Move and Snooze: Adding Insomnia Treatment to an Exercise Program to Improve Pain Outcomes in Older Adults With Knee Osteoarthritis

Обзор

This research will compare the effectiveness of a remotely delivered personalized exercise coaching plus an evidence-based sleep improvement intervention to remotely delivered personalized exercise coaching alone for knee osteoarthritis pain. The study team hypothesize that the combined intervention will result in greater improvements in patient-reported pain intensity, recorded with real-time data capture, than remotely delivered exercise coaching alone.

Вмешательства

• Поведенческое Personalized exercise coaching
  This is a 6-session personalized exercise coaching program (delivered over 8 weeks). All participants will complete six 30-minute scheduled online or phone sessions with a health coach as part of a manualized personalized exercise program (once per week for the first four sessions and then once every two weeks for the remaining two sessions).
• Поведенческое Cognitive behavioral therapy for Insomnia
  This is a 6-week course of automated, digitally delivered cognitive behavioral therapy for insomnia delivered by the online program Sleepio. The weekly sessions will last approximately 15-20 minutes. Session content comprises evidence-based cognitive and behavioral techniques including Stimulus Control Therapy and Sleep Restriction Therapy, sleep hygiene education, and relaxation exercises.

Первичные конечные точки

• Change in average pain intensity using a 0-10 numerical rating scale between baseline and the 8-week follow-up (post-intervention) period [Срок оценки: Baseline, 8-week follow-up (post-intervention)]

Вторичные конечные точки (5)

• Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a questionnaire between baseline and 8-week follow-up (post-intervention) [Срок оценки: Baseline, 8-week (post-intervention)]
• Change in the PROMIS Pain Interference 8a questionnaire between baseline and 8-week follow-up (post-intervention) [Срок оценки: Baseline, 8-week (post-intervention)]
• Change in the PROMIS Physical Function questionnaire between baseline and 8-week follow-up (post-intervention) [Срок оценки: Baseline, 8-week (post-intervention)]
• Change in the Quality of Life subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS) between baseline and 8-week follow-up (post-intervention) [Срок оценки: Baseline, 8-week (post-intervention)]
• Patient Global Impression of Change at 8-week follow-up (post-intervention) [Срок оценки: 8-week (post-intervention)]

Критерии участия

Критерии включения

• Self-reported physician diagnosis of knee osteoarthritis
• Persistent knee osteoarthritis-related pain of at least moderate intensity (as indicated in the protocol)
• Indication of persistent symptoms of insomnia, determined by scoring on the Sleep Condition Indicator questionnaire (as indicated in the protocol)
• If receiving medication for pain or sleep disturbances, having had no change in prescription in the previous three months and be willing to make no other changes to medications 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

Критерии исключения

• 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 activity unsuitable (determined by a positive answer to the question: "Has a doctor or healthcare 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 cognitive screener).
• Presence of severe psychiatric disorder.
• Currently participating in an interventional trial or a pain or sleep management program 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 is not currently adequately treated, e.g., sleep apnea or narcolepsy.
• Currently meeting or exceeding physical activity guidance from the U.S. Department of Health and Human Services (noted in protocol)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT06580561 · HUM00241352 · 1R01AG081299-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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