Clincosm LogoSign in Get a demo

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

Sponsor
jilliansylvester (U.S. Fed)
Overall Status
Active, not recruiting
CT.gov ID
NCT03936088
Collaborator
Mike O'Callaghan Military Hospital (U.S. Fed), 375th Medical Group, Scott Air Force Base (U.S. Fed), Travis AFB 60th Med Group (Other)
75
Enrollment
1
Location
2
Arms
43
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase
  • Device: Intervention -- "Headspace" mindfulness application
  • Device: Control -- "My Water Balance" application
 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
Actual Enrollment :
75 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 2, 2019
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 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 [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 [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 [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 [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

Criteria

Ages Eligible for Study:
18 Years to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Locations

Site City State Country Postal Code
1 375th Medical Group Scott Air Force Base Illinois United States 62225

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

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
jilliansylvester, Principal Investigator, 375th Medical Group, Scott Air Force Base
ClinicalTrials.gov Identifier:
NCT03936088
Other Study ID Numbers:
  • FWH20190033H
First Posted:
May 3, 2019
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee

Study Results

No Results Posted as of Apr 12, 2022