NCT02677428

Brief Summary

A significant portion of Veterans who apply for disability benefits have difficulty finding and sustaining employment, and are concerned that working for pay will jeopardize their receipt of service-connection benefits. In a completed clinical trial, Veterans who received Motivational Interview-formatted counseled about opportunities to work and receive service-connection went on to work for pay significantly more often than controls. The proposed clinical trial will test this counseling's efficacy when it is delivered by an automated computer program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 3, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

3.6 years

First QC Date

January 22, 2016

Results QC Date

June 30, 2020

Last Update Submit

November 5, 2020

Conditions

Job SatisfactionUnemployment

Keywords

Veteransworld wide webCounselingWorkman's Compensation

Outcome Measures

Primary Outcomes (1)

  • Hours Per Week of Paid Work

    This calendar measure will be used to determine whether, and on what days the Veteran engaged in paid work activities.

    Assessed at baseline, and 4, 12 and 24 weeks post-randomization. Each assessment is for the period since prior assessment

Secondary Outcomes (1)

  • Work Importance and Confidence Ruler

    Assessed at baseline, and 4, 12 and 24 weeks post-randomization. Each assessment is for the period since prior assessment

Study Arms (2)

Remotely Delivered Benefits Counseling

EXPERIMENTAL

Veterans will complete three intervention modules online. For the first module, Veterans will be instructed on how to use the website and its purpose; will be asked about their perception of the relationship between disability benefits and work. An explanation of relationship between disability benefits and work will be provided. For the second module, Veterans' feelings and attitudes towards employment will be solicited. Motivational Interviewing exercises will be implemented; barriers to work including the disabling condition and consideration of treatment for disabling conditions will be reviewed. An action plan will be developed. For the third module, inquiries will be made regarding the Veteran's reaction to the service-connection decision; information will be provided on how to appeal the decision. Veterans will be asked to reconsider work and financial goals in light of service-connection award. Their action plan will be reviewed. Follow-up resources will be provided.

Behavioral: Remotely-Delivered Benefits Counseling

Control

ACTIVE COMPARATOR

The control condition will involve referrals to VA websites and represents enhanced treatment-as-usual. A Veteran who completes a Compensation examination ordinarily has no further treatment or referral as part of the Compensation examination. The information about benefits-related websites controls for having information available about benefits and receiving encouragement to pursue that information. The control condition involves being urged to explore links to three VA websites with Compensation \& Pension-related information: (a) the Veterans Benefits Administration (VBA) website with links about VA disability compensation, (b) the VBA site with fact sheets about the different types of benefits available to Veterans, and (c) the VBA websites for the local C\&P office where issues pertaining to an individual Veteran's specific application are addressed.

Behavioral: Control

Interventions

Remotely-Delivered Benefits CounselingBEHAVIORAL

Veterans will complete three intervention modules online. For the first module, Veterans will be instructed on how to use the website and its purpose; will be asked about their perception of the relationship between disability benefits and work. An explanation of relationship between disability benefits and work will be provided. For the second module, Veterans' feelings and attitudes towards employment will be solicited. Motivational Interviewing exercises will be implemented; barriers to work including the disabling condition and consideration of treatment for disabling conditions will be reviewed. An action plan will be developed. For the third module, inquiries will be made regarding the Veteran's reaction to the service-connection decision; information will be provided on how to appeal the decision. Veterans will be asked to reconsider work and financial goals in light of service-connection award. Their action plan will be reviewed. Follow-up resources will be provided.

Remotely Delivered Benefits Counseling
ControlBEHAVIORAL

The control condition will involve referrals to VA websites and represents enhanced treatment-as-usual. A Veteran who completes a Compensation examination ordinarily has no further treatment or referral as part of the Compensation examination. The information about benefits-related websites controls for having information available about benefits and receiving encouragement to pursue that information. The control condition involves being urged to explore links to three VA websites with Compensation \& Pension-related information: (a) the VBA website with links about VA disability compensation, (b) the VBA site with fact sheets about the different types of benefits available to Veterans, and (c) the VBA websites for the local C\&P office where issues pertaining to an individual Veteran's specific application are addressed.

Control

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All enrolled participants will have difficulty working as evidenced by a "Yes" response to any sub-part of the following question:
  • During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious):
  • (a) Cut down on the amount of time you spent on work or other activities?
  • (b) Accomplished less than you would like?
  • (c) Didn't do work or other activities as carefully as usual?
  • i. A Compensation and Pension evaluation by a psychiatrist or psychologist is scheduled
  • ii. Does not have a service-connected physical disability rated over 30%
  • iii. Is not service-connected for a psychiatric condition (0% service-connection is allowed, as Veterans with 0% service-connection have not received any benefit payments)
  • iv. Age 18-65
  • v. Reports access to an internet-connected computer/tablet and a working telephone
  • vi. Reports working an average of two or fewer days per week for pay over the preceding 4 weeks
  • vii. Self-reported ability to participate psychologically and physically, able to give informed consent and complete assessments; viii. Reports being able to read (this is necessary for understanding the website)
  • ix. Expressed interest in sampling whatever website is provided

You may not qualify if:

  • Already receiving Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI)
  • Has a conservator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

Location

VA Central Western Massachusetts Healthcare System, Leeds, MA

Leeds, Massachusetts, 01053-9764, United States

Location

Results Point of Contact

Title
Marc Rosen
Organization
VA Connecticut Healthcare System
marc.rosen@va.go
203-932-5711

Study Officials

  • Marc I. Rosen, MD

    VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2016

First Posted

February 9, 2016

Study Start

December 1, 2015

Primary Completion

July 1, 2019

Study Completion

November 1, 2020

Last Updated

November 20, 2020

Results First Posted

August 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Only with a data sharing agreement. There is no provision for data sharing in the approved IRB protocol.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
By June 2020.
Access Criteria
After a data sharing agreement has been entered into. The plan will specify the requester, purpose, and agreement to keep the data confidential and not disclose it further.

Locations

US(2)