CAPPA for Chronic Knee Pain

(CAPPA Trial)

Overseen By Daniel Pinto, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Marquette University

Disqualifiers: Joint replacement, Uncontrolled hypertension, Arthritis, others

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

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a health coaching program paired with a fitness tracker, such as a Fitbit, can help employees with ongoing knee pain become more active. It aims to determine if participants can achieve at least 150 minutes of moderate exercise per week and identify those who might struggle to meet this goal. The study compares two groups: one receives personalized action plans with motivational coaching (Computer-guided Action Planning to Support Physical Activity, or CAPPA), while the other receives general health education. This trial is ideal for employees with chronic knee pain who have not yet met exercise guidelines and have internet access. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve health outcomes for individuals with chronic knee pain.

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 is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this health coaching intervention is safe for increasing physical activity in employees with chronic knee symptoms?

Research shows that physical activity can improve the health of adults with chronic knee pain. The CAPPA program, which stands for Computer-guided Action Planning to support Physical Activity, uses a computer to help people plan and maintain increased activity levels.

Specific safety data for CAPPA itself is currently unavailable. However, the program includes health coaching and uses a Fitbit to track activity, making it generally considered safe. Health coaching programs are typically easy to manage and do not involve drugs or medical procedures.

In this program, CAPPA helps create personalized action plans with a coach, providing support and encouragement. Participants use a Fitbit to monitor their activity, and this combination has been shown to help people safely increase their physical activity.

Since this trial does not test a new drug or medical device, it focuses on behavior change, which usually presents fewer safety concerns. Overall, the CAPPA approach encourages healthy lifestyle changes, which are safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CAPPA approach for chronic knee pain because it offers a personalized, tech-driven method to boost physical activity. Unlike traditional treatments that might focus on medication or general exercise advice, CAPPA uses computer-guided action planning and motivational interviewing to create custom plans tailored to each person's needs. The integration of Fitbit data through a specialized Movement Dashboard helps coaches monitor and discuss daily activity levels with participants, providing a dynamic and interactive way to manage pain through increased movement. This approach emphasizes personal empowerment and self-management, which could lead to more sustainable lifestyle changes for those suffering from chronic knee pain.

What evidence suggests that this trial's treatments could be effective for increasing physical activity in employees with chronic knee pain?

Research shows that physical activity can alleviate long-term knee pain. Studies have found that tools like Fitbits and health coaches encourage increased movement. In this trial, participants in the CAPPA arm will receive Computer-guided Action Planning to support Physical Activity, which helps create personalized plans to encourage movement. This method employs motivational interviewing, a conversational technique that helps individuals discover their own reasons for change. Early results suggest this approach might increase activity levels, potentially reducing knee pain and enhancing overall quality of life. ^{1 5 6 7 8}

Who Is on the Research Team?

Daniel Pinto, PhD

Principal Investigator

Marquette University

Rowland W Chang, MD MPH

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for Advocate Aurora Health employees with chronic knee symptoms, such as pain or arthritis. Participants should be willing to wear a Fitbit and attend online sessions plus health coaching. Those who can't commit to the study duration or have conditions that prevent them from following the intervention may not qualify.

Inclusion Criteria

Inclusion Criteria: Participants must be

2. Employed at a participating workplace

3. Report pain, aching or stiffness in or around the knee over the past 12 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Orientation

Online study orientation and question and answer session

1 week

1 visit (virtual)

Treatment

Participants engage in a 12-week intervention with health coaching sessions and use of Fitbit to increase physical activity

12 weeks

4-12 visits (virtual)

Follow-up

Participants are monitored for physical activity, pain, and physical function after treatment completion

3 months

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• CAPPA

Trial Overview The trial tests if a brief action planning health coaching intervention combined with using a Fitbit increases physical activity more than just receiving health education and a Fitbit. It measures whether participants reach at least 150 minutes of moderate-to-vigorous exercise weekly after 3 and 6 months.

How Is the Trial Designed?

Group I: Computer-guided Action Planning to support Physical Activity (CAPPA) Experimental Treatment 1 Intervention

Participants in the CAPPA Arm receive a Fitbit and health coaching using Computer-guided Action planning. Coaches will utilize the coaching software within www.myactionplans.com to guide the coaching interaction and support physical activity plan development. The emphasis is this arm is to create plans that are person-centered and driven by the participant. The action planning process is grounded in the conversational style of motivational interviewing and follows Brief Action Planning as a self-management support style. Coaches in the CAPPA arm will also have access to a custom Movement Dashboard which that uses Fitbit data to plot daily physical activity. The dashboard is coach-facing and is used to support coach dialogue about physical activity. There is scheduling flexibility: 4-12 visits over the 12-week period. Participants are strongly encouraged not to have a gap longer than three weeks between visits.

