Clinical trial NCT06782347: Activating SilverSneakers Benefits for Seniors With Osteoarthritis
Official title: Activating SilverSneakers Benefits for Seniors With Osteoarthritis: Proactive Versus Usual Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoarthritis
Physical Inactivity
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Humana Healthcare Research
name: Kaiser Permanente
name: Global Healthy Living Foundation
name: Patient-Centered Outcomes Research Institute
name: CVS Healthspire Life Sciences Solutions
name: Tivity Health
First posted: 2025-01-17
Enrollment: 1454
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Physical Function (subscale)
timeFrame: 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.
measure: SilverSneakers Activation
timeFrame: 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.
measure: SilverSneakers Long-Term Participation Rate
timeFrame: Obtained from Humana health claims databases at 12- and 24-month follow-up; primary outcome measured at 24-month follow-up.
Secondary outcomes:
measure: SilverSneakers Usage Frequency
timeFrame: Obtained from Humana health claims databases at baseline and at 6-, 12-, and 24-month follow-up.
measure: SilverSneakers Interaction Mode
timeFrame: Obtained from Humana health claims databases at baseline and at 6-, 12-, and 24-month follow-up.
measure: Moderate-to-Vigorous Physical Activity and Strength Training
timeFrame: Administered at baseline and at 6-, 12-, and 24-month follow-up.
measure: Pain (subscale)
timeFrame: Administered at baseline and at 6-, 12-, and 24-month follow-up.
measure: Fatigue
timeFrame: Administered at baseline and at 6-, 12-, and 24-month follow-up.
measure: Depression
timeFrame: Administered at baseline and at 6-, 12-, and 24-month follow-up.
measure: Loneliness
timeFrame: Administered at baseline and at 6-, 12-, and 24-month follow-up.
measure: Satisfaction with Participation in Discretionary Social Activities
timeFrame: Administered at baseline and at 6-, 12-, and 24-month follow-up.
measure: Social Networks
timeFrame: Administered at baseline and at 6-, 12-, and 24-month follow-up.
measure: Spoke to Primary Care Provider about SilverSneakers
timeFrame: Administered at 24-month follow-up.
measure: Number of Hip, Knee, or other Joint Replacement Surgeries
timeFrame: Obtained from Humana health claims databases at baseline and at 6-, 12-, and 24-month follow-up.
measure: Number of Arthroscopic Surgeries
timeFrame: Obtained from Humana health claims databases at baseline and at 6-, 12-, and 24-month follow-up.
measure: Number of Inpatient Hospital Visits and Emergency Department Visits
timeFrame: Obtained from Humana health claims databases at baseline and at 6-, 12-, and 24-month follow-up.
measure: Number of Fall-Related Injuries Requiring Medical Care
timeFrame: Obtained from Humana health claims databases at baseline and at 6-, 12-, and 24-month follow-up.
measure: Number of Outpatient Primary Care, Specialist, and Physiotherapy Visits
timeFrame: Obtained from Humana health claims databases at baseline and at 6-, 12-, and 24-month follow-up.
measure: Number of Radiography/Imaging Procedures
timeFrame: Obtained from Humana health claims databases at baseline and at 6-, 12-, and 24-month follow-up.
measure: Number of Joint Injections (e.g., corticosteroids, hyaluronic acid)
timeFrame: Obtained from Humana health claims databases at baseline and at 6-, 12-, and 24-month follow-up.
measure: Analgesic/NSAID Drug Use
timeFrame: Obtained from Humana health claims databases at baseline and at 6-, 12-, and 24-month follow-up.
measure: Estimated Healthcare Costs
timeFrame: Health service and cost data will be obtained at baseline (the baseline measurement will include the 1-year period prior to proactive care delivery) and at 6-, 12-, and 24-month follow-up.
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Liza S. Rovniak, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: