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Smartphone Mindfulness Meditation for Patients With Rheumatic Diseases

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ClinicalTrials.gov Identifier: NCT03937856
Recruitment Status : Enrolling by invitation
First Posted : May 6, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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 Intervention/treatment Phase
Inflammatory Arthritis Scleroderma Myositis Sjogren's Syndrome Systemic Lupus Erythematosus Vasculitis Behavioral: Calm- Mindfulness Meditation smartphone application Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 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 7, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021


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.



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 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937856


Locations
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United States, Maryland
Johns Hopkins Bayview
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Clifton Bingham, III, MD Johns Hopkins University

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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: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Vasculitis
Sjogren's Syndrome
Rheumatic Diseases
Collagen Diseases
Myositis
Arthritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases