Viewing Study NCT03937856


Ignite Creation Date: 2025-12-24 @ 11:16 PM
Ignite Modification Date: 2026-01-01 @ 12:40 PM
Study NCT ID: NCT03937856
Status: TERMINATED
Last Update Posted: 2021-04-26
First Post: 2019-04-29
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Smartphone Mindfulness Meditation for Patients With Rheumatic Diseases
Sponsor: Johns Hopkins University
Organization:

Study Overview

Official Title: Smartphone App Mindfulness-Based Intervention for Patients With Rheumatic Diseases
Status: TERMINATED
Status Verified Date: 2021-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: PI is leaving the institution
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: