Activity Tracker + Motivational Coaching for Knee Replacement Recovery

(KArAT Trial)

Recruiting at 6 trial locations

Overseen By Scott R Nodzo, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Dementia, Epilepsy, Diabetes, others

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

Compensation: Varies

Number of Visits: 10

Duration: 32 weeks

600 Participants Needed

Trial Summary

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's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for knee replacement recovery?

Motivational Interviewing (MI) has been shown to be effective in helping people make health-related changes, such as quitting smoking and increasing exercise, by enhancing motivation and commitment. This approach, which is part of the treatment, could similarly support recovery after knee replacement by encouraging patients to engage in beneficial behaviors. ^{1 2 3 4 5}

Is the combination of motivational interviewing and wearable activity trackers safe for humans?

Research on motivational interviewing and wearable activity trackers suggests they are generally safe for humans. These interventions have been used in various studies without reports of harm, focusing on improving motivation and physical activity. ^{5 6 7 8 9}

How does the treatment of Activity Tracker + Motivational Coaching for Knee Replacement Recovery differ from other treatments?

This treatment is unique because it combines the use of an activity tracker with motivational coaching to enhance physical activity and recovery after knee replacement surgery. Unlike traditional methods, it focuses on increasing adherence to exercise through personalized feedback and motivation, which can lead to better recovery outcomes. ^{10 11 12 13 14}

What is the purpose of this trial?

Total knee replacement (TKR) is a common and costly procedure widely used to relieve pain and improve function in patients with symptomatic advanced knee osteoarthritis (OA). As of 2013, the annual incidence of TKR was over 680,000 surgeries and annual costs exceeded $11 billion. Growing evidence suggests that while pain and functional status improve following TKR, physical activity (PA) typically does not surpass pre-TKR levels. Engagement in PA can meaningfully improve quality of life (QoL), pain, and function. Given the large investment in TKR, the effectiveness and cost-effectiveness of TKR could be substantially increased if TKR recipients became more physically active. The Knee Arthroplasty Activity Trial (KArAT) is a randomized controlled trial and participants will be randomly assigned to one of three arms. Participants across all arms will receive usual post-operative care for TKR surgery. Participants in the first arm will complete basic study activities, such as responding to surveys and attending two in-person clinic visits. Participants in the second arm will do the same and also receive a wrist-based physical activity tracker intervention. Participants in the third arm will receive a telephonic active coaching (motivational interviewing) and financial incentives (for reaching physical activity goals) (TAC(MI)+FI) based intervention, as well as a wrist-based physical activity tracker intervention. The second and third arms will be eligible to receive lottery-based financial rewards for wearing a wrist-worn activity tracker for twenty-four months during the study.

Research Team

Elena Losina, Ph.D., M.Sc.

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for English-speaking adults aged 40-85 with osteoarthritis, scheduled for knee replacement surgery at one of the recruitment centers. Participants must be able to wear an activity tracker for most of the week and have access to a device for syncing this data. Exclusions include dementia, certain inflammatory diseases, wheelchair users, upcoming musculoskeletal surgeries within six months after TKR, or any psychological issues affecting participation.

Inclusion Criteria

I am between 40 and 85 years old.

English-speaking

During an accelerometer run-in period lasting one week at baseline (prior to surgery), subjects must show that they can comply with waist-worn physical activity tracker protocols by wearing the activity tracker for ≥4/7 days of the week for ≥10 hours/day

Exclusion Criteria

I am scheduled for a surgery related to my bones or muscles within 6 months after my first knee replacement.

I use a cane for walking, not a wheelchair.

I have a type of inflammatory arthritis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive usual post-operative care and interventions based on their assigned arm, including wearing activity trackers and receiving coaching and financial incentives

32 weeks

2 in-person visits, regular check-in calls

Follow-up

Participants are monitored for changes in physical activity, pain, functional status, and quality of life

24 months

Multiple assessments at 8, 12, 18, and 24 months post-TKR

Treatment Details

Interventions

• Phone calls to provide information about general well being
• Telephonic Active Coaching (Motivational Interviewing) + Financial Incentives
• Wrist based activity tracker wear

Trial Overview The Knee Arthroplasty Activity Trial tests if post-knee replacement patients can increase physical activity using three methods: basic study activities (surveys and clinic visits), wearing a wrist-based activity tracker, or receiving telephonic coaching plus financial rewards for meeting activity goals alongside the tracker use.

Participant Groups

Group I: Arm3 Experimental Treatment 3 Interventions

Participants in this arm receive usual post-operative care, complete all basic study activities (as described in arm 1), receive wrist-based activity tracker intervention, and receive the TAC(MI)+FI.

