OsteoArthritis and Therapy for Sleep

Status unconfirmed · Not applicable

Conditions studied: Insomnia Related to Osteoarthritis Pain

In brief

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.

Key facts

Study ID

NCT02946957

Run by

University of Washington

People needed

327

Starts

2016-10-01

Expected to finish

2020-11-01

Last updated by the study team

2020-04-03

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Kaiser Permanente Washington Research Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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