Smartphone Mindfulness Meditation for Patients With Rheumatic Diseases
Primary Purpose
Inflammatory Arthritis, Scleroderma, Myositis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Calm- Mindfulness Meditation smartphone application
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Arthritis
Eligibility 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
Sites / Locations
- Johns Hopkins Bayview
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Participant groups will include enrolled patients with rheumatic disease who use the smartphone mindfulness meditation application for 30 days.
Usual care participants.
Outcomes
Primary Outcome Measures
Number of participants recruited
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.
Total number of minutes per participant
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
Change in Anxiety as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) Global-29 profile
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.
Change in Depression as assessed by the PROMIS Global-29 profile
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.
Change in Fatigue as assessed by the PROMIS Global-29 profile
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.
Change in Physical Function as assessed by the PROMIS Global-29 profile
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.
Change in Social participation as assessed by the PROMIS Global-29 profile
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.
Change in Pain interference as assessed by the PROMIS Global-29 profile
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.
Change in Sleep disturbance as assessed by the PROMIS Global-29 profile
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.
Change in Anxiety as assessed by the PROMIS anxiety computer adaptive testing (CAT)
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.
Change in Depression as assessed by the PROMIS depression CAT
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.
Change in Self-Efficacy for managing emotions as assessed by the PROMIS self-efficacy for managing emotions short form (8a)
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.
Change in Self-Efficacy for managing symptoms as assessed by the PROMIS self-efficacy for managing symptoms short form (8a)
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.
Change in stress as assessed by the Perceived Stress Scale (PSS)
The PSS has a score range from 0-40. Higher scores indicate higher perceived stress.
Full Information
NCT ID
NCT03937856
First Posted
April 29, 2019
Last Updated
April 22, 2021
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT03937856
Brief Title
Smartphone Mindfulness Meditation for Patients With Rheumatic Diseases
Official Title
Smartphone App Mindfulness-Based Intervention for Patients With Rheumatic Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
PI is leaving the institution
Study Start Date
May 7, 2019 (Actual)
Primary Completion Date
April 22, 2021 (Actual)
Study Completion Date
April 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Arthritis, Scleroderma, Myositis, Sjogren's Syndrome, Systemic Lupus Erythematosus, Vasculitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants who choose the intervention arm will be asked to use the Calm application for 30 days.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participant groups will include enrolled patients with rheumatic disease who use the smartphone mindfulness meditation application for 30 days.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care participants.
Intervention Type
Behavioral
Intervention Name(s)
Calm- Mindfulness Meditation smartphone application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants recruited
Description
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.
Time Frame
2 years
Title
Total number of minutes per participant
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Change in Anxiety as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) Global-29 profile
Description
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.
Time Frame
Baseline, 30 days
Title
Change in Depression as assessed by the PROMIS Global-29 profile
Description
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.
Time Frame
Baseline, 30 days
Title
Change in Fatigue as assessed by the PROMIS Global-29 profile
Description
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.
Time Frame
Baseline, 30 days
Title
Change in Physical Function as assessed by the PROMIS Global-29 profile
Description
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.
Time Frame
Baseline, 30 days
Title
Change in Social participation as assessed by the PROMIS Global-29 profile
Description
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.
Time Frame
Baseline, 30 days
Title
Change in Pain interference as assessed by the PROMIS Global-29 profile
Description
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.
Time Frame
Baseline, 30 days
Title
Change in Sleep disturbance as assessed by the PROMIS Global-29 profile
Description
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.
Time Frame
Baseline, 30 days
Title
Change in Anxiety as assessed by the PROMIS anxiety computer adaptive testing (CAT)
Description
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.
Time Frame
Baseline, 30 days
Title
Change in Depression as assessed by the PROMIS depression CAT
Description
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.
Time Frame
Baseline, 30 days
Title
Change in Self-Efficacy for managing emotions as assessed by the PROMIS self-efficacy for managing emotions short form (8a)
Description
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.
Time Frame
Baseline, 30 days
Title
Change in Self-Efficacy for managing symptoms as assessed by the PROMIS self-efficacy for managing symptoms short form (8a)
Description
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.
Time Frame
Baseline, 30 days
Title
Change in stress as assessed by the Perceived Stress Scale (PSS)
Description
The PSS has a score range from 0-40. Higher scores indicate higher perceived stress.
Time Frame
Baseline, 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana DiRenzo, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Smartphone Mindfulness Meditation for Patients With Rheumatic Diseases
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