Group II: Health education Active Control 1 Intervention

Participants in Arm 2 receive a Fitbit and health education delivered by a coach. Health education selects topics from the chronic disease self-management program that address common features of living with a chronic condition. Arm 2 avoids making specific plans and avoids discussion of physical activity. The emphasis in this arm is in providing education. There is scheduling flexibility, 4-12 visits over the 12-week period. Participants are strongly encouraged not to have a gap longer than three weeks between visits to keep the content fresh.

Who Is Running the Clinical Trial?

Marquette University

Lead Sponsor

Trials

68

Recruited

202,000+

Northwestern University Feinberg School of Medicine

Collaborator

Trials

42

Recruited

15,500+

Rush University

Collaborator

Trials

46

Recruited

3,294,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Published Research Related to This Trial

In a study of 1306 Chinese patients with chronic back and knee pain, higher levels of patient enablement were found to significantly reduce the negative impact of pain on health-related quality of life (HRQoL).

The analysis showed that patients with low enablement experienced a stronger negative relationship between pain and HRQoL compared to those with high enablement, indicating that improving patient enablement can enhance overall well-being despite chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient enablement and health-related quality of life for patients with chronic back and knee pain: a cross-sectional study in primary care. Ng, APP., Cheng, JKY., Lam, JSM., et al.[2023]

In a study of 1072 individuals with chronic hip and knee pain, factors such as older age, lower socioeconomic status, multiple comorbidities, and severe pain were linked to a higher risk of developing disability over an 8-year period.

Conversely, similar factors were associated with improvement in disability, indicating that addressing these determinants could help prevent long-term disability in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The natural history of disability and its determinants in adults with lower limb musculoskeletal pain. Ayis, S., Dieppe, P.[2009]

A one-year coaching program aimed at increasing physical activity in 228 patients with early rheumatoid arthritis did not lead to significant long-term improvements in perceived general health or other health outcomes after two years.

While the intervention group showed different patterns of physical activity behavior compared to the control group, the lack of sustained behavioral elements may have contributed to the absence of lasting benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity coaching of patients with rheumatoid arthritis in everyday practice: a long-term follow-up. Sjöquist, ES., Brodin, N., Lampa, J., et al.[2022]

The intervention mapping framework was effectively used to design a program that enhances adherence to prescribed exercise for individuals with persistent musculoskeletal pain, focusing on self-management and tailored exercise instructions.

The program, which includes virtual motivational interviewing and an app-based exercise platform, was found to be feasible and acceptable in a proof-of-concept study, indicating its potential for supporting exercise adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Intervention Mapping in the Systematic Development of a Behaviour Change Intervention to Enhance Exercise Adherence among People with Persistent Musculoskeletal Pain. Meade, LB., Bearne, LM., Godfrey, EL.[2023]

In a study of 745 older adults with knee pain, 36.6% had at least one non-articular condition (NAC), such as widespread pain or low back pain, which significantly increased their pain severity and functional limitations compared to those without NACs.

The presence of NACs contributed to higher pain and functional limitation scores, indicating that these conditions should be considered as important factors alongside osteoarthritis when assessing knee pain in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The contribution of selected non-articular conditions to knee pain severity and associated disability in older adults. Wood, LR., Peat, G., Thomas, E., et al.[2021]

The study identified 34 different instruments for assessing physical activity in patients with musculoskeletal pain, including questionnaires, diaries, and movement registration tools, highlighting the need for standardized measurement methods.

Movement registration tools are preferred for objectively measuring physical activity levels, but only 10 of the 34 instruments reviewed provided adequate information on their psychometric properties, indicating a gap in reliable assessment methods for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of physical activity in daily life in patients with musculoskeletal pain. Verbunt, JA., Huijnen, IP., Köke, A.[2022]

A systematic review of 8 randomized controlled trials, including 116 participants, found that physical activity interventions using electronic feedback did not significantly reduce pain or disability compared to minimal interventions in patients with chronic musculoskeletal pain.

