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Идёт набор NCT06782347

Activating SilverSneakers Benefits for Seniors With Osteoarthritis

Без фазы С лечением Osteoarthritis Physical Inactivity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Proactive Care.
Кому может быть актуально
Состояния в реестре: Osteoarthritis, Physical Inactivity. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Activating SilverSneakers Benefits for Seniors With Osteoarthritis: Proactive Versus Usual Care

Обзор

The aim of this pragmatic randomized controlled trial is to test the effects of a brief proactive care intervention involving mailed material and two phone calls on: (1) increasing participation in SilverSneakers exercise programs among older adults with osteoarthritis; (2) improving physical, social and psychological outcomes identified as important to older adults with osteoarthritis; and (3) reducing costly osteoarthritis-related health service use. Approximately 1,454 older adults with osteoarthritis who have SilverSneakers access through their Medicare Advantage plan, but no prior SilverSneakers use, will be recruited to participate across the United States. Key outcome measures will be assessed over a two-year follow-up period.

Подробное описание

Exercise is an evidence-based strategy for managing osteoarthritis, but fewer than 15% of older adults exercise regularly. Lack of access to affordable fitness facilities and resources is often identified by older adults as a key barrier to regular exercise. However, more than half of U.S. older adults are enrolled in Medicare Advantage plans which include no-cost access to SilverSneakers or other similar exercise benefits. SilverSneakers benefits provide access to more than 15,000 fitness centers/gyms nationwide, and access to online- and in-person exercise classes taught at multiple fitness levels-all at no extra cost for older adults who are enrolled in participating Medicare Advantage plans. Remarkably, fewer than one-third of older adults use their insurance-covered SilverSneakers exercise benefits; with most unaware that they have access to these exercise benefits.

The investigators plan to conduct a pragmatic randomized controlled trial to compare the effects of Proactive Care, involving mailed material and phone calls plus a faxed information sheet for older adults' primary care providers, relative to Usual Care, involving the standard insurance-benefit information packet provided to older adults, on: (1) increasing participation in SilverSneakers exercise programs; (2) improving physical, social, and psychological outcomes identified as important to patients; and (3) reducing osteoarthritis-related health service use. Approximately 1,454 older adults who are enrolled in a Medicare Advantage plan at Humana and have no prior SilverSneakers use will be recruited across the United States. Participants will be followed over a 2-year period for key outcomes, with assessments conducted at baseline, 6, 12, and 24 months. Outcome measures will be obtained from Humana health claims databases and from self-report surveys.

The investigators hypothesize that, relative to the Usual Care group, the Proactive Care group will result in: (1) a greater proportion of participants who enroll in, and use SilverSneakers at least once; (2) a greater proportion of participants who use SilverSneakers at least one time per month at 2-year follow-up; and (3) greater mean improvements in physical functioning between baseline and 2-year follow-up. If these hypotheses are supported, and if proactive care procedures improve exercise participation and health outcomes and reduce costly health-service use, it could lead health insurers to adopt proactive care procedures more widely. Using proactive care procedures on a wider scale holds potential to help millions of older adults with osteoarthritis to access their insurance-covered exercise benefits, and improve the quality of their daily lives. Patient-, primary care-, community- and policy-level stakeholder partners will provide input throughout the project period to ensure the design, delivery and dissemination of proactive care procedures are patient-centered and incorporate diverse stakeholder perspectives.

Вмешательства

  • Поведенческое Proactive Care
    The proactive care intervention was designed to be similar to proactive care approaches used successfully in the tobacco control area. These proactive care procedures have not yet been adequately evaluated in the exercise promotion area.

Первичные конечные точки

  • Physical Function (subscale) [Срок оценки: Administered at baseline and at 6-, 12-, and 24-month follow-up; reported score for the primary outcome is the change between baseline and 24-month follow-up.]
  • SilverSneakers Activation [Срок оценки: Obtained from Humana health claims databases at baseline and at 6-, 12-, and 24-month follow-up; the number of participants who enrolled in SilverSneakers and used the benefit is calculated as a cumulative total across all assessment points.]
  • SilverSneakers Long-Term Participation Rate [Срок оценки: Obtained from Humana health claims databases at 12- and 24-month follow-up; primary outcome measured at 24-month follow-up.]
Вторичные конечные точки (12)
  • SilverSneakers Usage Frequency [Срок оценки: Obtained from Humana health claims databases at baseline and at 6-, 12-, and 24-month follow-up.]
  • SilverSneakers Interaction Mode [Срок оценки: Obtained from Humana health claims databases at baseline and at 6-, 12-, and 24-month follow-up.]
  • Moderate-to-Vigorous Physical Activity and Strength Training [Срок оценки: Administered at baseline and at 6-, 12-, and 24-month follow-up.]
  • Pain (subscale) [Срок оценки: Administered at baseline and at 6-, 12-, and 24-month follow-up.]
  • Fatigue [Срок оценки: Administered at baseline and at 6-, 12-, and 24-month follow-up.]
  • Depression [Срок оценки: Administered at baseline and at 6-, 12-, and 24-month follow-up.]
  • Loneliness [Срок оценки: Administered at baseline and at 6-, 12-, and 24-month follow-up.]
  • Satisfaction with Participation in Discretionary Social Activities [Срок оценки: Administered at baseline and at 6-, 12-, and 24-month follow-up.]
  • Social Networks [Срок оценки: Administered at baseline and at 6-, 12-, and 24-month follow-up.]
  • Spoke to Primary Care Provider about SilverSneakers [Срок оценки: Administered at 24-month follow-up.]
  • Number of Hip, Knee, or other Joint Replacement Surgeries [Срок оценки: Obtained from Humana medical claims databases at baseline and at 6-, 12-, and 24-month follow-up.]
  • Number of Arthroscopic Surgeries [Срок оценки: Obtained from Humana medical claims databases at baseline and at 6-, 12-, and 24-month follow-up.]

Критерии участия

Критерии включения

  • Aged 65 and older.
  • ICD-9 or ICD-10 code for hip, knee, or general osteoarthritis.
  • Positive response to a standardized question from the Medical Expenditure Panel Survey that asks if patient was diagnosed with osteoarthritis/arthritis and self-report confirmation of hip and/or knee pain due to their osteoarthritis/arthritis.
  • Continuous enrollment for at least one year in a Humana Medicare Advantage plan which provides free SilverSneakers access and both medical and prescription drug coverage.
  • Not currently or previously enrolled in SilverSneakers.
  • Speak English or Spanish.
  • Physical/mental capacity to provide informed consent, based on not having an ICD-9 or ICD-10 code for dementia and being able to answer three questions to verify comprehension of the informed consent form.

Критерии исключения

  • Another person in the same household is enrolling/enrolled in the study (to prevent treatment contamination, only one participant per household can participate).
  • Medicare/Medicaid dual enrollment due to limited data accessibility for this group.
  • Receiving hospice care or under long-term institutional care (Part C) due to limited data accessibility for this group.
  • Receiving care from a provider credentialed through a delegated arrangement (i.e., delegated provider), due to limited data accessibility for this group.
  • Lack of a valid mailing address in the Humana medical claims databases.

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
Двойное слепое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Penn State College of Medicine — Hershey

Идентификаторы

NCT: NCT06782347 · BPS-2022C3-30497

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