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OsteoArthritis and Therapy for Sleep (OATS)

1. april 2020 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

327

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater, 98101
        • Kaiser Permanente Washington Research Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy for Insomnia is delivered by trained sleep therapists in six telephone sessions.
Adfærdsmæssigt: Cognitive Behavior Therapy for Insomnia
Six telephone sessions that last 20-30 minutes presenting cognitive behavioral therapy for insomnia.
Andre navne:
  • CBT-I
Aktiv komparator: Education Control
Education Only Control is delivered by trained sleep therapists in six telephone sessions.
Adfærdsmæssigt: Education Only Control
Six telephone sessions that last 20-30 minutes presenting sleep and osteoarthritis education.
Andre navne:
  • EOC

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Insomnia Severity Index (ISI)
Tidsramme: 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.
12 months post baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Insomnia Severity Index (ISI)
Tidsramme: 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.
2 months post baseline
Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: 2 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.
2 months post baseline
Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: 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.
12 months post baseline
Brief Pain Inventory-short form (BPI-sf)
Tidsramme: 2 months post baseline
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.
2 months post baseline
Brief Pain Inventory-short form (BPI-sf)
Tidsramme: 12 months post baseline
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.
12 months post baseline
Flinders Fatigue Scale (FFS)
Tidsramme: 2 months post baseline
A 7-item self-report questionnaire to measure fatigue level in a variety of situations.
2 months post baseline
Flinders Fatigue Scale (FFS)
Tidsramme: 12 months post baseline
A 7-item self-report questionnaire to measure fatigue level in a variety of situations.
12 months post baseline
Patient Health Questionnaire (PHQ-8)
Tidsramme: 2 months post baseline
4-point scale rates frequency of occurrence of 8 depressive symptoms.
2 months post baseline
Patient Health Questionnaire (PHQ-8)
Tidsramme: 12 months post baseline
4-point scale rates frequency of occurrence of 8 depressive symptoms.
12 months post baseline
Sleep Hygiene Index (SHI)
Tidsramme: 2 months post baseline
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.
2 months post baseline
Sleep Hygiene Index (SHI)
Tidsramme: 12 months post baseline
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.
12 months post baseline
EuroQoL 5D (EQ-5D)
Tidsramme: 2 months post baseline
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.
2 months post baseline
EuroQoL 5D (EQ-5D)
Tidsramme: 12 months post baseline
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.
12 months post baseline
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Tidsramme: 2 months post baseline
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.
2 months post baseline
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Tidsramme: 12 months post baseline
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.
12 months post baseline
Use of sleep and pain medications
Tidsramme: Baseline through 24 months
NSAID, analgesic, sedative, and anti-depressant medication use.
Baseline through 24 months
Outpatient visits
Tidsramme: Baseline through 24 months
The number of visits for OA, for sleep problems, and for visits irrespective of associated diagnosis.
Baseline through 24 months
Health care costs
Tidsramme: Baseline through 24 months
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.
Baseline through 24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Washington

Samarbejdspartnere

Kaiser Permanente

Efterforskere

  • Ledende efterforsker: Michael V Vitiello, PhD, University of Washington
  • Ledende efterforsker: Michael Von Korff, ScD, University of Washington
  • Ledende efterforsker: Kai Yeung, PhD, Kaiser Permanente

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2016

Primær færdiggørelse (Faktiske)

1. december 2019

Studieafslutning (Forventet)

1. november 2020

Datoer for studieregistrering

Først indsendt

19. oktober 2016

Først indsendt, der opfyldte QC-kriterier

25. oktober 2016

Først opslået (Skøn)

27. oktober 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. april 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. april 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 52176

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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