Rheumatoid ArthritisNCT03773471
A Multi-Center Clinical Trial to Determine the Impact of a Mobile Health Application on Rheumatoid Arthritis Shared Decision Making
A study testing Mobile Health App in people with Rheumatoid Arthritis, run by Mayo Clinic at 2 sites in United States.
Trial summary
The overall goal is to improve shared decision-making (SDM) about treatment options and thereby enhance disease outcomes and health-related quality of life (HRQOL) for patients with rheumatoid arthritis (RA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Mobile Health App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Oct 2020to 21 Jun 2023
- 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
- Age ≥ 18 years.
- Fulfillment of the ACR/EULAR 2010 classification criteria for RA [9].
- Moderate or high disease activity, according to CDAI ≥ 10, at the baseline visit.
- Intent to modify DMARD therapy (i.e., adding a DMARD, switching to a new DMARD, or changing DMARD dosage) by the patient and HCP.
Who cannot join
- Current or previous use of ArthritisPower™ by the patient.
- Lack of access to an ArthritisPower™ compatible device (e.g., smartphone, tablet, or computer)
- Inability or unwillingness to participate with using the ArthritisPower™ app for this study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Michigan Medicine - Rheumatology
Ann Arbor, Michigan, 48109-5358
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Multi-Center Cluster Randomized Controlled Clinical Trial to Determine the Impact of a Mobile Health Application on Rheumatoid Arthritis Shared Decision Making
The overall goal is to improve shared decision-making (SDM) about treatment options and thereby enhance disease outcomes and health-related quality of life (HRQOL) for patients with rheumatoid arthritis (RA). The objective of this study is to engage patients in using the ArthritisPower application on a weekly basis during the time between clinic appointments for collection of data on self-reported disease activity and patient-reported outcomes (PROs), and to display the data using an iPad to the patients and their rheumatology health care providers (HCPs) at the point of care for SDM.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Mobile Health App
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health AppBehavioural
ArthritisPower App
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Standard of care |
| Intervention Arm | Experimental | Mobile Health App Receives: Behavioral: Mobile Health App |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Determine the impact of ArthritisPower™ integration into the clinical evaluation of patients with RA on the primary endpoint of clinical improvement as defined by the continuous change in the Clinical Disease Activity Index (CDAI) (1).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start20 Oct 2020
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John M. Davis, III, Mayo Clinic
- Investigators
- John M Davis, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773471
- Sponsor's protocol ID
- 17-005947
- Status last verified
- Jun 2023
- First submitted
- 10 Dec 2018
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Cluster Randomized Controlled Clinical Trial to Determine the Impact of a Mobile Health Application on Rheumatoid Arthritis Shared Decision Making
- ClinicalTrials.gov ID
- NCT03773471
- Acronym / sponsor ID
- 17-005947
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 12 Dec 2018 (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.
The overall goal is to improve shared decision-making (SDM) about treatment options and thereby enhance disease outcomes and health-related quality of life (HRQOL) for patients with rheumatoid arthritis (RA). The objective of this study is to engage patients in using the ArthritisPower application on a weekly basis during the time between clinic appointments for collection of data on self-reported disease activity and patient-reported outcomes (PROs), and to display the data using an iPad to the patients and their rheumatology health care providers (HCPs) at the point of care for SDM.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Standard of care |
| Intervention Arm | Experimental | Behavioral: Mobile Health AppMobile Health App |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Fulfillment of the ACR/EULAR 2010 classification criteria for RA [9].
- Moderate or high disease activity, according to CDAI ≥ 10, at the baseline visit.
- Intent to modify DMARD therapy (i.e., adding a DMARD, switching to a new DMARD, or changing DMARD dosage) by the patient and HCP.
Key exclusion criteria (3 listed)
- Current or previous use of ArthritisPower™ by the patient.
- Lack of access to an ArthritisPower™ compatible device (e.g., smartphone, tablet, or computer)
- Inability or unwillingness to participate with using the ArthritisPower™ app for this study
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 |
|---|---|---|
| Mobile Health AppArthritisPower App | Behavioural | Intervention Arm |
Primary outcome
- Determine the impact of ArthritisPower™ integration into the clinical evaluation of patients with RA on the primary endpoint of clinical improvement as defined by the continuous change in the Clinical Disease Activity Index (CDAI) (1).
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Rheumatoid 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 recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
John M Davis principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health App in people with Rheumatoid Arthritis, run by Mayo Clinic at 2 sites 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 3 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: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
- Determine the impact of ArthritisPower™ integration into the clinical evaluation of patients with RA on the primary endpoint of clinical improvement as defined by the continuous change in the Clinical Disease Activity Index (CDAI) (1). (time frame: 24 months). 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 22 Jun 2023.