Inflammatory ArthritisNCT03937856
Smartphone Mindfulness Meditation for Patients With Rheumatic Diseases
A study testing Calm- Mindfulness Meditation smartphone application in people with Inflammatory Arthritis and Scleroderma, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Arthritis, Scleroderma, Myositis
- What is being tested?
- Calm- Mindfulness Meditation smartphone application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2019to 22 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smartphone App Mindfulness-Based Intervention for Patients With Rheumatic Diseases
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.
Read the 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.
- Conditions
- Inflammatory Arthritis, Scleroderma, Myositis, Sjogren's Syndrome, Systemic Lupus Erythematosus, Vasculitis
- Being tested
- Calm- Mindfulness Meditation smartphone application
- Medical subject headings
- Arthritis, Scleroderma, Diffuse, Myositis, Sjogren's Syndrome, Lupus Erythematosus, Systemic, Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calm- Mindfulness Meditation smartphone applicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participant groups will include enrolled patients with rheumatic disease who use the smartphone mindfulness meditation application for 30 days. Receives: Behavioral: Calm- Mindfulness Meditation smartphone application |
| Control group | No intervention | Usual care participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days
Secondary outcomes (12)
Change in Anxiety as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) Global-29 profile
The PROMIS global-29 measure is reported as a profile. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured. The anxiety T-score (subscale of PROMIS being used here) ranges from 40-81.
Measured: Baseline, 30 days
Change in Depression as assessed by the PROMIS Global-29 profile
The PROMIS global-29 measure is reported as a profile. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured. The depression T-score (subscale of PROMIS being used here) ranges from 41-79.
Measured: Baseline, 30 days
Change in Fatigue as assessed by the PROMIS Global-29 profile
The PROMIS global-29 measure is reported as a profile. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured. The fatigue T-score (subscale of PROMIS being used here) ranges from 33-75.
Measured: Baseline, 30 days
Change in Physical Function as assessed by the PROMIS Global-29 profile
The PROMIS global-29 measure is reported as a profile. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured. The physical function T-score (subscale of PROMIS being used here) ranges from 22-56.
Measured: Baseline, 30 days
Change in Social participation as assessed by the PROMIS Global-29 profile
The PROMIS global-29 measure is reported as a profile. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured. The social participation T-score (subscale of PROMIS being used here) ranges from 29-64.
Measured: Baseline, 30 days
Change in Pain interference as assessed by the PROMIS Global-29 profile
The PROMIS global-29 measure is reported as a profile. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured. The pain interference T-score (subscale of PROMIS being used here) ranges from 41-75.
Measured: Baseline, 30 days
Change in Sleep disturbance as assessed by the PROMIS Global-29 profile
The PROMIS global-29 measure is reported as a profile. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured. The sleep disturbance T-score (subscale of PROMIS being used here) ranges from 32-73.
Measured: Baseline, 30 days
Change in Anxiety as assessed by the PROMIS anxiety computer adaptive testing (CAT)
The PROMIS anxiety CAT has a T-score range of 40 to 81. For PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured.
Measured: Baseline, 30 days
Change in Depression as assessed by the PROMIS depression CAT
The PROMIS depression CAT has a T-score range of 38 to 81. For PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured.
Measured: Baseline, 30 days
Change in Self-Efficacy for managing emotions as assessed by the PROMIS self-efficacy for managing emotions short form (8a)
The PROMIS self-efficacy for managing emotions form has a T-score range of 22 to 64. For PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured.
Measured: Baseline, 30 days
Change in Self-Efficacy for managing symptoms as assessed by the PROMIS self-efficacy for managing symptoms short form (8a)
The PROMIS self-efficacy for managing symptoms form has a T-score range of 22 to 63. For PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10. Higher scores indicate more of the trait being measured.
Measured: Baseline, 30 days
Change in stress as assessed by the Perceived Stress Scale (PSS)
The PSS has a score range from 0-40. Higher scores indicate higher perceived stress.
Measured: Baseline, 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start7 May 2019
- Primary completion22 Apr 2021
- Study completion22 Apr 2021
Why it stopped: PI is leaving the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ArthritisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants who choose the intervention arm will be asked to use the Calm application for 30 days.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana DiRenzo, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937856
- Sponsor's protocol ID
- IRB00199546
- Status last verified
- Apr 2021
- First submitted
- 29 Apr 2019
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone App Mindfulness-Based Intervention for Patients With Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT03937856
- Acronym / sponsor ID
- IRB00199546
- Conditions
- Inflammatory Arthritis, Scleroderma, Myositis, Sjogren's Syndrome, Systemic Lupus Erythematosus, Vasculitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI is leaving the institution
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 7 May 2019 (actual)
- Primary completion
- 22 Apr 2021 (actual)
- Study completion
- 22 Apr 2021 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants who choose the intervention arm will be asked to use the Calm application for 30 days.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Calm- Mindfulness Meditation smartphone applicationParticipant groups will include enrolled patients with rheumatic disease who use the smartphone mindfulness meditation application for 30 days. |
| Control group | No intervention | –Usual care participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calm- Mindfulness Meditation smartphone applicationParticipants 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. | Behavioural | Intervention group |
Primary outcome
Number of participants recruited
Time frame: 2 years
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.
Total number of minutes per participant
Time frame: 30 days
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.
12 secondary outcomes
Change in Anxiety as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) Global-29 profile
Time frame: Baseline, 30 days
Change in Depression as assessed by the PROMIS Global-29 profile
Time frame: Baseline, 30 days
Change in Fatigue as assessed by the PROMIS Global-29 profile
Time frame: Baseline, 30 days
Change in Physical Function as assessed by the PROMIS Global-29 profile
Time frame: Baseline, 30 days
Change in Social participation as assessed by the PROMIS Global-29 profile
Time frame: Baseline, 30 days
Change in Pain interference as assessed by the PROMIS Global-29 profile
Time frame: Baseline, 30 days
Change in Sleep disturbance as assessed by the PROMIS Global-29 profile
Time frame: Baseline, 30 days
Change in Anxiety as assessed by the PROMIS anxiety computer adaptive testing (CAT)
Time frame: Baseline, 30 days
Change in Depression as assessed by the PROMIS depression CAT
Time frame: Baseline, 30 days
Change in Self-Efficacy for managing emotions as assessed by the PROMIS self-efficacy for managing emotions short form (8a)
Time frame: Baseline, 30 days
Change in Self-Efficacy for managing symptoms as assessed by the PROMIS self-efficacy for managing symptoms short form (8a)
Time frame: Baseline, 30 days
Change in stress as assessed by the Perceived Stress Scale (PSS)
Time frame: Baseline, 30 days
Results and safety
The study was stopped early (reason given: PI is leaving the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Arthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana DiRenzo, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calm- Mindfulness Meditation smartphone application in people with Inflammatory Arthritis and Scleroderma, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI is leaving the institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.