OsteoArthritis and Therapy for Sleep (OATS)
2020年4月1日 更新者:Michael Vitiello、University of Washington
Efficacy of Scalable CBT for Insomnia in Older Adults With Osteoarthritis Pain
Osteoarthritis (OA) pain affects 50 percent of older adults, more than half of whom also experience significant sleep disturbance.
This randomized trial will determine whether a telephone-based cognitive behavioral treatment targeting insomnia in older adults with chronic severe OA-related insomnia and pain results in substantially greater reductions in insomnia severity and in related improvements in pain, fatigue, mood, quality of life and healthcare costs compared to telephone-delivered education (attention control) about insomnia.
The trial will test an intervention that if demonstrated to have long term efficacy is scalable and has the potential for wide-scale deployment in healthcare systems.
調査の概要
状態
わからない
詳細な説明
Twenty-five percent of older adults experience significant osteoarthritis (OA)-related comorbid sleep disturbance.
Insomnia is associated with substantial negative effects on function, mood, and medical resource utilization.
Cognitive behavioral therapy for insomnia (CBT-I) is evidence based and has been shown to be efficacious in populations with a variety of comorbid conditions including OA-related chronic pain.
However, in-person CBT interventions are unlikely to be widely deployable in healthcare systems.
Telephone delivery has the advantage of giving patients access to personalized, efficacious CBT-I interventions from home, increasing generalizability, and outreach to minority, rural, and other underserved populations.
Older (60+ yrs) primary care patients across Washington State will be screened for severe persistent OA-related insomnia and pain.
Two hundred and seventy patients will be randomized to either CBT-I or an education only attention control (EOC).
Each treatment will consist of six 20-30 minute telephone-based sessions over an eight week period.
Pre-treatment, post-treatment (2 months and 12 month) assessments will include measures of sleep, pain, fatigue, mood, and quality of life.
A cost effectiveness evaluation of the intervention will also be conducted.
The proposed research will determine if telephone CBT-I improves OA insomnia and associated outcomes in a state-wide primary care population of older adults, and inform policy decisions about widespread dissemination of telephone CBT-I in this and related patient populations.
研究の種類
介入
入学 (実際)
327
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
-
-
Washington
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Seattle、Washington、アメリカ、98101
- Kaiser Permanente Washington Research Institute
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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
60年歳以上 (大人、高齢者)
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:
- Age 60+ with one or more health care visits for OA in the prior 3 years
- Score of ≥6 on 4-item ISI at first screening and ≥11 on full ISI at second screening
- Score of ≥9 on two items from the Brief Pain Inventory (BPI) asking about average pain intensity in the past 2 weeks (0-10 scale) and activity interference due to pain (0-10 scale) at first and second screening
Exclusion Criteria:
- Not continuously enrolled at Group Health Cooperative for at least one year
- Prior diagnosis of a primary sleep disorder: sleep apnea with an AHI/RDI score of 15+ or current use of a CPAP machine; periodic leg movement disorder; restless leg syndrome; sleep-wake cycle disturbance; or rapid eye movement behavior disorder
- Diagnosis in the medical record of: rheumatoid arthritis, terminal disease, being considered for major surgery, active chemotherapy or radiation for cancer, or inpatient treatment for congestive heart failure within the previous 6 months
- Diagnosis of dementia, use of acetylcholinesterase inhibitor and/or memantine for cognitive impairment, or cognitive impairment (>6 on the Short Orientation-Memory-Concentration Test)
- Hearing or speech impairment sufficient to preclude participation in a telephone intervention
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 |
|---|---|
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実験的:Cognitive Behavioral Therapy
Cognitive Behavioral Therapy for Insomnia is delivered by trained sleep therapists in six telephone sessions.
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Six telephone sessions that last 20-30 minutes presenting cognitive behavioral therapy for insomnia.
他の名前:
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アクティブコンパレータ:Education Control
Education Only Control is delivered by trained sleep therapists in six telephone sessions.
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Six telephone sessions that last 20-30 minutes presenting sleep and osteoarthritis education.
他の名前:
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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 |
|---|---|---|
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Insomnia Severity Index (ISI)
時間枠:12 months post baseline
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A 7-item questionnaire that is a global measure of perceived insomnia severity.
Items use a 5-point scale for total scores of 0-28, with >15 considered moderate severity.
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12 months post baseline
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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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Insomnia Severity Index (ISI)
時間枠:2 months post baseline
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A 7-item questionnaire that is a global measure of perceived insomnia severity.Items use a 5-point scale for total scores of 0-28, with >15 considered moderate severity.
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2 months post baseline
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Pittsburgh Sleep Quality Index (PSQI)
時間枠:2 months post baseline
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Self-rating of overall sleep quality and disturbances using 7 sleep.
components.
PSQI global >5 is highly sensitive and specific for distinguishing good and poor sleepers.
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2 months post baseline
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Pittsburgh Sleep Quality Index (PSQI)
時間枠:12 months post baseline
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Self-rating of overall sleep quality and disturbances using 7 sleep components.
PSQI global >5 is highly sensitive and specific for distinguishing good and poor sleepers.
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12 months post baseline
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Brief Pain Inventory-short form (BPI-sf)
時間枠:2 months post baseline
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A questionnaire to assess pain intensity and interference with activities.
The BPI-sf rates pain intensity (4 items) and interference (7 items) from 0 to 10 and is validated for use in clinical trials with OA pain patients.