The overall quality of the evidence was rated as low, suggesting that clinicians should be cautious in using these electronic feedback interventions for managing chronic musculoskeletal pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity-Based Interventions Using Electronic Feedback May Be Ineffective in Reducing Pain and Disability in Patients With Chronic Musculoskeletal Pain: A Systematic Review With Meta-Analysis. Oliveira, CB., Franco, MR., Maher, CG., et al.[2019]

A new core set for assessing knee dysfunction was developed from a study involving 388 participants, identifying 24 key categories that encompass body functions, structures, activities, participation, and environmental factors.

This comprehensive assessment tool aims to improve the evaluation of knee dysfunction by considering various aspects of functionality that are often overlooked in traditional assessment methods, although further validation is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Core Set for Knee Dysfunction Based on the International Classification of Functioning, Disability and Health: A Cross-sectional Study. Fréz, AR., Alouche, SR., Binda, AC., et al.[2021]

The Pain ROADMAP mobile health platform was well-accepted by 20 adults with chronic pain, showing good adherence to monitoring and follow-up, which suggests its feasibility for supporting activity modulation.

Participants experienced clinically meaningful improvements, including reduced pain variation, decreased opioid use, and increased productivity, indicating the potential efficacy of this tailored intervention without any adverse outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical utility of a mHealth assisted intervention for activity modulation in chronic pain: The pilot implementation of pain ROADMAP. Andrews, NE., Ireland, D., Deen, M., et al.[2023]

A study involving 6,767 patients with knee osteoarthritis aimed to create models predicting individual changes in pain intensity, quality of life, and walking speed after exercise therapy, but found that these models did not provide more precise predictions than average outcomes.

The models showed limited predictive power, with R2 values of 0.34 for pain intensity and much lower for quality of life and walking speed, suggesting that average improvement values are more reliable for informing patients about expected outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized predictions of changes in knee pain, quality of life and walking speed following patient education and exercise therapy in patients with knee osteoarthritis - a prognostic model study. Baumbach, L., List, M., Grønne, DT., et al.[2021]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10756512

Computer-guided Action Planning to Support Physical ... CAPPA is assessing whether an action planning intervention supporting physical activity can increase and sustain physical activity in employees with chronic ...

2. trials.arthritis.org trials.arthritis.org/trials/NCT06734052

Computer-guided Action Planning to Support Physical Activity ... The goal of this clinical trial is to learn if a brief health coaching intervention based on an approach known as brief action planning + Fitbit can increase ...

3. allclinicaltrials.com allclinicaltrials.com/study/NCT06734052

CAPPA - Computer-guided Action Planning to Support ... The goal of this clinical trial is to learn if a brief health coaching intervention based on an approach known as brief action planning + Fitbit can ...

4. withpower.com withpower.com/trial/cappa-for-chronic-knee-pain-97696

CAPPA for Chronic Knee Pain A study involving 6,767 patients with knee osteoarthritis aimed to create models predicting individual changes in pain intensity, quality of life, and walking ...

5. mentalhealth.networkofcare.org mentalhealth.networkofcare.org/Lake/CommunityResources/ClinicalTrials/Detail/NCT06734052?keyword=%22Accelerometer%22

Computer-guided Action Planning to Support Physical ... ~Being physically active improves the health of adults who have ongoing (chronic) complaints of knee pain, knee stiffness, or challenges with moving around.

6. trialx.com trialx.com/clinical-trials/listings/316578/computer-guided-action-planning-to-support-physical-activity-cappa-for-employees-with-chronic-knee-symptoms/

Computer-guided Action Planning to Support Physical Activity ... Being physically active improves the health of adults who have ongoing (chronic) complaints of knee pain, knee stiffness, or challenges with moving around.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06734052/computer-guided-action-planning-to-support-physical-activity-cappa-for-employees-with-chronic-knee-symptoms

Computer-guided Action Planning to Support Physical Activity ... Being physically active improves the health of adults who have ongoing (chronic) complaints of knee pain, knee stiffness, or challenges with moving around.

8. marquette.edu marquette.edu/news-center/2023/physical-therapy-professor-receives-nih-grant-to-develop-physical-activity-intervention-for-people-with-chronic-knee-pain.php

Marquette University physical therapy professor receives ... The outcomes of this plan will produce physical, mental, and financial benefits to so many dealing with chronic knee pain.” Dr. Sheikh Iqbal ...