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OsteoarthritisNCT06782347

Activating SilverSneakers Benefits for Seniors With Osteoarthritis

A study testing Proactive Care in people with Osteoarthritis and Physical Inactivity, run by Milton S. Hershey Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Osteoarthritis, Physical Inactivity
What is being tested?
Proactive Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,454 participants
Where
1 siteUnited States
Study dates
21 Jan 2026to Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Liza S. Rovniak, PhD, MPH contact

717-531-8161

lrovniak@pennstatehealth.psu.edu

United States1 site, 1 recruiting
  • Penn State College of Medicine

    Hershey, Pennsylvania, 17033

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Proactive Care
Medical subject headings
Osteoarthritis, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proactive CareBehavioural

    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.

Study groups in NCT06782347
Study groupRoleWhat they receive
Proactive CareOtherThe 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.
Receives: Behavioral: Proactive Care
Usual CareNo interventionThe Usual Care condition will include the standard information provided to Medicare Advantage beneficiaries about SilverSneakers.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical Function (subscale)

    This measure is a subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC); items measure ability to perform activities of daily living. Each item is scored on a 5-point Likert scale ranging from None (0) to Extreme (4). The scores are summed, with a possible score range of 0 to 68 for the Physical Function subscale. Higher scores indicate worse functional limitations.

    Measured: 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.

  2. SilverSneakers Activation

    Number of participants who enrolled in SilverSneakers and used their SilverSneakers benefit at least one time.

    Measured: 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.

  3. SilverSneakers Long-Term Participation Rate

    Of those participants who enrolled in SilverSneakers and used their SilverSneakers benefit at least once, the number who are still using their SilverSneakers benefit ≥1 time/month at 24-month follow-up.

    Measured: Obtained from Humana health claims databases at 12- and 24-month follow-up; primary outcome measured at 24-month follow-up.

Secondary outcomes (19)
  1. SilverSneakers Usage Frequency

    Number of times per month participant used their SilverSneakers benefit.

    Measured: Obtained from Humana health claims databases at baseline and at 6-, 12-, and 24-month follow-up.

  2. SilverSneakers Interaction Mode

    The interaction mode (e.g., in-person, online) of participants' SilverSneakers exercise activities.

    Measured: Obtained from Humana health claims databases at baseline and at 6-, 12-, and 24-month follow-up.

  3. Moderate-to-Vigorous Physical Activity and Strength Training

    Three questions from the National Health Interview Survey will assess the proportion of participants meeting national physical activity guidelines. Participants will be asked how many times per week they do leisure-time vigorous activities, light or moderate activities, and strength training. Scores range from 0 to 7 times per week with a higher score (more times per week) indicating better adherence to physical activity guidelines.

    Measured: Administered at baseline and at 6-, 12-, and 24-month follow-up.

  4. Pain (subscale)

    This measure is a subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC); items measure hip and knee pain while in motion and at rest. Each item is scored on a 5-point Likert scale ranging from None (0) to Extreme (4). The scores are summed, with a possible score range of 0 to 20 for the Pain subscale. Higher scores indicate worse pain.

    Measured: Administered at baseline and at 6-, 12-, and 24-month follow-up.

  5. Fatigue

    Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-short form. Each item is scored on a 5-point Likert scale ranging from Never (1) to Always (5). The scores are summed, with a possible score range of 7 to 35. Higher scores indicate greater fatigue.

    Measured: Administered at baseline and at 6-, 12-, and 24-month follow-up.

  6. Depression

    Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-short form. Each item is scored on a 5-point Likert scale ranging from Never (1) to Always (5). The scores are summed, with a possible score range of 8 to 40. Higher scores indicate greater severity of depression.

    Measured: Administered at baseline and at 6-, 12-, and 24-month follow-up.

  7. Loneliness

    Assessed by UCLA Brief Loneliness Scale. Each item is scored on a 3-point Likert scale ranging from Hardly Ever (1) to Often (3). The scores are summed, with a possible score range of 3 to 9. Higher scores indicate greater loneliness.