Group II: Arm2 Experimental Treatment 2 Interventions

Participants in this arm receive usual post-operative care, complete all basic study activities (as described in arm 1) and receive the wrist-based activity tracker intervention.

Group III: Arm1 Experimental Treatment 1 Intervention

Participants in this arm receive usual post-operative care and complete all basic study activities, which include: attending 2 in-clinic visits at designated time-points, having regular check-in calls with study staff over the intervention period, wearing and returning waist-worn activity trackers at 5 time points over two years, and completing 6 study surveys.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

University of Nebraska

Collaborator

Trials

563

Recruited

1,147,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Northwestern Memorial Hospital

Collaborator

Trials

42

Recruited

15,800+

University of Kansas Medical Center

Collaborator

Trials

527

Recruited

181,000+

University at Buffalo

Collaborator

Trials

139

Recruited

105,000+

University of South Carolina

Collaborator

Trials

233

Recruited

122,000+

Findings from Research

This randomized controlled trial will assess the effectiveness of motivational interviewing (MI) on helping sick-listed individuals return to work, involving participants aged 18-60 who have been on sick leave for over 7 weeks, with outcomes measured over 12 months.

The study will compare MI to usual care and a control group receiving non-MI sessions, aiming to provide insights into the potential benefits of MI for various sick-listed workers, which could inform future healthcare policies and practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing in long-term sickness absence: study protocol of a randomized controlled trial followed by qualitative and economic studies. Aasdahl, L., Foldal, VS., Standal, MI., et al.[2019]

Motivational Interviewing (MI) is an effective approach that can enhance patient engagement and support healthcare reforms aimed at managing chronic diseases, leading to better clinical and financial outcomes.

Deliberate implementation of MI in healthcare settings, rather than passive diffusion, is essential for achieving higher performance levels and improving clinician-patient relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing in primary care. Anstiss, T.[2021]

The study emphasizes the importance of effective communication strategies, such as motivational interviewing, in encouraging patients to follow medical advice and improve their health outcomes.

Using behavioral techniques can enhance patient engagement and adherence to treatment plans, leading to better overall health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing - 'change talk': Improving periodontal outcomes: merging clinical and behavioral science. [2018]

Motivational Interviewing (MI) is an effective, evidence-based method for helping caregivers support individuals in making health behavior changes by addressing their ambivalence.

The success of MI relies on creating a warm, empathetic environment that fosters patient self-efficacy and involves key techniques like expressing empathy and developing discrepancies in patient behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Motivational interviewing: some theoretical aspects and some practical exercises]. Gache, P., Fortini, C., Meynard, A., et al.[2007]

The study found that an automated motivational interviewing technique (TAMI) effectively elicited 'change talk' from participants, with an average of 16 out of 25 responses indicating motivation for change, suggesting its potential efficacy in enhancing motivation.

Participants appreciated the opportunity to reflect on their goals during the automated interview, although they expressed a desire for a more personalized interaction, indicating that while TAMI is motivating, improvements could enhance user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Say it aloud: Measuring change talk and user perceptions in an automated, technology-delivered adaptation of motivational interviewing delivered by video-counsellor. Galvão Gomes da Silva, J., Kavanagh, DJ., May, J., et al.[2020]

Technology-delivered adaptations of motivational interviewing (TAMIs) have shown promise in improving health behaviors, with 88% of the 34 studies reviewed being randomized controlled trials that reported significant positive outcomes.

While many TAMIs included participants from marginalized sociodemographic groups, few were specifically designed for these populations, and none addressed the sociocontextual factors that influence health behaviors, indicating a gap in their design and implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-Delivered Adaptations of Motivational Interviewing for the Prevention and Management of Chronic Diseases: Scoping Review. Pedamallu, H., Ehrhardt, MJ., Maki, J., et al.[2022]

Combining motivational interviewing (MI) with wearable fitness trackers (WFT) improved motivation and psychological needs related to physical activity (PA) in a 12-week study of 40 adults, but did not lead to increased PA participation.

The study found that while MI and WFT enhanced autonomous motivation, individual differences in baseline motivation influenced how effective the WFT was in increasing PA, indicating that motivation levels may affect the outcomes of using fitness trackers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The combined effect of motivational interviewing and wearable fitness trackers on motivation and physical activity in inactive adults: A randomized controlled trial. Nuss, K., Moore, K., Marchant, T., et al.[2023]

A study involving 27 exercise professionals and 10 area coordinators revealed that a 2-day workshop on motivational interviewing (MI) was generally well-received, enhancing awareness of its potential benefits in consultations.

