Computer-guided Action Planning to Support Physical Activity (CAPPA) for Employees With Chronic Knee Symptoms

NCT06734052 | Completed

• 2 other identifiers: AR0810071R21AR081007-01A1
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis of Knee; Knee Pain Chronic

Keywords

knee symptoms; physical activity; Fitbit; accelerometer; Health coaching; remote coaching

Outcome Measures

Primary Outcomes (1)

• Proportion of CDC-guideline based physical activity compliance

  Proportion of people per treatment arm meeting CDC guidelines for aerobic physical activity. How many participants per group have achieved 150 minutes of weekly moderate-to-vigorous physical activity.

  baseline, 3 month, 6month follow-up

Secondary Outcomes (17)

• Fitbit measured physical activity

  baseline, week 1, week 2, week 3, week 4.

• Tampa Scale of Kinesiophobia

  Baseline, 3 months, 6 months

• Michigan Body Map

  baseline, 3 month, 6 month follow-up

• Self-efficacy for physical activity

  baseline, 3 month, 6 month follow-up

• Numeric Pain Rating Scale

  baseline, 3 month, 6 month follow-up

Study Arms (2)

Computer-guided Action Planning to support Physical Activity (CAPPA)

EXPERIMENTAL

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.

Behavioral: CAPPA

Health education

ACTIVE COMPARATOR

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.

Behavioral: Health education

Interventions

CAPPA BEHAVIORAL

See CAPPA arm description.

Computer-guided Action Planning to support Physical Activity (CAPPA)

Health education BEHAVIORAL

See health education arm description

Health education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Currently meet CDC PA guidelines (per baseline accelerometer assessment)
• Have had a joint replacement on the symptomatic side or plan to have one within the next year
• 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+)
• Are unable to walk 50' with or without an assistive device
• Plan to relocate from the region within the next year
• Have limited English literacy
• Carry a diagnosis of inflammatory arthritis

Sponsors & Collaborators

• Marquette University: lead
• Northwestern University Feinberg School of Medicine: collaborator
• Rush University: collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Marquette University

Milwaukee, Wisconsin, 53233, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Study Officials

• Daniel Pinto, PhD

  Marquette University

  PRINCIPAL INVESTIGATOR

• Rowland W Chang, MD MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 16, 2024
• First Posted: December 16, 2024
• Study Start: August 12, 2024
• Primary Completion: February 2, 2026
• Study Completion: February 3, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD will be available 1 year after NIH final report submission.
• Access Criteria: IPD can be accessed by those who submit a proposal to the CAPPA leadership team describing planned analyses using a cloud-based online submission form. No formal data sharing agreement need be signed. To facilitate interpretation of the data, data dictionaries and protocols will be shared and associated with the relevant datasets via readme.txt files for the associated data. Data files will be archived using a SAS-based project-specific database with detailed documentation of any editing and data review adjudications while keeping original data files intact. Archived data files used to derive data analysis and original data files of non-identifiable, outcomes-related IPD will be shared.

Locations

US (1)