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Use of a Self-Guided Mindfulness Mobile Application to Improve Pain Outcomes in Individuals With Knee Osteoarthritis

Study Purpose

This study will investigate if mindfulness training via a smartphone mobile app is effective in improving OA-related knee pain.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 74 Years
Gender All
More Inclusion & Exclusion Criteria

**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**

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - Intra-articular corticosteroid injection in the 3 months prior to participation in the study.
  • - 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 physician.
  • - History of knee surgery in the past 6 months or previous knee arthroplasty.
  • - Inflammatory joint disease.
  • - Current Practice of Mindfulness.
  • - Non-English-speaking.
  • - 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 Exercise Program.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03936088
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 jilliansylvester
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jillian E Sylvester, MD
Principal Investigator Affiliation US Air Force
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 U.S. Fed, Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Osteo Arthritis Knee, Pain
Additional Details

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.

Arms & Interventions

Arms

Experimental: Intervention with Mindfulness App (Headspace)

Patient education regarding osteoarthritis, its natural history, and common treatments plus the mindfulness (intervention) app.

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.

Interventions

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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

375th Medical Group, Scott Air Force Base, Illinois

Status

Recruiting

Address

375th Medical Group

Scott Air Force Base, Illinois, 62225

Site Contact

Jill M Clark, MBA/HCM

[email protected]

702-653-3298

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