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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
150
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Connecticut
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West Haven、Connecticut、アメリカ、06516
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
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Massachusetts
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Leeds、Massachusetts、アメリカ、01053-9764
- VA Central Western Massachusetts Healthcare System, Leeds, MA
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～64年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
アクティブコンパレータ：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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hours Per Week of Paid Work
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Work Importance and Confidence Ruler
時間枠：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
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2015年12月1日
一次修了 (実際)
2019年7月1日
研究の完了 (実際)
2020年11月1日
試験登録日
最初に提出
2016年1月22日
QC基準を満たした最初の提出物
2016年2月3日
最初の投稿 (見積もり)
2016年2月9日
学習記録の更新
投稿された最後の更新 (実際)
2020年11月20日
QC基準を満たした最後の更新が送信されました
2020年11月5日
最終確認日
2020年11月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- D1319-R
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Only with a data sharing agreement.
There is no provision for data sharing in the approved IRB protocol.
IPD 共有時間枠
By June 2020.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。