extend up to 9 months) or acamprosate (330mg x 2 tablets, orally, three times per day for an initial period of 3 months but may extend up to 9 months);
• Self-management of alcohol problems using the web based program ‘the right mix’; www.therightmix.gov.au (duration: ongoing as needed by each individual);
• Individual counselling using cognitive behaviour therapy based on motivational interviewing, cue exposure, cognitive restructuring and relapse prevention will be provided in the community through Drug and Alcohol Services SA (DASSA) and Vietnam Veterans Counselling Service (VVCS) (duration 30-90 minutes per session for as many sessions required by each individual);
• Group therapy (Stanford six-week generic self-management course - 2 1/2 hours per one session per week).
• “Drink Watchers: A self-monitoring approach” (duration: ongoing per individual, as needed);
• Alcoholics Anonymous (duration approx 2 hours per session, once per week, for as many sessions as the Veteran requires).
Each group will be offered the same treatment options during a nine month period which will be agreed between the participant, their GP and other health providers. One group will be supported in self-management techniques with the Flinders Model of self-management in the first nine months, with nine months follow-up, and the other group will be supported in self-management in the second nine months. Total intervention period 18 months.
Intervention code [1] 1351 0
Lifestyle
Comparator / control treatment
The control group will receive "usual care", ie the care usually provided to the individual.
Control group
Active

Outcomes
Primary outcome [1] 2056 0
Improved alcohol-related disability through the development and testing of a comprehensive integrated management strategy for Vietnam Veterans with alcohol and related disorders which can be be implemented in all other Veteran treatment settings.
Timepoint [1] 2056 0
At baseline, three months, six months, nine months, and eighteen months
Primary outcome [2] 2057 0
Improved quality of life through the development and testing of a comprehensive integrated management strategy for Vietnam Veterans with alcohol and related disorders which can be be implemented in all other Veteran treatment settings.
Timepoint [2] 2057 0
At baseline, three months, six months, nine months, and eighteen months
Secondary outcome [1] 3546 0
Improved self-management of alcohol and co-morbid conditions.
Timepoint [1] 3546 0
Measured at baseline, three months, six months, nine months, and eighteen months.

Eligibility
Key inclusion criteria
Must have been in the Vietnam Conflict and have an alcohol related chronic condition - Each Vietnam Veteran will need to have an Audit score (Alcohol Usage Disorders Identification Test) of 8 or above.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Physical or mental impairment so as not to be able to give informed consent or cooperate with trial procedures.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involves contacting the holder of the allocation schedule who is at central administration
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software by one person with password protected access to file
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects are blind
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1623 0
Government body
Name [1] 1623 0
Department of Veteran Affairs
Country [1] 1623 0
Australia
Primary sponsor type
Government body
Name
Department of Veteran Affairs
Address
Country
Australia
Secondary sponsor category [1] 1424 0
None
Name [1] 1424 0
Nil
Address [1] 1424 0
Country [1] 1424 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3069 0
Department of Veterans Affairs
Ethics committee address [1] 3069 0
Ethics committee country [1] 3069 0
Australia
Date submitted for ethics approval [1] 3069 0
Approval date [1] 3069 0
11/08/2006
Ethics approval number [1] 3069 0
0533
Ethics committee name [2] 3070 0
Repatriation General Hospital Daw Park
Ethics committee address [2] 3070 0
Ethics committee country [2] 3070 0
Australia
Date submitted for ethics approval [2] 3070 0
Approval date [2] 3070 0
27/09/2006
Ethics approval number [2] 3070 0
41/06

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

Contacts
Principal investigator
Name 27958 0
Address 27958 0
Country 27958 0
Phone 27958 0
Fax 27958 0
Email 27958 0
Contact person for public queries
Name 10540 0
Dr Sarah Blunden
Address 10540 0
Flinders Human Behaviour & Health Research Unit
Margaret Tobin Centre
GPO Box 2100
Adelaide SA 5001
Country 10540 0
Australia
Phone 10540 0
+61 8 84042323
Fax 10540 0
+61 8 84042101
Email 10540 0
[email protected]
Contact person for scientific queries
Name 1468 0
Assoc Prof Malcolm Battersby
Address 1468 0
Flinders Human Behaviour & Health Research Unit
Margaret Tobin Centre
GPO Box 2100
Adelaide SA 5001
Country 1468 0
Australia
Phone 1468 0
+61 8 84042323
Fax 1468 0
+61 8 84042101
Email 1468 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.