Smartphone Mindfulness Meditation for Patients With Rheumatic Diseases

Study Overview
=================
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.

Official Title
-----------------
Smartphone App Mindfulness-Based Intervention for Patients With Rheumatic Diseases

Conditions
-----------------
Inflammatory Arthritis, Scleroderma, Myositis, Sjogren's Syndrome, Systemic Lupus Erythematosus, Vasculitis

Intervention / Treatment
-----------------
* Behavioral: Calm- Mindfulness Meditation smartphone application


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants who choose the intervention arm will be asked to use the Calm application for 30 days.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* 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.<br>|
| No Intervention: Control group<br>Usual care participants. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 
| 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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) | 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) | 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) | The PSS has a score range from 0-40. Higher scores indicate higher perceived stress. | Baseline, 30 days |