About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

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

Clinicaltrials.gov identifier NCT03936088

Recruitment Status Recruiting

First Posted May 3, 2019

Last update posted July 23, 2020

Study Description

Brief summary:

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

  • Condition or Disease:Pain
    Osteo Arthritis Knee
  • Intervention/Treatment: Device: Intervention -- "Headspace" mindfulness application
    Device: Control -- "My Water Balance" application
  • Phase: N/A
Detailed Description

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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 360 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Treatment
  • Official Title: Use of a Self-Guided Mindfulness Mobile Application to Improve Pain Outcomes in Individuals With Knee Osteoarthritis
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: February 2022
  • Estimated Study Completion Date: February 2022
Arms and interventions
Arm Intervention/treatment
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.
Outcome Measures
  • Primary Outcome Measures: 1. Post-intervention change in Knee injury and Osteoarthritis Outcome (KOOS) pain subscale [ Time Frame: 0,12, 26, 52, and 104 weeks ]
    The KOOS is a validated knee-specific patient-reported outcome survey designed to assess an individual's perception of their knee pain and associated disability. It has 42 items in 5 separately scored subscales; Pain, other Symptoms, ADL function, Sport and Recreation function, and knee-related Quality of Life (QOL). All items are scored 0-4; for each subscale the scores are transformed to a 0-100 scale (0 representing extreme knee problems and 100 representing no knee problems).
  • Secondary Outcome Measures: 1. Change in KOOS subscale scores [ Time Frame: 0,12, 26, 52, and 104 weeks ]
    The KOOS is a validated knee-specific patient-reported outcome survey designed to assess an individual's perception of their knee pain and associated disability. It has 42 items in 5 separately scored subscales; Pain, other Symptoms, ADL function, Sport and Recreation function, and knee-related Quality of Life (QOL). All items are scored 0-4; for each subscale the scores are transformed to a 0-100 scale (0 representing extreme knee problems and 100 representing no knee problems).
  • 2. Change in Five Facet Mindfulness Questionnaire (FFMQ) outcomes [ Time Frame: 0,12, 26, 52, and 104 weeks ]
    The FFMQ-15 is designed to provide a quantitative evaluation of mindfulness. It is based on five independently developed mindfulness questionnaires.The questionnaire has 39 items. The five facets are: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
  • 3. Change in Short Form Health Survey (SF-12) self-reported mental and physical health self-assessments [ Time Frame: 0,12, 26, 52, and 104 weeks ]
    The SF-12 is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 74 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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.

Contacts and Locations
Contacts

Contact: Jill M Clark, MBA 7026533298 Jill.M.Clark15.ctr@mail.mil

Contact: Amanda J Crawford, BA 7026532113 amanda.j.crawford.ctr@mail.mil

Locations

United States, Illinois
375th Medical Group
Scott Air Force Base

Sponsors and Collaborators

jilliansylvester

Mike O'Callaghan Military Hospital

375th Medical Group, Scott Air Force Base

Travis AFB 60th Med Group

Investigators

Principal Investigator: Jillian E Sylvester, MD US Air Force

More Information