Phase
Condition
Osteoarthritis
Insomnia
Knee Injuries
Treatment
Personalized exercise coaching
Cognitive behavioral therapy for Insomnia
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Self-reported physician diagnosis of knee osteoarthritis
Persistent knee osteoarthritis-related pain of at least moderate intensity (asindicated in the protocol)
Indication of persistent symptoms of insomnia, determined by scoring on the SleepCondition Indicator questionnaire (as indicated in the protocol)
If receiving medication for pain or sleep disturbances, having had no change inprescription in the previous three months and be willing to make no other changes tomedications for pain or sleep during the active study period.
Adequate literacy level to ensure web-based surveys can be completed independently,as assessed using a brief 3-item literacy level screener
Exclusion
Exclusion Criteria:
Concurrent diagnosis of a systemic, inflammatory musculoskeletal disorder (e.g.,rheumatoid arthritis)
Active malignancy
Neurological conditions (e.g., movement disorders)
Any medical condition which would make graded increase of physical activityunsuitable (determined by a positive answer to the question: "Has a doctor orhealthcare professional advised you to avoid physical activity for any reason?").
Unable to understand English sufficiently to take part in the intervention.
Unable to provide electronic informed consent.
Evidence of significant cognitive impairment (i.e., ≥2 errors on a 6-item cognitivescreener).
Presence of severe psychiatric disorder.
Currently participating in an interventional trial or a pain or sleep managementprogram or having done so in the past six months.
Visual or hearing impairment that would prevent use of the intervention.
Serious physical health concerns necessitating surgery or with a prognosis <6 months
Irregular sleep-wake schedule, e.g., shift work.
Self-report of diagnosis of a specific sleep disorder other than insomnia that isnot currently adequately treated, e.g., sleep apnea or narcolepsy.
Currently meeting or exceeding physical activity guidance from the U.S. Departmentof Health and Human Services (noted in protocol)
Study Design
Connect with a study center
University of Michigan
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
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