Recruiting

SilverSneakers

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT06782347

Conditions

Osteoarthritis

Physical Inactivity

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Proactive Care

Study Details

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.

Conditions

Osteoarthritis

Physical Inactivity

Study ID

NCT06782347

Start date

Jan 21, 2026

Status verified date

Feb, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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.
  • 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.

Study Design

Enrollment

1454 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Proactive Care

The Proactive Care condition will consist of one mailing to alert older adults to the existence of their SilverSneakers benefit, followed by two action-planning phone calls to prompt activation and use of the SilverSneakers exercise benefit. The action-planning calls will guide older adults through an action plan to enroll in SilverSneakers, and choose convenient joint-friendly SilverSneakers exercise options appropriate for their fitness level. Exercise options are available both in-person and online. Older adults will also be given the option to have an information sheet about SilverSneakers sent to their primary care providers to encourage further discussion about SilverSneakers.

no intervention: Usual Care

The Usual Care condition will include the standard information provided to Medicare Advantage beneficiaries about SilverSneakers.

Interventions

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.

Primary outcome measure

  • Physical Function (subscale) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Obtained from Humana health claims databases at 12- and 24-month follow-up; primary outcome measured at 24-month follow-up. ]

Central Contacts and Locations

Central contacts

Liza S. Rovniak, PhD, MPH

717-531-8161lrovniak@pennstatehealth.psu.edu

Locations

Penn State College of Medicine

Recruiting

Hershey, Pennsylvania, United States, 17033

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2026-02-10.