Proactive Care for Osteoarthritis

Overseen By Marielena De Araujo-Greecher, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Dual enrollment, Hospice, Institutional care

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a proactive care approach to help older adults with osteoarthritis become active by using their SilverSneakers exercise benefit. It involves sending information by mail and making two phone calls to encourage participation in exercise programs, aiming to improve physical, social, and mental well-being. The researchers aim to reduce the need for costly healthcare services related to osteoarthritis. The trial seeks older adults diagnosed with osteoarthritis who experience hip or knee pain and have not yet used their SilverSneakers benefits. As an unphased trial, it offers a unique opportunity for participants to enhance their well-being through personalized support and exercise programs.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on exercise participation, so it's likely you can continue your medications, but please confirm with the trial organizers.

What prior data suggests that this proactive care intervention is safe for older adults with osteoarthritis?

Research shows that the proactive care treatment involves mailing information and making two phone calls to encourage seniors with osteoarthritis to use their SilverSneakers exercise benefits. This approach provides guidance and motivation to stay active, which is important for managing osteoarthritis.

Since this trial promotes exercise, it does not involve new drugs or medical procedures. The proactive care treatment is generally considered safe because it centers on communication and planning. Previous studies using similar methods have not reported negative effects. Encouraging exercise, especially with programs like SilverSneakers, is usually well-tolerated and beneficial for overall health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Proactive Care approach for osteoarthritis because it's all about empowering older adults to take advantage of their SilverSneakers fitness benefit. Unlike typical treatments focused on medications or physical therapy, Proactive Care involves personalized action-planning phone calls and information mailings, encouraging participants to actively enroll and engage in joint-friendly exercises. This method not only aims to improve physical activity but also involves their primary care providers, fostering a more holistic approach to managing osteoarthritis. By integrating exercise into daily life, Proactive Care could offer a more accessible and sustainable way to manage symptoms and improve quality of life.

What evidence suggests that this proactive care intervention is effective for osteoarthritis?

Research has shown that encouraging older adults with osteoarthritis to use their SilverSneakers exercise benefits can increase their activity levels. Currently, only about 21% of seniors with osteoarthritis utilize these benefits. This trial will compare two approaches: the Usual Care arm, which provides standard information to Medicare Advantage beneficiaries about SilverSneakers, and the Proactive Care arm, which involves sending information and making phone calls to boost participation. Increased activity is linked to better physical, social, and mental health for those with osteoarthritis. Additionally, frequent participation in exercise programs can reduce the need for costly health services related to osteoarthritis. The study aims to enhance these positive effects by encouraging seniors to use their exercise benefits. ^{1 2 3 4 6}

Who Is on the Research Team?

Liza S. Rovniak, PhD, MPH

Principal Investigator

Penn State College of Medicine

Are You a Good Fit for This Trial?

This trial is for older adults with osteoarthritis who have access to SilverSneakers through Medicare Advantage but haven't used it. The study aims to engage these individuals in exercise programs to improve their physical, social, and psychological well-being while reducing healthcare costs related to osteoarthritis.

Inclusion Criteria

I have been diagnosed with osteoarthritis in my hip, knee, or another joint.

I understand the consent form and do not have dementia.

I am 65 years old or older.

Exclusion Criteria

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

I have not had major surgery in the last month and do not plan any that will limit my physical activity in the next year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Proactive Care Intervention

Participants receive mailed material and two phone calls to activate SilverSneakers benefits

6 months

2 phone calls

Follow-up

Participants are monitored for SilverSneakers participation and health outcomes

24 months

Assessments at baseline, 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Proactive Care

Trial Overview The trial is testing a proactive care intervention that includes sending materials by mail and making two phone calls, aiming to increase participation in SilverSneakers exercise programs among seniors with osteoarthritis.

How Is the Trial Designed?

Group I: Proactive Care Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

Humana Healthcare Research

Collaborator

Trials

1

Recruited

1,500+

Global Healthy Living Foundation

Collaborator

Trials

6

Recruited

46,600+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

CVS Healthspire Life Sciences Solutions

Collaborator

Trials

1

Recruited

1,500+

Tivity Health

Collaborator

Trials

1

Recruited

1,500+

Published Research Related to This Trial

In a study of 143 patients with rheumatoid arthritis (RA) and osteoarthritis (OA), 35.7% experienced adverse drug events (ADEs), highlighting the commonality of these events in patients taking medications for these conditions.

Most ADEs were linked to disease-modifying anti-rheumatic drugs (59.4%) and non-steroidal anti-inflammatory drugs (14.5%), with 44.1% of the ADEs deemed preventable, indicating a need for better monitoring and management of drug safety in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events in rheumatoid arthritis and osteoarthritis ambulatory patients. Tragulpiankit, P., Chulavatnatol, S., Rerkpattanapipat, T., et al.[2012]

In a 10-week study involving 164 patients undergoing elective orthopedic procedures, independent clinical reviewers identified significantly more adverse events (99) compared to surgeons (14), highlighting a gap in surgeons' reporting practices.

