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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Smartphone Mindfulness Meditation for Patients With Rheumatic Diseases

Clinicaltrials.gov identifier NCT03937856

Recruitment Status Terminated (PI is leaving the institution)

First Posted May 6, 2019

Last update posted April 26, 2021

Study Description

Brief summary:

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.

  • Condition or Disease:Inflammatory Arthritis
    Scleroderma
    Myositis
    Sjogren's Syndrome
    Systemic Lupus Erythematosus
    Vasculitis
  • Intervention/Treatment: Behavioral: Calm- Mindfulness Meditation smartphone application
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Actual Enrollment: 49 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Participants who choose the intervention arm will be asked to use the Calm application for 30 days.
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Smartphone App Mindfulness-Based Intervention for Patients With Rheumatic Diseases
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: April 2021
  • Actual Study Completion Date: April 2021
Arms and interventions
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.
Outcome Measures
  • Primary Outcome Measures: 1. 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. 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.
  • Secondary Outcome Measures: 1. 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.
  • 2. 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.
  • 3. 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.
  • 4. 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.
  • 5. 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.
  • 6. 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.
  • 7. 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.
  • 8. 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.
  • 9. 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.
  • 10. 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.
  • 11. 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.
  • 12. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts
Locations

United States, Maryland
Johns Hopkins Bayview
Baltimore

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator: Dana DiRenzo, MD Johns Hopkins University

More Information
  • Responsible Party: Johns Hopkins University
  • ClinicalTrials.gov Identifier: NCT03937856 History of Changes
  • Other Study ID Numbers: IRB00199546
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: April 26, 2021
  • Last Verified: April 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • 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: Myositis
    Sjogren's Syndrome
    Arthritis
    Rheumatic Diseases
    Vasculitis
    Lupus Erythematosus, Systemic
    Collagen Diseases