Health Coaching + Incentives for Knee Osteoarthritis

(ReAKTIV Trial)

Not yet recruiting at 4 trial locations

Overseen By Joshua F Baker, MD MSCE

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: VA Office of Research and Development

Disqualifiers: Inflammatory arthritis, Severe heart failure, Pregnancy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help individuals maintain exercise routines after physical therapy for knee osteoarthritis (KOA). It examines whether a fun, game-like system (Remote Incentive Program) or support from a health coach can facilitate staying active and reducing pain. Participants will use a smartphone app and a fitness tracker to evaluate these methods over two years. This trial may suit those who have recently begun physical therapy for KOA, own a smartphone, and can walk at least two blocks unassisted. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for KOA.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on exercise and physical activity, so it's best to discuss your medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have shown that health coaching helps reduce disability and pain in people with knee osteoarthritis. This indicates it is generally safe and well-tolerated, with no major side effects reported, suggesting that health coaching usually doesn't cause harm.

Research shows that using smartphone apps and activity trackers in remote incentive programs is safe and effective for people with knee osteoarthritis. These tools have helped patients exercise more and improve knee function, with no serious safety issues reported.

Overall, both health coaching and remote incentive programs appear to be safe ways to support people with knee osteoarthritis. Previous studies have tested them without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial for knee osteoarthritis because it explores how combining health coaching with an incentive program might enhance patient outcomes. Unlike standard treatments like pain relievers and physical therapy, this approach focuses on behavior change and motivation, aiming to empower patients to manage their condition more effectively. By testing variations with and without coaching and incentives, researchers hope to pinpoint what combination best supports patients in improving their mobility and reducing pain. This trial could lead to innovative, non-invasive strategies that complement existing medical treatments, offering a holistic approach to managing osteoarthritis.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

Research has shown that health coaching, which participants in this trial may receive, can help reduce disability and pain in people with knee osteoarthritis. Reviews of multiple studies indicate that those who receive health coaching experience improved movement and quality of life. Additionally, studies on remote incentive programs, another treatment option in this trial, reveal significant reductions in knee pain and improvements in knee function. Specifically, one study found that participants reported better knee function after using remote exercise programs. These findings suggest that both health coaching and remote incentives, tested in different arms of this trial, may help manage knee osteoarthritis symptoms by encouraging regular exercise and physical activity. ^{1 2 6 7 8}

Who Is on the Research Team?

Joshua Baker, MD

Principal Investigator

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Are You a Good Fit for This Trial?

This trial is for veterans with knee osteoarthritis who have completed physical therapy. It's designed to help them stick to their exercise routines and stay active. Participants need a smartphone to use the study apps and trackers, but can't join if they have conditions that interfere with following the program.

Inclusion Criteria

PT feels that they are able to safely and reliably participate in ongoing exercise

I have been diagnosed with chronic knee osteoarthritis.

Must sync their Fitbit at least monthly

Exclusion Criteria

Treating provider or LSI believes life-expectancy is less than 1 year

I do not have severe heart, kidney, lung diseases, or other chronic illnesses that limit my ability to exercise.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Standard Physical Therapy

Participants undergo 6-8 weeks of supervised physical therapy including strengthening and mobility training

6-8 weeks

Intervention

Participants receive a remotely-applied behavioral intervention and/or health coaching to promote adherence to exercises and physical activity

Up to 18 months

5 in-person visits

Follow-up

Participants are monitored for safety and effectiveness after the intervention

6-18 months

What Are the Treatments Tested in This Trial?

Interventions

• Health coach
• Remote Incentive Program

Trial Overview

The study tests whether incentives like games and social rewards, along with health coaching, can keep patients on track with exercises after physical therapy. Using smart technology, it compares these methods against standard care over two years.

How Is the Trial Designed?

Group I: No Health Coach, Receives Incentives Experimental Treatment 1 Intervention

Does not receive a health coach but does receive the incentive program.

Group II: Health Coaching, Receives Incentives Experimental Treatment 2 Interventions

Receives both a health coach and the incentive program

Group III: Health Coaching, No Incentives Experimental Treatment 1 Intervention

Receives a Health Coach but no Incentive Program

Group IV: No Intervention Active Control 1 Intervention

Neither Intervention

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Telephonic Health Coaching combined with Financial Incentives (THC + FI) is potentially cost-effective for promoting physical activity in total knee replacement patients, with an Incremental Cost-Effectiveness Ratio (ICER) of $57,200 per Quality-Adjusted Life Year (QALY), which is below the $100,000/QALY threshold considered cost-effective.

The cost-effectiveness of THC + FI is sensitive to its long-term efficacy; if the benefits are limited to 1 year or 9 months, the ICER increases significantly, indicating that further research is needed to clarify its long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of health coaching and financial incentives to promote physical activity after total knee replacement. Smith, KC., Paltiel, AD., Yang, HY., et al.[2019]

The Arthritis, Diet, and Activity Promotion Trial (ADAPT) involved 316 sedentary, overweight, and obese older adults with knee osteoarthritis, testing the effects of lifestyle changes over 18 months on physical function and pain.

