| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Inflammatory Arthritis Scleroderma Myositis Sjogren's Syndrome Systemic Lupus Erythematosus Vasculitis | Behavioral: Calm- Mindfulness Meditation smartphone application | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 49 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Participants who choose the intervention arm will be asked to use the Calm application for 30 days. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Smartphone App Mindfulness-Based Intervention for Patients With Rheumatic Diseases |
| Actual Study Start Date : | May 7, 2019 |
| Actual Primary Completion Date : | April 22, 2021 |
| Actual Study Completion Date : | April 22, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Intervention group
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
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.
|
|
No Intervention: Control group
Usual care participants.
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Established patients of the Johns Hopkins (JH) Rheumatology Division will be eligible for participation.
Exclusion Criteria:
| United States, Maryland | |
| Johns Hopkins Bayview | |
| Baltimore, Maryland, United States, 21224 | |
| Principal Investigator: | Dana DiRenzo, MD | Johns Hopkins University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 29, 2019 | ||||
| First Posted Date ICMJE | May 6, 2019 | ||||
| Last Update Posted Date | April 26, 2021 | ||||
| Actual Study Start Date ICMJE | May 7, 2019 | ||||
| Actual Primary Completion Date | April 22, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Smartphone Mindfulness Meditation for Patients With Rheumatic Diseases | ||||
| Official Title ICMJE | Smartphone App Mindfulness-Based Intervention for Patients With Rheumatic Diseases | ||||
| 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 Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Intervention Model Description: Participants who choose the intervention arm will be asked to use the Calm application for 30 days. Masking: None (Open Label)Primary Purpose: Treatment |
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| Condition ICMJE |
|
||||
| Intervention ICMJE | Behavioral: 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.
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Actual Enrollment ICMJE |
49 | ||||
| Original Estimated Enrollment ICMJE |
264 | ||||
| Actual Study Completion Date ICMJE | April 22, 2021 | ||||
| Actual Primary Completion Date | April 22, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria: Established patients of the Johns Hopkins (JH) Rheumatology Division will be eligible for participation.
Exclusion Criteria:
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03937856 | ||||
| Other Study ID Numbers ICMJE | IRB00199546 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Johns Hopkins University | ||||
| Study Sponsor ICMJE | Johns Hopkins University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Johns Hopkins University | ||||
| Verification Date | April 2021 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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