Activating SilverSneakers Benefits for Seniors With Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorMilton S. Hershey Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Proactive Care
BehavioralThe 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.
Treatment groups
1,454 Participants
are divided into 2 treatment groupsGroup A: Proactive CareOther 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
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.
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.2
SilverSneakers Activation
Number of participants who enrolled in SilverSneakers and used their SilverSneakers benefit at least one time.
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.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.
Time frame
Obtained from Humana health claims databases at 12- and 24-month follow-up; primary outcome measured at 24-month follow-up.Secondary outcomes
1
SilverSneakers Usage Frequency
Number of times per month participant used their SilverSneakers benefit.
Time frame
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.
Time frame
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.
Time frame
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.
Time frame
Administered at baseline and at 6-, 12-, and 24-month follow-up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Milton S. Hershey Medical Center
Lead sponsor
Humana Healthcare Research
Collaborator
Kaiser Permanente
Collaborator
Global Healthy Living Foundation
Collaborator
Patient-Centered Outcomes Research Institute
Collaborator
CVS Healthspire Life Sciences Solutions
Collaborator
Tivity Health
Collaborator
Source ClinicalTrials.gov