Clinical trial NCT03937856: Smartphone Mindfulness Meditation for Patients With Rheumatic Diseases
Official title: Smartphone App Mindfulness-Based Intervention for Patients With Rheumatic Diseases
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Inflammatory Arthritis
Scleroderma
Myositis
Sjogren's Syndrome
Systemic Lupus Erythematosus
Vasculitis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants who choose the intervention arm will be asked to use the Calm application for 30 days.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of participants recruited
timeFrame: 2 years
measure: Total number of minutes per participant
timeFrame: 30 days
Secondary outcomes:
measure: Change in Anxiety as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) Global-29 profile
timeFrame: Baseline, 30 days
measure: Change in Depression as assessed by the PROMIS Global-29 profile
timeFrame: Baseline, 30 days
measure: Change in Fatigue as assessed by the PROMIS Global-29 profile
timeFrame: Baseline, 30 days
measure: Change in Physical Function as assessed by the PROMIS Global-29 profile
timeFrame: Baseline, 30 days
measure: Change in Social participation as assessed by the PROMIS Global-29 profile
timeFrame: Baseline, 30 days
measure: Change in Pain interference as assessed by the PROMIS Global-29 profile
timeFrame: Baseline, 30 days
measure: Change in Sleep disturbance as assessed by the PROMIS Global-29 profile
timeFrame: Baseline, 30 days
measure: Change in Anxiety as assessed by the PROMIS anxiety computer adaptive testing (CAT)
timeFrame: Baseline, 30 days
measure: Change in Depression as assessed by the PROMIS depression CAT
timeFrame: Baseline, 30 days
measure: Change in Self-Efficacy for managing emotions as assessed by the PROMIS self-efficacy for managing emotions short form (8a)
timeFrame: Baseline, 30 days
measure: Change in Self-Efficacy for managing symptoms as assessed by the PROMIS self-efficacy for managing symptoms short form (8a)
timeFrame: Baseline, 30 days
measure: Change in stress as assessed by the Perceived Stress Scale (PSS)
timeFrame: Baseline, 30 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Dana DiRenzo, MD
role: PRINCIPAL_INVESTIGATOR
References: