NCT06782347

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,454

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Jul 2028

First Submitted

Initial submission to the registry

June 25, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
1 year until next milestone

Study Start

First participant enrolled

January 21, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

2.4 years

First QC Date

June 25, 2024

Last Update Submit

February 7, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

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

    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

    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.

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

Secondary Outcomes (19)

  • SilverSneakers Usage Frequency

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

  • SilverSneakers Interaction Mode

    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

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

  • Pain (subscale)

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

  • Fatigue

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

  • +14 more secondary outcomes

Study Arms (2)

Proactive Care

OTHER

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.

Behavioral: Proactive Care

Usual Care

NO INTERVENTION

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

Interventions

Proactive CareBEHAVIORAL

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.

Proactive Care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

RECRUITING

MeSH Terms

Conditions

OsteoarthritisSedentary Behavior

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Liza S. Rovniak, PhD, MPH

    Penn State College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liza S. Rovniak, PhD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine and Public Health Sciences

Study Record Dates

First Submitted

June 25, 2024

First Posted

January 17, 2025

Study Start

January 21, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations