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Not recruiting

CAPPA

Sponsor:

Marquette University

Code:

NCT06734052

Conditions

Osteoarthritis of Knee

Knee Pain Chronic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CAPPA

Health education

Study Details

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

Study ID

NCT06734052

Start date

Aug 12, 2024

Status verified date

Sep, 2024

Completion date

Sep 30, 2025

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

active comparator: Health education

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.

Interventions

CAPPA

See CAPPA arm description.

Health education

See health education arm description

Primary outcome measure

  • Proportion of CDC-guideline based physical activity compliance [ Time Frame: baseline, 3 month, 6month follow-up ]

Central Contacts and Locations

Central contacts

Daniel Pinto, PhD

414-288-4495d.pinto@marquette.edu

Rowland W Chang, MD, MPH

312-503-2952

Locations

Marquette University

Recruiting

Milwaukee, Wisconsin, United States, 53233

Contacts

Daniel Pinto, PhD

414-288-4495d.pinto@marquette.edu

Sheik I Ahamed, PhD

sheikh.ahamed@marquette.edu

More Information

Sponsor

Marquette University

Last update posted

Dec 16, 2024

Last verified

Sep, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by Marquette University on 2024-12-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.