Computer-guided Action Planning to Support Physical Activity (CAPPA) for Employees With Chronic K… (NCT06734052) | Clinical Trial Compass
CompletedNot Applicable
Computer-guided Action Planning to Support Physical Activity (CAPPA) for Employees With Chronic Knee Symptoms
United States39 participantsStarted 2024-08-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Currently meet CDC PA guidelines (per baseline accelerometer assessment)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of CDC-guideline based physical activity compliance
. 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