DisabilityPhase 1NCT00530985
Preserving Function Among Disability Applicants
A Phase 1 study testing Benefits Counseling and VA Orientation in people with Disability, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
To test the hypothesis that veterans counseled around managing their benefits will work more and have a better quality of life than those receiving non-specific counseling. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Disability
- What is being tested?
- Benefits Counseling and VA Orientation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jun 2009
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Applying for VA service connection and not currently receiving VBA benefits.
- Veterans who have been rated 0% service-connected but do not receive financial benefits are eligible to participate.
- Able to provide valid consent
- Age 18-65
- Expresses willingness to discuss benefits with a counselor
- Anticipates difficulty working
Who cannot join
- Already receiving VA payments
- Already receiving SSI or SSDI
- Has a conservator
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, 06516
About this study
Official title: Preserving Function Among Disability Applicants: A Motivational Enhancement Approach to Benefits Counseling
To test the hypothesis that veterans counseled around managing their benefits will work more and have a better quality of life than those receiving non-specific counseling.
Read the detailed description
The aim is to develop and test the efficacy of Benefits Counseling to improve quality of life among veterans who apply for VA benefits. Benefits Counseling involves providing claimants information about rehabilitation and work-related activities, benefits determination and management, and available substance abuse treatment . Benefits Counseling is designed to increase motivation to be active and promote engagement in substance abuse treatment. After enrolling 15 participants in an open-label pilot phase, 300 veterans who are not receiving benefits and are applying to VBA for disability benefits will be randomly assigned to Benefits Counseling or the control condition, VA Orientation, and both groups will be followed for one year.
The primary outcome measures will be observer-rated and self-rated quality of life. Secondary outcome measures will include substance use and treatment utilization.
- Conditions
- Disability
- Being tested
- Benefits Counseling, VA Orientation
- Keywords
- disability, substance abuse, vocational rehabilitation, case management
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benefits CounselingBehavioural
Help deciding whether to work
VA OrientationBehavioural
Orientation to services available at VA
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Benefits Counseling Receives: Behavioral: Benefits Counseling |
| 2 | Active comparator | VA Orientation Receives: Behavioral: VA Orientation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days engaged in work and work-related activities
Measured: 6 months
Secondary outcomes (2)
substance use (as measured by days having used illicit drugs, alcohol to intoxication in the preceding days)
Measured: 6 months
treatment utilization (days in last 30 having participated in rehabilitation and work-related activities, number of days having participated in non-inpatient substance abuse treatment, number of days on any inpatient unit)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2007 (estimated)
- Study startFeb 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Marc I. Rosen, MD, Principal investigator, VA Connecticut Health Care System (West Haven)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530985
- Sponsor's protocol ID
- MR0024
- Other IDs
- MIRECC
- Status last verified
- Jun 2009
- First submitted
- 16 Sep 2007
- Last updated
- 2 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preserving Function Among Disability Applicants: A Motivational Enhancement Approach to Benefits Counseling
- ClinicalTrials.gov ID
- NCT00530985
- Acronym / sponsor ID
- MR0024
- Conditions
- Disability
- Keywords
- disability, substance abuse, vocational rehabilitation, case management
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Feb 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 18 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the hypothesis that veterans counseled around managing their benefits will work more and have a better quality of life than those receiving non-specific counseling.
Detailed description
The aim is to develop and test the efficacy of Benefits Counseling to improve quality of life among veterans who apply for VA benefits. Benefits Counseling involves providing claimants information about rehabilitation and work-related activities, benefits determination and management, and available substance abuse treatment . Benefits Counseling is designed to increase motivation to be active and promote engagement in substance abuse treatment. After enrolling 15 participants in an open-label pilot phase, 300 veterans who are not receiving benefits and are applying to VBA for disability benefits will be randomly assigned to Benefits Counseling or the control condition, VA Orientation, and both groups will be followed for one year.
The primary outcome measures will be observer-rated and self-rated quality of life. Secondary outcome measures will include substance use and treatment utilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Benefits CounselingBenefits Counseling |
| 2 | Active comparator | Behavioral: VA OrientationVA Orientation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Applying for VA service connection and not currently receiving VBA benefits.
- Veterans who have been rated 0% service-connected but do not receive financial benefits are eligible to participate.
- Able to provide valid consent
- Age 18-65
- Expresses willingness to discuss benefits with a counselor
Key exclusion criteria (3 listed)
- Already receiving VA payments
- Already receiving SSI or SSDI
- Has a conservator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benefits CounselingHelp deciding whether to work | Behavioural | 1 |
| VA OrientationOrientation to services available at VA | Behavioural | 2 |
Primary outcome
Days engaged in work and work-related activities
Time frame: 6 months
2 secondary outcomes
substance use (as measured by days having used illicit drugs, alcohol to intoxication in the preceding days)
Time frame: 6 months
treatment utilization (days in last 30 having participated in rehabilitation and work-related activities, number of days having participated in non-inpatient substance abuse treatment, number of days on any inpatient unit)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc I. Rosen, MD principal investigator
VA Connecticut Health Care System (West Haven)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Benefits Counseling and VA Orientation in people with Disability, run by US Department of Veterans Affairs at 1 site in United States.
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 6 inclusion and 3 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 Jul 2009. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Days engaged in work and work-related activities (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2009.