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2 months post baseline
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Brief Pain Inventory-short form (BPI-sf)
時間枠:12 months post baseline
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A questionnaire to assess pain intensity and interference with activities.
The BPI-sf rates pain intensity (4 items) and interference (7 items) from 0 to 10 and is validated for use in clinical trials with OA pain patients.
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12 months post baseline
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Flinders Fatigue Scale (FFS)
時間枠:2 months post baseline
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A 7-item self-report questionnaire to measure fatigue level in a variety of situations.
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2 months post baseline
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Flinders Fatigue Scale (FFS)
時間枠:12 months post baseline
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A 7-item self-report questionnaire to measure fatigue level in a variety of situations.
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12 months post baseline
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Patient Health Questionnaire (PHQ-8)
時間枠:2 months post baseline
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4-point scale rates frequency of occurrence of 8 depressive symptoms.
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2 months post baseline
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Patient Health Questionnaire (PHQ-8)
時間枠:12 months post baseline
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4-point scale rates frequency of occurrence of 8 depressive symptoms.
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12 months post baseline
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Sleep Hygiene Index (SHI)
時間枠:2 months post baseline
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A 13-item scale that rates how often participants engage in specific sleep hygiene related behaviors, including continued adherence to CBT-I recommendations over time.
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2 months post baseline
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Sleep Hygiene Index (SHI)
時間枠:12 months post baseline
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A 13-item scale that rates how often participants engage in specific sleep hygiene related behaviors, including continued adherence to CBT-I recommendations over time.
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12 months post baseline
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EuroQoL 5D (EQ-5D)
時間枠:2 months post baseline
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Rates health status on five dimensions and overall health status from 0 to 100.
The most widely used measure in clinical trials assessing general quality of life of OA patients.
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2 months post baseline
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EuroQoL 5D (EQ-5D)
時間枠:12 months post baseline
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Rates health status on five dimensions and overall health status from 0 to 100.
The most widely used measure in clinical trials assessing general quality of life of OA patients.
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12 months post baseline
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Western Ontario and McMaster Universities Arthritis Index (WOMAC)
時間枠:2 months post baseline
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A 24-item questionnaire rating pain, stiffness, and physical functioning in everyday activities.
It is the most widely used condition-specific quality of life measure for arthritis cost-effectiveness studies.
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2 months post baseline
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Western Ontario and McMaster Universities Arthritis Index (WOMAC)
時間枠:12 months post baseline
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A 24-item questionnaire rating pain, stiffness, and physical functioning in everyday activities.
It is the most widely used condition-specific quality of life measure for arthritis cost-effectiveness studies.
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12 months post baseline
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Use of sleep and pain medications
時間枠:Baseline through 24 months
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NSAID, analgesic, sedative, and anti-depressant medication use.
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Baseline through 24 months
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Outpatient visits
時間枠:Baseline through 24 months
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The number of visits for OA, for sleep problems, and for visits irrespective of associated diagnosis.
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Baseline through 24 months
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Health care costs
時間枠:Baseline through 24 months
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The Group Health cost database will be used to estimate costs (from study entry to 24 months post enrollment) of ambulatory healthcare for all conditions, arthritis and sleep problems, and inpatient care.
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Baseline through 24 months
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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。
スポンサー
捜査官
- 主任研究者:Michael V Vitiello, PhD、University of Washington
- 主任研究者:Michael Von Korff, ScD、University of Washington
- 主任研究者:Kai Yeung, PhD、Kaiser Permanente
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Thakral M, Von Korff M, McCurry SM, Morin CM, Vitiello MV. ISI-3: evaluation of a brief screening tool for insomnia. Sleep Med. 2021 Jun;82:104-109. doi: 10.1016/j.sleep.2020.08.027. Epub 2020 Aug 27.
- Vitiello MV, Zhu W, Von Korff M, Wellman R, Morin CM, Yeung K, McCurry SM. Long-term improvements in sleep, pain, depression, and fatigue in older adults with comorbid osteoarthritis pain and insomnia. Sleep. 2022 Feb 14;45(2):zsab231. doi: 10.1093/sleep/zsab231.
- McCurry SM, Zhu W, Von Korff M, Wellman R, Morin CM, Thakral M, Yeung K, Vitiello MV. Effect of Telephone Cognitive Behavioral Therapy for Insomnia in Older Adults With Osteoarthritis Pain: A Randomized Clinical Trial. JAMA Intern Med. 2021 Apr 1;181(4):530-538. doi: 10.1001/jamainternmed.2020.9049.
- McCurry SM, Von Korff M, Morin CM, Cunningham A, Pike KC, Thakral M, Wellman R, Yeung K, Zhu W, Vitiello MV. Telephone interventions for co-morbid insomnia and osteoarthritis pain: The OsteoArthritis and Therapy for Sleep (OATS) randomized trial design. Contemp Clin Trials. 2019 Dec;87:105851. doi: 10.1016/j.cct.2019.105851. Epub 2019 Oct 13.
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
2016年10月1日
一次修了 (実際)
2019年12月1日
研究の完了 (予想される)
2020年11月1日
試験登録日
最初に提出
2016年10月19日
QC基準を満たした最初の提出物
2016年10月25日
最初の投稿 (見積もり)
2016年10月27日
学習記録の更新
投稿された最後の更新 (実際)
2020年4月3日
QC基準を満たした最後の更新が送信されました
2020年4月1日
最終確認日
2020年3月1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。