OsteoArthritis and Therapy for Sleep (OATS)
1 avril 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
327
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Washington
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Seattle, Washington, États-Unis, 98101
- Kaiser Permanente Washington Research Institute
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
60 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
Autres noms:
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Comparateur actif: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Insomnia Severity Index (ISI)
Délai: 12 months post baseline
|
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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Insomnia Severity Index (ISI)
Délai: 2 months post baseline
|
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)
Délai: 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)
Délai: 12 months post baseline
|
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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Michael V Vitiello, PhD, University of Washington
- Chercheur principal: Michael Von Korff, ScD, University of Washington
- Chercheur principal: Kai Yeung, PhD, Kaiser Permanente
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2016
Achèvement primaire (Réel)
1 décembre 2019
Achèvement de l'étude (Anticipé)
1 novembre 2020
Dates d'inscription aux études
Première soumission
19 octobre 2016
Première soumission répondant aux critères de contrôle qualité
25 octobre 2016
Première publication (Estimation)
27 octobre 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 avril 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 avril 2020
Dernière vérification
1 mars 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 52176
Plan pour les données individuelles des participants (IPD)
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