While surgeons effectively captured major adverse events, they missed many minor events that were documented by reviewers, suggesting that using standardized assessment tools like SAVES V2 and OrthoSAVES could enhance overall adverse-event reporting in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Surgeons Adequately Capture Adverse Events Using the Spinal Adverse Events Severity System (SAVES) and OrthoSAVES? Chen, BP., Garland, K., Roffey, DM., et al.[2018]

The PROSPER Consortium aims to enhance safety reporting in healthcare by integrating patient-reported outcomes (PROs) into the assessment of adverse events, recognizing the importance of the patient's perspective in understanding treatment effects.

Despite advancements in technology and increased focus on patient involvement, current safety reporting still heavily relies on healthcare professionals, which can lead to under-reporting and discrepancies between patient experiences and clinician perceptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance. Banerjee, AK., Okun, S., Edwards, IR., et al.[2022]

Patients with osteoarthritis who participated in a new integrated multidisciplinary outpatient program reported significantly higher satisfaction with their healthcare compared to those receiving usual care, with a mean difference of -1.05 on a satisfaction scale after 4 months.

While the multidisciplinary program improved self-efficacy regarding symptoms, it did not lead to clinically relevant improvements in health outcomes, and some pain and fatigue scores worsened at 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an Integrated Multidisciplinary Osteoarthritis Outpatient Program versus Outpatient Clinic as Usual: A Randomized Controlled Trial. Moe, RH., Grotle, M., Kjeken, I., et al.[2016]

In a study of 2,146 patients undergoing elective knee, hip, and spine surgeries for degenerative conditions, the overall adverse event rate was 27%, with spinal surgeries having the highest rate of severe adverse events.

Key risk factors for adverse events included increasing age, male sex, longer operative duration, longer hospital stays, and undergoing revision surgery, highlighting the need for careful patient assessment and procedural efficiency improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated with Adverse Events in Inpatient Elective Spine, Knee, and Hip Orthopaedic Surgery. Millstone, DB., Perruccio, AV., Badley, EM., et al.[2017]

The intervention involving workshops for general practitioners and physiotherapists led to a small, non-significant increase in the quality of care for patients with hip and knee osteoarthritis, particularly in providing information about treatment options and self-management strategies.

Patients reported higher odds of receiving information on treatment alternatives and self-management after the intervention, indicating improved communication and education, although there were minimal changes in referral practices and imaging use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving osteoarthritis management in primary healthcare: results from a quasi-experimental study. Østerås, N., Blaker, IB., Hjortland, T., et al.[2021]

The implementation of the SAMBA model for integrated osteoarthritis care in primary care settings significantly improved patient-reported quality of care and satisfaction, with scores rising from 41 to 60 on a quality indicator scale among 393 patients studied.

Patients receiving the intervention were more likely to be referred to physiotherapy and meet physical activity recommendations, while fewer were referred to orthopedic surgeons, indicating a more effective management of osteoarthritis compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a structured model for osteoarthritis care in primary healthcare: A stepped-wedge cluster-randomised trial. Østerås, N., Moseng, T., van Bodegom-Vos, L., et al.[2021]

Citations

1. pcori.org pcori.org/research-results/2023/comparing-effectiveness-two-outreach-approaches-promote-use-insurance-covered-exercise-benefits-among-older-adults-osteoarthritis

Comparing the Effectiveness of Two Outreach Approaches ... This study compares the effectiveness of two outreach approaches to promote use of insurance-covered SilverSneakers exercise benefits for ...

2. pure.psu.edu pure.psu.edu/en/projects/activating-silversneakers-benefits-for-seniors-with-osteoarthriti

Activating SilverSneakers Benefits for Seniors with ... However, only about 21% of seniors with osteoarthritis use their SilverSneakers benefits, and fewer than 15% engage in other structured exercise. Previous ...

3. trials.arthritis.org trials.arthritis.org/trials/NCT06782347

Activating SilverSneakers Benefits for Seniors With Osteoarthritis ... Outcome measures will be obtained from Humana health claims databases and from self-report surveys. The investigators hypothesize that, relative to the Usual ...

4. smartpatients.com smartpatients.com/trials/NCT06782347

Activating SilverSneakers Benefits for Seniors With ... 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 ...

5. openreview.net openreview.net/pdf?id=qjY8a8jRgy

Enhancing Patient Recruitment Response in Clinical Trials A PCORI-funded clinical trial investigates the health and social effect of proactively utilizing the “SilverSneakers”, an insurance-covered exercise program, ...

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0056529

Osteoarthritis (OA) (DBCOND0056529) Associated Data ; NCT00314652. Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain. Buprenorphine.