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Remotely-Delivered Benefits Counseling for Service Connection Applicants

2020年11月5日 更新者:VA Office of Research and Development
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.

研究概览

详细说明

Current application rates suggest that more than half of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans will eventually apply for some form of service-connection, with approximately 100,000 Veterans per year being evaluated for psychiatric conditions. Veterans applying for service-connection for psychiatric conditions are in distress, and often are having occupational difficulties, but these are unaddressed during a typical Compensation and Pension evaluation. Counseling that addresses beneficiaries' concerns about losing compensation payments if working for pay, when supplemented by vocational supports, has been associated with increased employment among people disabled by chronic psychiatric conditions. This group has developed an online Benefits Counseling intervention tailored to help Veterans applying for service-connection engage in work-related activities. The investigators have demonstrated the efficacy of a face-to-face version of Benefits Counseling in a completed Rehabilitation Research & Development-funded six-month clinical trial in which Veterans assigned to Benefits Counseling worked significantly more days than controls,(p<.05, effect size = 0.69), reflecting an average of three more days of employment at six month follow-up. The investigators then used a supplement from Rehabilitation Research & Development to develop a web-based version of this counseling, so that the counseling could be delivered without a counselor on-site. The web-based intervention was modified based on user feedback, but the extent to which it will be used by Veterans at home and how it will impact their behavior is unknown. In the proposed clinical trial, Veterans working two or fewer days per week who are presenting for a Compensation & Pension examination for a psychiatric disorder will be assessed at baseline and then urged to log in afterwards to a website for random assignment to either Remotely-Delivered Benefits Counseling (n=65) or Veterans Benefits Administration web sites (n=65), and will then be assessed at 4, 12, and 24 weeks after randomization in order to calculate standardized group mean differences between the slopes over time. The primary outcome measure will be the treatment-by-time slope of hours of paid work. Exploratory analyses will estimate associations of potential mediators of treatment response with this outcome. The proposed study will provide estimates of the efficacy of remotely-delivered Benefits Counseling initiated at Compensation and Pension examinations, a widely-used point of contact with VA.

研究类型

介入性

注册 (实际的)

150

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Connecticut
      • West Haven、Connecticut、美国、06516
        • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
    • Massachusetts
      • Leeds、Massachusetts、美国、01053-9764
        • VA Central Western Massachusetts Healthcare System, Leeds, MA

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 64年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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?
  • Participants will also meet the following inclusion criteria:

    • 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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Remotely Delivered Benefits Counseling
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.
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.
有源比较器:Control
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.
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Hours Per Week of Paid Work
大体时间:Assessed at baseline, and 4, 12 and 24 weeks post-randomization. Each assessment is for the period since prior assessment
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

次要结果测量

结果测量
措施说明
大体时间
Work Importance and Confidence Ruler
大体时间:Assessed at baseline, and 4, 12 and 24 weeks post-randomization. Each assessment is for the period since prior assessment

This measure consists of six questions about respondent's ability to work to his/her "fullest capacity" currently, how ready they are to work to fullest capacity, how important it is to work to fullest capacity, how important it is to work for pay, and how confident one in in ability work to fullest capacity. Items are rated on an 11 point Likert scale, ranging from 0 to 10, with higher scores indicating more importance (0 "not at all important" to 10 "very important") and more confidence (0 "not at all confident" to 10 "completely confident") in one's ability. We report the mean/median of the scores (range 0-10) at each timepoint by treatment group.

This measure has been used to show that Veteran-rated importance of work was associated with engagement in Compensated Work Therapy among Veterans with vocational and psychiatric difficulties. It was collected at Baseline, Week 4, Week 12 and week 24.

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年12月1日

初级完成 (实际的)

2019年7月1日

研究完成 (实际的)

2020年11月1日

研究注册日期

首次提交

2016年1月22日

首先提交符合 QC 标准的

2016年2月3日

首次发布 (估计)

2016年2月9日

研究记录更新

最后更新发布 (实际的)

2020年11月20日

上次提交的符合 QC 标准的更新

2020年11月5日

最后验证

2020年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • D1319-R

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

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

IPD 共享时间框架

By June 2020.

IPD 共享访问标准

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.

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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