職場復帰リハビリテーションの評価
筋骨格系、非特異的、および/または一般的な精神保健障害で一時的に仕事を離れている人のための、入院患者の仕事復帰のための多要素のリハビリテーション プログラムの評価。ランダム化対照試験
Long-term sick-listing from work has considerable impact on social function, on the families of the sick-listed persons, the companies they work for, and society as a whole. Hence, the need for documented effective vocational rehabilitation programs is pressing. Vocational rehabilitation services described in the scientific literature have been specific to one single or a specific group of medical conditions (e.g.low back pain). In contrast, most people on sick leave have several health complaints, and many of the factors influencing sick leave are shared regardless of disorder (e.g. social surroundings, workplace environment), calling for rehabilitation programs that can be employed for both musculoskeletal-, unspecific- and common mental disorders. Aim of this study is to investigate whether a group based rehabilitation program for musculoskeletal, mental or unspecific complaints can facilitate return-to-work (RTW), thereby testing two multicomponent return-to-work RTW rehabilitation programs.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Rissa、ノルウェー
- Hysnes Rehabilitation Centre
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Trondheim、ノルウェー
- St. Olavs University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- living in the counties of Trøndelag
- on sick leave 2-12 months
- current sick leave status of 50% - 100%
- ICPC-2 (International Classification of Primary Care, Second edition) diagnosis within the L (musculoskeletal), P (psychiatric) or A (unspecific disorders) categories
Exclusion Criteria:
- alcohol or drug abuse
- serious somatic or psychological disorders
- a specific disorder requiring specialized treatment
- pregnancy
- currently participating in another treatment program
- insufficient Norwegian speaking or writing skills to participate in group session and fill out questionnaires
- scheduled for surgery within the next 6 months
- serious problems with functioning in a group setting
研究計画
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：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：long rehabilitation
a 3.5-week, in-patient rehabilitation program, organized as a 7-hour workday with weekends off, simulating a close to normal summer work-week in Norway, and mainly group-based with maximum 8 participants per group. Focus on mental training (aimed at increasing motivation and self-efficacy), physical training and work-related problem solving. |
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実験的：short rehabilitation
4+4 full days of rehabilitation at Hysnes Rehabilitation Center, separated by 2 weeks living at home. Group-based with 8 participants per group, focus on mental training (aimed at increasing motivation and self-efficacy), physical training and work-related problem solving. A workplace visit will be included in addition to the 4 + 4 rehabilitation days, if considered relevant. |
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アクティブコンパレータ：Acceptance and commitment therapy
6 dynamic processes (committed action, self-as-context, presence in the moment, values, defusion and acceptance) are targeted both in group-sessions and individual meetings. Only the psychological part of the experimental interventions is applied, in an outpatient setting. |
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介入なし：Untouched
this group will be followed in registers at group level and not be aware of their participation in the study |
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 |
|---|---|---|
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time until full sustainable return-to-work (RTW)
時間枠：1 year
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return-to-work i.e. for at least 4 weeks without relapse |
1 year
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Total number of sickness absence days
時間枠：1 year
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after enrollment in the study (i.e. after pre-screening) |
1 year
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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病気欠勤日
時間枠：3年
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3年
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病気欠勤日
時間枠：5年
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5年
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健康関連の生活の質
時間枠：1年
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1年
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身体活動
時間枠：1年
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1年
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身体的、社会的、感情的な機能状態
時間枠：1年
|
1年
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心理的および社会的要因が働いている
時間枠：1年
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1年
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仕事復帰の準備
時間枠：1年
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1年
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恐怖回避信念
時間枠：1年
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1年
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心理的な柔軟性と受容性
時間枠：1年
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1年
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職場での労働者の割合
時間枠：1年
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1年
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Subjective health complaints
時間枠：1 year
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Pain, depression, anxiety, and other subjective complaints |
1 year
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Health economics from the societal perspective
時間枠：1 year
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Cost-effectiveness, cost-utility and cost-benefit methods. |
1 year
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協力者と研究者
捜査官
- スタディディレクター：Roar Johnsen, phd prof、Norwegian University of Science and Technology
出版物と役立つリンク
一般刊行物
- Fimland MS, Vasseljen O, Gismervik S, Rise MB, Halsteinli V, Jacobsen HB, Borchgrevink PC, Tenggren H, Johnsen R. Occupational rehabilitation programs for musculoskeletal pain and common mental health disorders: study protocol of a randomized controlled trial. BMC Public Health. 2014 Apr 16;14:368. doi: 10.1186/1471-2458-14-368.
- Aasdahl L, Pape K, Vasseljen O, Johnsen R, Gismervik S, Halsteinli V, Fleten N, Nielsen CV, Fimland MS. Effect of Inpatient Multicomponent Occupational Rehabilitation Versus Less Comprehensive Outpatient Rehabilitation on Sickness Absence in Persons with Musculoskeletal- or Mental Health Disorders: A Randomized Clinical Trial. J Occup Rehabil. 2018 Mar;28(1):170-179. doi: 10.1007/s10926-017-9708-z.
- Nordstoga AL, Mork PJ, Steiro Fimland M. Improved cardiorespiratory fitness after occupational rehabilitation in merged diagnostic groups. Ann Occup Environ Med. 2018 Feb 28;30:16. doi: 10.1186/s40557-018-0227-y. eCollection 2018.
- Aasdahl L, Pape K, Vasseljen O, Johnsen R, Fimland MS. Improved Expectations About Length of Sick Leave During Occupational Rehabilitation Is Associated with Increased Work Participation. J Occup Rehabil. 2019 Sep;29(3):475-482. doi: 10.1007/s10926-018-9808-4.
- Aasdahl L, Pape K, Vasseljen O, Johnsen R, Gismervik S, Jensen C, Fimland MS. Effects of Inpatient Multicomponent Occupational Rehabilitation versus Less Comprehensive Outpatient Rehabilitation on Somatic and Mental Health: Secondary Outcomes of a Randomized Clinical Trial. J Occup Rehabil. 2017 Sep;27(3):456-466. doi: 10.1007/s10926-016-9679-5.
- Skagseth M, Fimland MS, Ivar Lund Nilsen T, Aasdahl L. Physical activity after inpatient occupational rehabilitation: Secondary outcomes of two randomized controlled trials. Scand J Med Sci Sports. 2020 Feb;30(2):339-348. doi: 10.1111/sms.13577. Epub 2019 Oct 30.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (推定)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。