Clinical trial NCT06734052: Computer-guided Action Planning to Support Physical Activity (CAPPA) for Employees with Chronic Knee Symptoms
Official title: Computer-guided Action Planning to Support Physical Activity (CAPPA) for Employees with Chronic Knee Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis of Knee
Knee Pain Chronic
Keywords: knee symptoms
physical activity
Fitbit
accelerometer
Health coaching
remote coaching
Lead sponsor: Marquette University
Sponsor class: OTHER
Collaborators: name: Northwestern University Feinberg School of Medicine
name: Rush University
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2024-12-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Chronic knee symptoms (CKS) are associated with pain, loss of independence, and increased mortality. Rates of CKS are increasing, fueled by an aging, obese, and sedentary society. Because CKS first presents in working age adults, it is a major cause of work disability and work productivity loss.

Being physically active improves the health of adults who have ongoing (chronic) complaints of knee pain, knee stiffness, or challenges with moving around. Physical activity helps decrease pain, improve stiffness, and improve physical function as it relates to the knee. It also helps people improve their general health. Unfortunately, it is hard for many people to become more physically active. Physical activity can be inconvenient and uncomfortable for many people, and people who join physical activity programs often drop out of them after a short time (3-6 months). However, people are more likely to reach their physical activity goals if they work with a health coach who supports the process.

Health coaching often includes a combination of self-monitoring such as using smart devices to monitor outcomes plus the support of goal-directed behavior. Previous research has found that Fitbit tracking can improve behavior for some people who have CKS but not for others. Whereas we know people can receive benefit from coaching, the exact amount of coaching needed remains unknown. Discussion with employee stakeholders have informed our intervention desire as they have asked for a low resource form of coaching available through the workplace. The potential exists to support employees with CKS using an acceptable, low-resource coaching strategy.

The goal of this program is to test a brief, scalable PA coaching intervention that can assist employees with CKS attain and maintain healthy PA behavior in worksites in the Midwest. CAPPA is a 12-week pilot randomized controlled trial that will 1) use computer-guided action-planning behavioral intervention to support employees in making physical activity action plans for their health, 2) use data transmitted from a personal fitness tracker (Fitbit) to support coach and employee knowledge about PA performance, and 3) Inform on optimal step up times for participants who do not substantially increase PA. The CAPPA system will put PA feedback in a Movement Dashboard to support study participants. The CAPPA intervention will primarily use video chat to attain and sustain healthy PA behavior across worksites at Advocate Aurora Health.

Follow-up measures of PA, pain and physical function are planned at treatment completion and three months following study completion. Specific aims are to: 1) Estimate the efficacy of the intervention to increase objectively measured physical activity, 2) Examine the feasibility, acceptability and sustainability of the CAPPA intervention for the respective workplaces, and 3) Inform the initial step up time for future stepped interventions among participants not substantially increasing their physical activity. This study leverages the combined clinical and technologic expertise of the members of the Physical Activity in Rheumatology Research group at Northwestern University, Northwestern's Arthritis Center Accelerometer unit, Marquette University's Behavior, Engagement and Technology Assessment Lab and Ubiquitous Computing Lab, and Advocate Aurora Health.

This research could have a tremendous impact on improving symptoms and quality of life for those with CKS and early KOA. If treatments are successful at Advocate Aurora Health they may be employed in the services they provide to other organizations.

Eligibility criteria: Inclusion Criteria: Participants must be

1. Age \>/= 18 years
2. Employed at a participating workplace
3. Report pain, aching or stiffness in or around the knee over the past 12 months
4. Report chronic pain, aching or stiffness in or around knee on most days for at least a month over the past 12 months
5. Have access to a device with active internet access to view study dashboard

Exclusion Criteria: Participants will be excluded if they

1. Currently meet CDC PA guidelines (per baseline accelerometer assessment)
2. Have had a joint replacement on the symptomatic side or plan to have one within the next year
3. Have serious medical conditions or impairments that, in the investigators' view, would create safety concerns in the trial such as uncontrolled hypertension (SPB\>160 or diastolic ≥ 100 mm), or symptoms of unstable cardiac or pulmonary disease in the past month ( using the 2021 Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)
4. Are unable to walk 50' with or without an assistive device
5. Plan to relocate from the region within the next year
6. Have limited English literacy
7. Carry a diagnosis of inflammatory arthritis

Primary outcomes:
measure: Proportion of CDC-guideline based physical activity compliance
timeFrame: baseline, 3 month, 6month follow-up
Secondary outcomes:
measure: Fitbit measured physical activity
timeFrame: baseline, week 1, week 2, week 3, week 4.
measure: Tampa Scale of Kinesiophobia
timeFrame: Baseline, 3 months, 6 months
measure: Michigan Body Map
timeFrame: baseline, 3 month, 6 month follow-up
measure: Self-efficacy for physical activity
timeFrame: baseline, 3 month, 6 month follow-up
measure: Numeric Pain Rating Scale
timeFrame: baseline, 3 month, 6 month follow-up
measure: WOMAC pain and physical function sub-scales
timeFrame: baseline, 3 month, and 6 month follow up
measure: PROMIS self reported outcomes
timeFrame: Baseline, 3 month, 6 month follow-up
measure: Performance-based outcomes - Timed up and Go
timeFrame: baseline, 3 month, 6 month follow-up
measure: Performance-based outcomes - 4 meter walk
timeFrame: baseline, 3 month, 6 month follow-up
measure: Performance-based outcomes - 5x sit-stand
timeFrame: baseline, 3 month, 6 month follow-up
measure: Feasibility measure - recruitment rate
timeFrame: 3 month follow-up
measure: Feasibility measures - consent rate
timeFrame: 3 month follow-up
measure: Feasibility measures - drop out rate
timeFrame: 3 month follow-up, 6 month follow-up
measure: Feasibility measures - adherence to protocol
timeFrame: 3 month follow-up
measure: Feasibility measures - personnel retention
timeFrame: 3 month follow-up, 6 month follow-up
measure: Feasibility measures - fidelity
timeFrame: 3 month follow-up
measure: Feasibility measures-qualitative
timeFrame: 3 month follow-up
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Marquette University
state: Wisconsin
Study officials:
affiliation: Marquette University
name: Daniel Pinto, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Rowland W Chang, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: