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OsteoArthritis and Therapy for Sleep (OATS)

1. april 2020 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

327

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Washington
      • Seattle, Washington, Forente stater, 98101
        • Kaiser Permanente Washington Research Institute

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

60 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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Sponsor

University of Washington

Samarbeidspartnere

Kaiser Permanente

Etterforskere

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

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2016

Primær fullføring (Faktiske)

1. desember 2019

Studiet fullført (Forventet)

1. november 2020

Datoer for studieregistrering

Først innsendt

19. oktober 2016

Først innsendt som oppfylte QC-kriteriene

25. oktober 2016

Først lagt ut (Anslag)

27. oktober 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. april 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. april 2020

Sist bekreftet

1. mars 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 52176

Plan for individuelle deltakerdata (IPD)

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NEI

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