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Our mission is to provide healthcare professionals with unbiased clinical research information, easily.
Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03936088
Recruitment Status Recruiting
First Posted May 3, 2019
Last update posted July 23, 2020
This study will investigate if mindfulness training via a smartphone mobile app is effective in improving OA-related knee pain.
The investigator's primary aim in this study is to determine if regular use of a mindfulness application improves pain outcomes in adults with knee osteoarthritis. The investigator's secondary aim is to determine if self-reported Healthcare-Related Quality of Life (HRQoL) scores predict response to mindfulness treatment in OA. The investigators hypothesize that the use of an mHealth intervention for mindfulness training may be an effective adjunct treatment of chronic knee osteoarthritis pain; specifically, that regular use of a mindfulness application will result in a statistically significant reduction in pain outcomes and improvement in physical function as determined by the KOOS scoring system. The investigators also hypothesize that those with lower baseline self-reported HRQoL scores are more likely to see a greater improvement in their pain and function with use of a mindfulness application than those with higher baseline scores.
|Experimental: Intervention with Mindfulness App (Headspace)
Patient education regarding osteoarthritis, its natural history, and common treatments plus the mindfulness (intervention) app.
Device: Intervention -- "Headspace" mindfulness application
Patients will be provided with a pre-paid 12-week subscription to the mindfulness application, and provided an in-person demonstration on how to use it, and the subscription license code will be recorded for the purposes of tracking use after the conclusion of the study. The intervention group will be asked to use the mindfulness app 10 minutes per day/5 days per week. To standardize Pack usage across all participants, users will be asked to complete the Headspace Essentials", "Pain Management", and "Physical Health" Session Packs.
|Active Comparator: Control with Water App (My Water Balance)
Patient education regarding osteoarthritis, its natural history, and common treatments plus the My Water Balance (control) app and provided an in-person demonstration on how to use it.
Device: Control -- "My Water Balance" application
My Water Balance calculates an individual's recommended daily water requirements and assists users in tracking their daily fluid intake. The control group will be asked to log their water intake for the duration of the study, with requested use of 5 days per week to create an equal control. This application is free to download and use. There are options for in-app purchases and application upgrades, though users will be advised against doing so. Information logged in the application may be stored on a third party server; however, no application data will be extracted by the study team. Application use will be reported via weekly surveys, alone.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
**Patients must be able to get care at Nellis, Scott, or Travis Air Force Base (a military
installation) in order to participate in this study**
- Male and female Active Duty members and DoD beneficiaries ages 18-74 years
- Meet criteria for symptomatic knee osteoarthritis according to the American College of
Rheumatology (pain on more than half of the days of the past month during at least one
of the following activities: walking, ascending or descending stairs, standing
upright, or lying in bed at night)
- Demonstrate radiographic evidence of OA, with Kellgren and Lawrence (KL) Grade ≥1 as
determined by Lead Site Investigator at each study location
- Must have access to a smartphone with enough memory to download the app My Water
Balance or the Mindfulness app
- Intra-articular corticosteroid injection in the 3 months prior to participation in the
- Intra-articular hyaluronic acid/PRP injection in the 6 months prior to participation
in the study
- Medical condition contraindicating moderate aerobic exercise as determined by their
- History of knee surgery in the past 6 months or previous knee arthroplasty
- Inflammatory joint disease.
- Current Practice of Mindfulness
- Currently pregnant or planning pregnancy over the study period
- Enrollment in other clinical research study during the study period
- Inability to comply with treatment protocol, including participation in the Rx3 Home
Contact: Jill M Clark, MBA 7026533298 Jill.M.Clark15.firstname.lastname@example.org
Contact: Amanda J Crawford, BA 7026532113 email@example.com
United States, Illinois
375th Medical Group
Scott Air Force Base
Mike O'Callaghan Military Hospital
375th Medical Group, Scott Air Force Base
Travis AFB 60th Med Group
Principal Investigator: Jillian E Sylvester, MD US Air Force
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