Despite some individual improvements in MI practice, challenges in integrating MI with existing structured activities were noted, indicating a need for ongoing training and support to effectively implement MI in exercise referral schemes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integration of motivational interviewing into practice in the national exercise referral scheme in Wales: a mixed methods study. Moore, GF., Moore, L., Murphy, S.[2019]

In a study involving HIV-infected patients who consumed heavy alcohol, the combination of brief motivational interviewing (MI) and HealthCall (an interactive voice response system) significantly reduced the number of drinks per day compared to a control group, showing the potential for enhanced intervention in this population.

While MI alone also showed some effectiveness, the MI+HealthCall group had the most substantial reduction in drinking, particularly among alcohol-dependent patients, suggesting that this approach could be a valuable tool in HIV primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing heavy drinking in HIV primary care: a randomized trial of brief intervention, with and without technological enhancement. Hasin, DS., Aharonovich, E., O'Leary, A., et al.[2021]

The SystemCHANGE™ + Activity Tracker framework aims to enhance physical activity adherence among kidney transplant recipients by combining personalized strategies with visual feedback from an activity tracker.

This approach empowers patients to take control of their physical activity levels, potentially leading to better long-term health outcomes post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Merging an Activity Tracker with SystemCHANGE™ to Improve Physical Activity in Older Kidney Transplant Recipients. O'Brien, T., Hathaway, D., Russell, CL., et al.[2018]

In a study involving 30 healthy participants, two activity trackers (Garmin Vivofit 3 and Nokia Go) demonstrated good reliability for step counting during normal walking, but their accuracy was poor when participants used crutches.

The Garmin tracker performed slightly better than the Nokia in normal gait, but neither device was valid for measuring steps during crutch-assisted walking, indicating that clinicians should be cautious when using these trackers for rehabilitation after total knee arthroplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activity trackers are not valid for step count registration when walking with crutches. De Ridder, R., De Blaiser, C.[2019]

A study involving 202 participants undergoing total knee replacement (TKR) found that combining telephonic health coaching (THC) with financial incentives (FI) significantly increased physical activity levels, with the THC + FI group achieving an average of 1,808 more steps per day compared to the control group.

The dual intervention not only improved daily step counts but also led to a notable increase in weekly physical activity, demonstrating that financial incentives and health coaching can effectively motivate individuals to enhance their post-surgery activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Financial Incentives and Health Coaching to Improve Physical Activity Following Total Knee Replacement: A Randomized Controlled Trial. Losina, E., Collins, JE., Deshpande, BR., et al.[2020]

The study investigates whether an accelerometer-based activity coaching system can enhance adherence to home-based exercise programs after total knee arthroplasty (TKA), with 110 participants divided into intervention and control groups.

The primary outcome is physical functioning, assessed through the Timed Up and Go test at multiple time points, aiming to determine if the coaching system improves recovery compared to standard home-based exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of the use of a digital activity coaching system in addition to a two-week home-based exercise program in patients after total knee arthroplasty: study protocol for a randomized controlled trial. Harmelink, KEM., Zeegers, AVCM., Tönis, TM., et al.[2018]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Motivational interviewing in long-term sickness absence: study protocol of a randomized controlled trial followed by qualitative and economic studies. [2019]

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

Motivational interviewing in primary care. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Motivational interviewing - 'change talk': Improving periodontal outcomes: merging clinical and behavioral science. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

[Motivational interviewing: some theoretical aspects and some practical exercises]. [2007]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Say it aloud: Measuring change talk and user perceptions in an automated, technology-delivered adaptation of motivational interviewing delivered by video-counsellor. [2020]

6. Canada pubmed.ncbi.nlm.nih.gov

Technology-Delivered Adaptations of Motivational Interviewing for the Prevention and Management of Chronic Diseases: Scoping Review. [2022]

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

The combined effect of motivational interviewing and wearable fitness trackers on motivation and physical activity in inactive adults: A randomized controlled trial. [2023]

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

Integration of motivational interviewing into practice in the national exercise referral scheme in Wales: a mixed methods study. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Reducing heavy drinking in HIV primary care: a randomized trial of brief intervention, with and without technological enhancement. [2021]

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

Merging an Activity Tracker with SystemCHANGE™ to Improve Physical Activity in Older Kidney Transplant Recipients. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Activity trackers are not valid for step count registration when walking with crutches. [2019]

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

Financial Incentives and Health Coaching to Improve Physical Activity Following Total Knee Replacement: A Randomized Controlled Trial. [2020]

13. England pubmed.ncbi.nlm.nih.gov

The effectiveness of the use of a digital activity coaching system in addition to a two-week home-based exercise program in patients after total knee arthroplasty: study protocol for a randomized controlled trial. [2018]

14. England pubmed.ncbi.nlm.nih.gov

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