    Measured: Administered at baseline and at 6-, 12-, and 24-month follow-up.

  8. Satisfaction with Participation in Discretionary Social Activities

    Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-short form. Each item is scored on a 5-point Likert scale ranging from Not at All (1) to Very Much (5). The scores are summed, with a possible score range of 7 to 35. Higher scores indicate greater satisfaction with participation in discretionary social activities.

    Measured: Administered at baseline and at 6-, 12-, and 24-month follow-up.

  9. Social Networks

    Assessed by Berkman-Syme Social Network Index; items measure different components of social networks including marital status, number of close friends and relatives, membership in community/recreational organizations, and participation in religious services. Scores are summed across the different types of social network connections and range from 1 to 4. Higher scores indicate greater social connectedness.

    Measured: Administered at baseline and at 6-, 12-, and 24-month follow-up.

  10. Spoke to Primary Care Provider about SilverSneakers

    Reported question asking if participant ever spoke to primary care provider about SilverSneakers.

    Measured: Administered at 24-month follow-up.

  11. Number of Hip, Knee, or other Joint Replacement Surgeries

    Surgical procedures will be identified using Current Procedural Terminology (CPT) codes, Diagnosis-Related Group (DRG) codes, and International Classification of Diseases procedure codes (ICD Px).

    Measured: Obtained from Humana medical claims databases at baseline and at 6-, 12-, and 24-month follow-up.

  12. Number of Arthroscopic Surgeries

    Surgical procedures will be identified using CPT, DRG, and ICD Px codes.

    Measured: Obtained from Humana medical claims databases at baseline and at 6-, 12-, and 24-month follow-up.

  13. Number of Inpatient Hospital Visits and Emergency Department Visits

    Visits will be identified using bill types, revenue codes, and Place of Treatment (POT).

    Measured: Obtained from Humana medical claims databases at baseline and at 6-, 12-, and 24-month follow-up.

  14. Number of Fall-Related Injuries Requiring Medical Care

    Fall-related injuries will be determined based on the presence of ICD Px injury codes for moderate to severe injuries (excluding non-fall-related injuries) and fall-related E-codes.

    Measured: Obtained from Humana medical claims databases at baseline and at 6-, 12-, and 24-month follow-up.

  15. Number of Outpatient Primary Care, Specialist, and Physiotherapy Visits

    Visits will be identified using POT, revenue codes, CPT codes, Healthcare Common Procedure Coding System (HCPCS) codes and modifiers.

    Measured: Obtained from Humana medical claims databases at baseline and at 6-, 12-, and 24-month follow-up.

  16. Number of Radiography/Imaging Procedures

    These procedures will be identified using CPT codes, HCPCS codes, and revenue codes.

    Measured: Obtained from Humana medical claims databases at baseline and at 6-, 12-, and 24-month follow-up.

  17. Number of Joint Injections (e.g., corticosteroids, hyaluronic acid)

    These injections will be identified using CPT codes, HCPCS codes, and HCPCS J-codes.

    Measured: Obtained from Humana medical claims databases at baseline and at 6-, 12-, and 24-month follow-up.

  18. Analgesic/NSAID Drug Use

    Drug names (separately for branded vs. generic) will be obtained for prescription drugs.

    Measured: Obtained from Humana medical claims databases at baseline and at 6-, 12-, and 24-month follow-up.

  19. Estimated Healthcare Costs

    Total estimated healthcare costs for the health service categories described above will be computed using health service data from the Humana health claims databases and cost data from the www.cms.gov cost sites.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2025
  2. Study start21 Jan 2026
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
1,454 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06782347
Sponsor's protocol ID
BPS-2022C3-30497
Status last verified
Feb 2026
First submitted
25 Jun 2024
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Proactive Care in people with Osteoarthritis and Physical Inactivity, run by Milton S. Hershey Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liza S. Rovniak, PhD, MPH (717-531-8161, lrovniak@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

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