Smartphone Mindfulness Meditation for Patients With Rheumatic Diseases

NCT03937856 | Terminated

• 1 other identifier: IRB00199546
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Change in Anxiety as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) Global-29 profile

  Baseline, 30 days

• Change in Depression as assessed by the PROMIS Global-29 profile

  Baseline, 30 days

• Change in Fatigue as assessed by the PROMIS Global-29 profile

  Baseline, 30 days

• Change in Physical Function as assessed by the PROMIS Global-29 profile

  Baseline, 30 days

• Change in Social participation as assessed by the PROMIS Global-29 profile

  Baseline, 30 days

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Usual care participants.

Interventions

Calm- Mindfulness Meditation smartphone application 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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Arthritis; Scleroderma, Diffuse; Myositis; Sjogren's Syndrome; Lupus Erythematosus, Systemic; Vasculitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Arthritis, Rheumatoid; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dana DiRenzo, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants who choose the intervention arm will be asked to use the Calm application for 30 days.

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 6, 2019
• Study Start: May 7, 2019
• Primary Completion: April 22, 2021
• Study Completion: April 22, 2021
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)