NCT07896473|Not Yet Recruiting
Study Comparing Osteoarthritis Programs
SCOAP
Evaluation of the Integrated Mindfulness Walking (I'M Walking) Program for Older Primary Care Patients With Knee Osteoarthritis
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SCOAP
Evaluation of the Integrated Mindfulness Walking (I'M Walking) Program for Older Primary Care Patients With Knee Osteoarthritis
Sponsor study identifier
Secondary identifiers
NIH
interventional
200
1 country
1
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this clinical trial is to learn if a behavioral program called I'M Walking will help with pain in middle-aged and older adults.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 20, 2026
Actual (reported)October 27, 2026
Actual (reported)November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Difference between groups in pain interference as measured by PROMIS Pain Interference (PI) Short Form 8a at week 24
Pain interference will be measured by the 8-item PROMIS Short Form 8a Pain Interference measure. This measure assesses how much pain disrupts a person's daily activities and enjoyment of life over the past 7 days. Each question is a 5-point likert scale from 1 (Not at all) to 5 (Very much) with a higher score indicating more pain interference. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 40.7 to 77.0. Lower T-scores represent better outcomes.
Week 24
Difference between groups in pain intensity (Brief Pain Inventory Pain Intensity Subscale) at Week 24
Week 24
Difference between groups in physical function (PROMIS Physical Function Short Form 6b) at week 24
Week 24
Difference between groups in depressive symptoms (Patient Health Questionnaire; PHQ-8) at week 24
Week 24
Difference between groups in anxiety symptoms (Generalized Anxiety Disorder; GAD-7) at week 24
Week 24
Difference between groups in treatment satisfaction (Patient Global Impression of Change; PGIC) at week 24
Week 24
Participants in the I'M Walking arm will gain access to a website with 8 modules of a mindfulness-based intervention (MBI) which will include videos and a written manual with worksheets for practice and additional resources.
Participants in the Walk With Ease arm will be directed to use the publicly available WWE self-directed online program.
Participants in the I'M Walking arm will gain access to a website with 8 modules of a mindfulness-based intervention (MBI) which will include videos and a written manual with worksheets for practice and additional resources. Modules include information regarding integrating mindfulness into walking exercises, meditation practices, and mind-body awareness. The MBI is intended to reduce pain interference and encourage increased physical activity. The study team anticipates that each module will take approximately 45 minutes to complete, for a total of 360 minutes. A physical therapist will monitor patients' steps on the ExerciseRx app dashboard and will coach patients through completion of the 8 MBI modules. Through 4, 45-minute phone calls or videoconferences, the physical therapist will address patient concerns to implementing the MBI skills into their daily life and counsel them to increase physical activity through walking.
University of Washington Medical Center
Seattle, Washington, 98195, United States
Cary Reid, MD, PhD
Weill Medical College of Cornell University
First Submitted
October 20, 2026
First Posted
October 27, 2026
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
June 30, 2028
EstimatedParticipants in the Walk With Ease arm will be directed to use the publicly available WWE self-directed online program. Study staff will assist participants in making an account on the Osteoarthritis Action Alliance website where they can access the WWE book, videos, and interactive activity tracking modules. They will be instructed to complete 1 chapter per week. The WWE program is widely disseminated and available for older adults with osteoarthritis. A trained health educator will meet with each patient for 4, 30-45-minute phone calls and/or videoconferences to discuss the WWE program, answer questions, and provide arthritis education regarding pain management, exercise, and sleep.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Source: ClinicalTrials.gov.
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