Smartphone Mindfulness Meditation for Patients With Rheumatic Diseases

Johns Hopkins University

Status: Terminated

Conditions: Myositis; Sjogren's Syndrome; Scleroderma; Inflammatory Arthritis; Vasculitis; Systemic Lupus Erythematosus

Treatments: Behavioral: Calm- Mindfulness Meditation smartphone application

Study type: Interventional

Funder types: Other

Identifiers

NCT03937856

IRB00199546

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Intervention group

Experimental group

Description:

Participant groups will include enrolled patients with rheumatic disease who use the smartphone mindfulness meditation application for 30 days.

Treatment:

Behavioral: Calm- Mindfulness Meditation smartphone application

Control group

No Intervention group

Description:

Usual care participants.