Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT02946957
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT02946957
Study Brief:
Protocol Section:
NCT02946957