Health Coaching + Incentives for Knee Osteoarthritis

(ReAKTIV Trial)

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

254 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The aims are to determine whether 1) an incentive based on behaviorally-enhanced gamification and social incentives and 2) health coaching can promote adherence to exercise and physical activity after physical therapy for osteoarthritis of the knee (KOA). The research design is a randomized clinical trial with factorial design This randomized clinical trial of 254 patients using a factorial design will leverage a clinical trial platform developed through the University of Pennsylvania that allows for the remotely capture important patient-reported outcomes and other interaction through a participant's smart phone. The investigators will randomize participants to receive social incentives with gamification to promote adherence to prescribed exercises as well as maintenance of greater levels of physical activity and compare to controls that receive a Fitbit but no additional incentive. Participants may also be randomized to receive a health coach. The investigators will utilize mobile applications for smart phones and wearable activity trackers through the Way-to-Health platform and assess, in real time, the impact of the interventions on patient-reported function and pain (as measured by the Knee Osteoarthritis Outcome Score) as well as physical activity. Participants will be followed for 2 years, with a total of 5 in-person visits. Knee osteoarthritis (KOA) is one of the most prevalent and disabling conditions among Veterans and accounts for high morbidity and high costs for the VA. Importantly, while physical therapy is valuable for patients with KOA, lack of adherence to home exercises and low overall physical activity limit the durability of response. The current proposal aims to address two important knowledge gaps in the management of KOA in order to improve pain and function.

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 health coaching and incentives for knee osteoarthritis safe for humans?

The studies reviewed focus on the effectiveness of health coaching, exercise, and weight loss for knee osteoarthritis, but they do not report any specific safety concerns related to these interventions. Generally, these types of interventions are considered safe for humans. ^{1 2 3 4 5}

How does the Remote Incentive Program treatment for knee osteoarthritis differ from other treatments?

The Remote Incentive Program for knee osteoarthritis is unique because it combines health coaching with incentives to motivate patients to manage their condition actively. This approach focuses on increasing motivation and self-efficacy (belief in one's ability to succeed) through personalized coaching, which is different from traditional treatments that may not emphasize behavioral changes and patient engagement. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Health coach, Remote Incentive Program for Knee Osteoarthritis?

Research shows that using technology to deliver financial incentives remotely can effectively change health-related behaviors, with 71% of studies reporting positive results. This suggests that similar incentive-based approaches could help engage patients with knee osteoarthritis in their treatment plans. ^{11 12 13 14 15}

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.

I am starting physical therapy for knee arthritis soon or started within the last week.

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

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]

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]

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]

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]

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]

Citations

1. Canada pubmed.ncbi.nlm.nih.gov

On supplementing "Foot in the door" incentives for eHealth program engagement. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A Review of the Literature on Remote Monitoring Technology in Incentive-Based Interventions for Health-Related Behavior Change. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of Patient Financial Incentives on Statin Adherence and Lipid Control: A Randomized Clinical Trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Should we pay the patient? Review of financial incentives to enhance patient compliance. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Behavioral economics holds potential to deliver better results for patients, insurers, and employers. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Better Knee, Better Me™: effectiveness of two scalable health care interventions supporting self-management for knee osteoarthritis - protocol for a randomized controlled trial. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of health coaching and financial incentives to promote physical activity after total knee replacement. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Protocol for a multi-center randomized controlled trial to evaluate the benefits of exercise incentives and corticosteroid injections in osteoarthritis of the knee (MOVE-OK). [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The Arthritis, Diet and Activity Promotion Trial (ADAPT): design, rationale, and baseline results. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Weight-loss and exercise for communities with arthritis in North Carolina (we-can): design and rationale of a pragmatic, assessor-blinded, randomized controlled trial. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

The impact of Telephonic Health Coaching on Health Outcomes in a High-risk Population. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Outcomes of a Digital Health Program With Human Coaching for Diabetes Risk Reduction in a Medicare Population. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

How effective is health coaching in reducing health services expenditures? [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Evaluating an insurer-based health coaching program: Impact of program engagement on healthcare utilization and weight loss. [2020]

15. Canada 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. [2019]