CAPPA for Chronic Knee Pain

(CAPPA Trial)

Overseen By Daniel Pinto, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Marquette University

Disqualifiers: Joint replacement, Uncontrolled hypertension, Arthritis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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 physical activity in employees with chronic knee symptoms who work for Advocate Aurora Health. The main questions it aims to answer are: * Will a greater proportion of people in the health coaching intervention increase physical activity to at least 150 minutes of moderate-to-vigorous physical activity per week than a group of people with an attention-control intervention (Fitbit+health education coaching)? * Can we predict who will not increase physical activity levels to at least 150 minutes of moderate-to-vigorous physical activity per week by the end of the study (3 and 6 months) based upon Fitbit data captured over the first four weeks? Researchers will compare a health education coaching intervention + Fitbit to see if providing a Fitbit + attention control will increase physical activity to at least 150 minutes of moderate-to-vigorous physical activity per week among members of the attention-control group. Participants will engage in * Online study orientation and question and answer session * Three assessment sessions (baseline, 3 months, 6 months) * A 12 week intervention with no less than four (4) and no more than twelve (12) health coaching sessions. Physical activity health coaching will make action plans for health coaching. Health education coaching will focus on educating participants on non-physical activity factors related to a comprehensive management of chronic knee symptoms, such as managing fatigue, sleep hygiene, mindfulness, etc.

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 data supports the effectiveness of the treatment CAPPA for chronic knee pain?

Research shows that improving patient enablement can enhance the quality of life for those with chronic knee pain, suggesting that treatments like CAPPA, which support physical activity, may be beneficial. Additionally, patient education and exercise therapy have been shown to improve knee pain and quality of life, indicating that similar approaches could be effective. ^{1 2 3 4 5}

How does the CAPPA treatment for chronic knee pain differ from other treatments?

CAPPA is unique because it uses computer-guided action planning to help patients increase their physical activity, focusing on self-management and tailored exercise plans. This approach is different from traditional treatments that may not emphasize personalized activity planning and behavior change strategies. ^{6 7 8 9 10}

Research Team

Daniel Pinto, PhD

Principal Investigator

Marquette University

Rowland W Chang, MD MPH

Principal Investigator

Northwestern University

Eligibility Criteria

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

1. Age \>/= 18 years

2. Employed at a participating workplace

Trial Timeline

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)

Treatment Details

Interventions

• CAPPA (Behavioural Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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 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 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]

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]

References

1. United States 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. [2021]

2. England 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. [2023]

3. England 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. [2021]

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

The contribution of selected non-articular conditions to knee pain severity and associated disability in older adults. [2021]

5. Canada pubmed.ncbi.nlm.nih.gov

The natural history of disability and its determinants in adults with lower limb musculoskeletal pain. [2009]

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

Assessment of physical activity in daily life in patients with musculoskeletal pain. [2022]

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

Physical activity coaching of patients with rheumatoid arthritis in everyday practice: a long-term follow-up. [2022]

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

Clinical utility of a mHealth assisted intervention for activity modulation in chronic pain: The pilot implementation of pain ROADMAP. [2023]

9. United States 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. [2019]

10. Canada 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. [2023]