The study aims to identify effective behavioral therapies that can help reduce disability from knee OA, focusing on interventions like dietary weight loss and structured exercise, which are based on established psychological principles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Arthritis, Diet and Activity Promotion Trial (ADAPT): design, rationale, and baseline results. Miller, GD., Rejeski, WJ., Williamson, JD., et al.[2019]

Many incentive programs aimed at improving patient self-care are unlikely to be effective because they rely on patients having the necessary information, expertise, and self-control, which many do not possess.

Incorporating behavioral economics insights, such as providing small, frequent payments for positive health behaviors like medication adherence, can enhance the effectiveness of these programs and improve patient engagement, benefiting both patients and insurers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral economics holds potential to deliver better results for patients, insurers, and employers. Loewenstein, G., Asch, DA., Volpp, KG.[2022]

In a study involving 501 Medicare participants at risk for diabetes, those who engaged in a program combining digital health and human coaching achieved a significant average weight loss of 7.5% over 12 months.

Participants also showed improvements in glucose control (decreased HbA1c by -0.14%) and total cholesterol levels, along with enhanced self-reported well-being and self-care, indicating the program's effectiveness in reducing chronic disease risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a Digital Health Program With Human Coaching for Diabetes Risk Reduction in a Medicare Population. Castro Sweet, CM., Chiguluri, V., Gumpina, R., et al.[2022]

Health coaching significantly reduced outpatient and total healthcare expenditures for high-risk participants, with estimated savings of $286 and $412 per person per month, respectively.

While health coaching did not impact emergency room costs, it did lead to a significant decrease in the probability of incurring inpatient expenditures, highlighting its potential effectiveness in managing healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How effective is health coaching in reducing health services expenditures? Jonk, Y., Lawson, K., O'Connor, H., et al.[2022]

In a study of 225 participants in a telephonic health coaching program, those who engaged in at least 6 coaching sessions experienced a significant average weight loss of -3.5%, compared to a modest overall weight change of -2.1% for the group.

Despite the focus on weight management, the study found no significant changes in healthcare utilization or costs associated with program engagement, suggesting that while coaching can aid weight loss, it may not impact healthcare visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating an insurer-based health coaching program: Impact of program engagement on healthcare utilization and weight loss. Reid, N., Bennett, W., Coughlin, J., et al.[2020]

In a study involving 763 overweight participants using a mobile phone-based health coaching service for 4 months, participants lost an average of 3.23% of their total body weight, with 28.6% achieving a clinically significant weight loss of 5% or more.

Among participants with high blood pressure, nearly half (49.1%) improved their blood pressure by an entire hypertensive stage after 4 months of coaching, indicating that digital health coaching can effectively support both weight loss and blood pressure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Phone-Based Health Coaching Intervention for Weight Loss and Blood Pressure Reduction in a National Payer Population: A Retrospective Study. Mao, AY., Chen, C., Magana, C., et al.[2019]

A randomized clinical trial involving 805 participants showed that various financial incentives significantly improved adherence to statin medication compared to a control group, with adherence rates reaching up to 87% in incentive groups.

Despite improved adherence, the study found no significant reduction in LDL-C levels among the incentive groups compared to the control, highlighting the need to measure actual health outcomes rather than just medication adherence in such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Patient Financial Incentives on Statin Adherence and Lipid Control: A Randomized Clinical Trial. Barankay, I., Reese, PP., Putt, ME., et al.[2021]

Health coaching significantly improved various health outcomes, including stress levels, healthy eating, exercise, and overall quality of life, with 89% of participants achieving at least one health goal within 6 months.

Despite only 7% of eligible candidates participating, those with higher chronic disease burdens were more likely to engage, indicating that health coaching may be particularly beneficial for individuals with complex health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of Telephonic Health Coaching on Health Outcomes in a High-risk Population. Lawson, KL., Jonk, Y., O'Connor, H., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9825146/

Health Coaching for Low Back Pain and Hip and Knee ...

Meta-analyses provide evidence that health coaching reduces both disability and pain in people with chronic LBP and reduces disability in people with knee OA.

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bmcmusculoskeletdisord.biomedcentral.com

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The aim of this study is to analyze the effectiveness, cost-effectiveness and cost-utility of a health coaching intervention on quality of life, ...

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sciencedirect.com

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Training of Peer Coaches to Assist Individuals with Knee ...

The objective of this study is to outline the training of peer coaches in the Moving Well intervention, which was designed to reduce anxiety, depression, and ...

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isrctn.com

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The main aim of the study is to assess the effectiveness, cost-effectiveness and cost-utility of an intervention based on Health Coaching with support phone ...

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sciencedirect.com

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Health coaching improves physical activity, disability and ...

Health coaching had a small effect on improving disability (19 trials; SMD 0.25, 95% CI 0.17 to 0.32; moderate certainty evidence) and pain (19 trials; SMD 0.31 ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT07219732

Boosting Exercise Adherence in Knee Osteoarthritis

Specifically, BOOST-OA includes: 1) Tools and activities woven into PT visits that address outcome expectations, action self-efficacy, goal- ...