Smartphone Mindfulness Meditation for Patients With Rheumatic Diseases

April 22, 2021 updated by: Johns Hopkins University

Smartphone App Mindfulness-Based Intervention for Patients With Rheumatic Diseases

This study will assess the effect of a mindfulness meditation program administered via a smartphone application on health-related quality of life for patients with rheumatic disease.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

After obtaining written consent, participants will be asked to download and use the Calm meditation smartphone application everyday for a 30-day period. Participant demographics and clinical information will be collected at baseline. Participants will additionally be asked to complete questionnaires concerning health-related quality of life (HRQoL) as well as mental health, stress, and self-efficacy at baseline and at the end of the 30 day study period. A brief check-in via telephone will be conducted on day 15.

Participants using the calm app will be compared to participants receiving usual care who will be asked to complete identical sets of questionnaires. The participant may choose whether they join the Calm application vs usual care (questionnaires only) group on a voluntary basis; there is no pre-assignment. The Calm application is a publicly available program that is available to any patient independent of this study.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Established patients of the Johns Hopkins (JH) Rheumatology Division will be eligible for participation.

  • Participants must have one of the following JH rheumatologist-diagnosed and/or confirmed diseases: inflammatory arthritis, scleroderma, myositis, Sjogren's syndrome, systemic lupus erythematosus, and vasculitis.
  • Participants must be at least 18 years of age to participate; there is no upper-bound age limit
  • Participants must have access to a smartphone or computer to access the Calm app (or webpage) as well as Redcap (which requires an email address) to access the questionnaires

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Participant groups will include enrolled patients with rheumatic disease who use the smartphone mindfulness meditation application for 30 days.
Behavioral: Calm- Mindfulness Meditation smartphone application
Participants will be asked to register and download the Calm application on participants' phones or home computer. Daily use for a minimum of 5 minutes will be suggested and will be recorded at study end.
No Intervention: Control group
Usual care participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants recruited
Time Frame: 2 years
The investigators' goal is to recruit 264 participants. The investigators will report the number of participants recruited which will be a measure of Percentage of target enrollment achieved.
2 years
Total number of minutes per participant
Time Frame: 30 days
The program consists of a total of 150 minutes. The investigators will report the total number of minutes per participant as a measure of adherence to program.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anxiety as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) Global-29 profile
Time Frame: Baseline, 30 days
The PROMIS global-29 measure is reported as a profile. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured. The anxiety T-score (subscale of PROMIS being used here) ranges from 40-81.
Baseline, 30 days
Change in Depression as assessed by the PROMIS Global-29 profile
Time Frame: Baseline, 30 days
The PROMIS global-29 measure is reported as a profile. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured. The depression T-score (subscale of PROMIS being used here) ranges from 41-79.
Baseline, 30 days
Change in Fatigue as assessed by the PROMIS Global-29 profile
Time Frame: Baseline, 30 days
The PROMIS global-29 measure is reported as a profile. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured. The fatigue T-score (subscale of PROMIS being used here) ranges from 33-75.
Baseline, 30 days
Change in Physical Function as assessed by the PROMIS Global-29 profile
Time Frame: Baseline, 30 days
The PROMIS global-29 measure is reported as a profile. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured. The physical function T-score (subscale of PROMIS being used here) ranges from 22-56.
Baseline, 30 days
Change in Social participation as assessed by the PROMIS Global-29 profile
Time Frame: Baseline, 30 days
The PROMIS global-29 measure is reported as a profile. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured. The social participation T-score (subscale of PROMIS being used here) ranges from 29-64.
Baseline, 30 days
Change in Pain interference as assessed by the PROMIS Global-29 profile
Time Frame: Baseline, 30 days
The PROMIS global-29 measure is reported as a profile. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured. The pain interference T-score (subscale of PROMIS being used here) ranges from 41-75.
Baseline, 30 days
Change in Sleep disturbance as assessed by the PROMIS Global-29 profile
Time Frame: Baseline, 30 days
The PROMIS global-29 measure is reported as a profile. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured. The sleep disturbance T-score (subscale of PROMIS being used here) ranges from 32-73.
Baseline, 30 days
Change in Anxiety as assessed by the PROMIS anxiety computer adaptive testing (CAT)
Time Frame: Baseline, 30 days
The PROMIS anxiety CAT has a T-score range of 40 to 81. For PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured.
Baseline, 30 days
Change in Depression as assessed by the PROMIS depression CAT
Time Frame: Baseline, 30 days
The PROMIS depression CAT has a T-score range of 38 to 81. For PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured.
Baseline, 30 days
Change in Self-Efficacy for managing emotions as assessed by the PROMIS self-efficacy for managing emotions short form (8a)
Time Frame: Baseline, 30 days
The PROMIS self-efficacy for managing emotions form has a T-score range of 22 to 64. For PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured.
Baseline, 30 days
Change in Self-Efficacy for managing symptoms as assessed by the PROMIS self-efficacy for managing symptoms short form (8a)
Time Frame: Baseline, 30 days
The PROMIS self-efficacy for managing symptoms form has a T-score range of 22 to 63. For PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured.
Baseline, 30 days
Change in stress as assessed by the Perceived Stress Scale (PSS)
Time Frame: Baseline, 30 days
The PSS has a score range from 0-40. Higher scores indicate higher perceived stress.
Baseline, 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Dana DiRenzo, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2019

Primary Completion (Actual)

April 22, 2021

Study Completion (Actual)

April 22, 2021

Study Registration Dates

First Submitted

April 29, 2019

First Submitted That Met QC Criteria

May 1, 2019

First Posted (Actual)

May 6, 2019

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00199546

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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