Smartphone Mindfulness Meditation for Patients With Rheumatic Diseases

NCT ID: NCT03937856

Last Updated: 2021-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-07

Study Completion Date

2021-04-22

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Participants who choose the intervention arm will be asked to use the Calm application for 30 days.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Calm- Mindfulness Meditation smartphone application

Intervention Type BEHAVIORAL

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.

Control group

Usual care participants.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dana DiRenzo, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Bayview

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00199546

Identifier Type: -

Identifier Source: org_study_id

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