Systemic Lupus ErythematosusRheum-iCMPNCT03915652
Addressing Disparities in Lupus Care Through an Integrated Care Management Program
A study testing Rheum iCMP in people with Systemic Lupus Erythematosus, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The aim of this study is to identify lupus patients receiving care at Brigham and Women's Hospital (BWH) who are at high risk for potentially avoidable acute care utilization, inconsistent ambulatory care use, and adverse outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Rheum iCMP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2019to 20 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Meet at least 4 American College of Rheumatology criteria for systemic lupus erythematosus (SLE) or rheumatologist diagnosis of SLE
- Over the preceding 3 years, at least 1 hospitalization or ED visit related to lupus OR at least 1 rheumatology appointment no-show or same-day cancellation
- Receive their primary care at BWH
Who cannot join
- Non-English or Spanish speaker
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Addressing Disparities in Lupus Care Through an Integrated Care Management Program (Rheum-iCMP)
The aim of this study is to identify lupus patients receiving care at Brigham and Women's Hospital (BWH) who are at high risk for potentially avoidable acute care utilization, inconsistent ambulatory care use, and adverse outcomes. The investigators will invite high-risk lupus patients to participate in an intensive care management program with a nurse manager, and will determine whether this program improves receipt of high quality sustained outpatient care and reduces avoidable emergency department visits and hospitalizations. The investigators will also study the social determinants that contribute to acute care use and avoidable outcomes among lupus patients using semi-structured interviews and a photovoice method.
Read the detailed description
The aim of this study is to determine whether an intensive care management program for high-risk lupus patients (Rheum-iCMP, modeled after the highly successful BWH iCMP for primary care patients) reduces acute care utilization (emergency department (ED) visits, hospitalizations), improves rheumatology clinic appointment attendance, and ultimately improves quality of lupus care in this group. Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus.
The investigators plan to identify high-risk lupus patients in the Partners' risk contract (Medicaid, Medicare and certain commercial insurances) with BWH primary care physicians (PCPs) from three sources. First, the investigators will use the BWH Lupus Registry, which is updated regularly and includes lupus patients actively receiving care at BWH. Second, the investigators will identify lupus patients via Partners electronic medical record (EMR) using our validated lupus algorithm and look specifically at those receiving primary care within the BWH system. The investigators will link both BWH Lupus Registry patients and patients meeting our algorithm to claims data through the Population Health Repository. The investigators will then identify patients with increased healthcare utilization, including ED visits and/or hospitalizations during the preceding 3 years, and who are at risk for avoidable outcomes (rheumatology appointment no-shows/same-day cancellations within the same period). The investigators will also apply the Partners' Center for Population Health high-risk algorithm to both cohorts to identify additional high-risk patients. The investigators will then reach out to the identified patients' PCPs or their rheumatologists for approval to send a study invitation to patients or asking physicians to introduce the study to their patients with a fact sheet. Third, the investigators will ask rheumatologists to refer lupus patients who might benefit from Rheum-iCMP, since a similar referral system has been successful within BWH-wide iCMP.
The investigators plan to newly enroll 40 lupus patients aged ≥18 years old, both male and female, English-speaking, and who receive their primary care at BWH prospectively using a stepped wedge design starting first with 20 patients enrolled in Rheum-iCMP, and then with 20 additional patients enrolled 4 months later. For the second 20 patients, for the first 4 months, patients will receive educational material about lupus on a monthly basis. The investigators will invite these 40 patients to also participate in a semi-structured interview that includes asking participants ahead of time to take 10-15 photographs (with a disposable camera the investigators will provide) of their neighborhoods and homes, in order to begin a conversation about the social determinants that contribute to their care-seeking behaviors. Participants will then sit with a moderator for a ~60-90 minute semi-structured, in-depth photo-elicitation interview. Participants will be asked to 1) select the photographs for discussion, 2) contextualize each image and tell a story, 3) describe what is really happening and how it relates to their life and 4) propose suggestions for what can be done to improve any barriers described. The elicitation interviews will be audio-recorded, transcribed verbatim, and entered into Dedoose for analysis. Participation in the photographs/interview is not a requirement of being a part of Rheum-iCMP.
In addition to these 40 newly enrolled patients, the investigators expect that 100 additional adult lupus patients within the Partners system are already enrolled in BWH iCMP. Among these patients, the investigators plan to examine EMR and claims data pre and post iCMP enrollment as an observational study looking at differences in utilization. However, the investigators do not plan to ask for survey completion for this population since this iCMP program is considered standard of care and these patients are already a part of it. Because the investigators do not feel that this will involve more than minimal risk and because it would not be feasible, the investigators do not plan to consent these individuals to allow us to examine their medical records.
The investigators will compare lupus-related quality metrics, rheumatology appointment attendance, and acute care use 12 months after enrollment in rheum-iCMP as compared to 12 months before enrollment in rheum-iCMP. The investigators will collect surveys at 12 months after enrollment in rheum-iCMP. For individuals who unenrolled before the end of the 12-month study period, we will stop the chart review at the date of unenrollment. The investigators will also examine EMR and claims data when available prior to the rheum-iCMP and then for the subsequent 12-24 months during and following rheum-iCMP. For the lupus patients who are already enrolled in BWH iCMP, the investigators will separately compare measures extractable from EMRs and claims pre-iCMP, during iCMP but pre-lupus-specific iCMP nurse training, and during Rheum-iCMP (post- nurse training) for N=100. These data are observational/non-experimental and distinct from the pilot trial intervention and thus cannot be combined and will be analyzed separately.
During the intervention period, our project coordinator will set up a sustainable EPIC system for tracking appointment no-shows and SLE quality metrics (e.g. lab monitoring, contraceptive use). The investigators will collect the following surveys: medication adherence and medication beliefs using the MASRI survey and the Beliefs about Medications scale, lupus disease activity using SLAQ, mental health using the MHI-5, social determinants of health using the Partners Healthcare Social Determinants of Health (SDH) Survey, global health assessment using the PROMIS global health scale short form, and racial discrimination using the Everyday Discrimination Scale. The investigators will also collect baseline demographics information via a demographics survey. The investigators will determine acute care utilization (e.g. ED visits, hospitalizations) using partners risk contract claims data. The investigators will also use surveys at 12 months after rheum-iCMP enrollment to assess patient, iCMP nurse, and MD satisfaction. Surveys will be collected at outpatient appointments or via mail. For longer term quality metrics 12-24 months past the intervention period, the investigators will work with the Center for Population Health's team to set up a tracking system that has Partners-wide claims data linked with EMRs. For the 100 patients already enrolled in the iCMP intervention, the investigators assess changes in acute care use (ED visits and hospitalizations) and appointment no shows however this is an observational separate study and will not be compared to data from the newly enrolled patients. The investigators will also collect these data for the 40 newly enrolled patients, which will be analyzed separately as the intervention is different.
This is a pilot study. One of our primary measures is to reduce ambulatory rheumatology care no-show rates for the highest risk patients. The investigators estimate that the no-show rate is about 70% and the aim of this study is to reduce this rate to 20%. The investigators would need a total of 40 patients (20 in each arm) to have 80% power to detect this difference, which is why the target enrollment for new patients in Rheum-iCMP is 40.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Rheum iCMP
- Keywords
- minority health, prevention, vaccine, behavior, women's health, autoimmune, intervention, survey, QI/QA, outcomes (health services/delivery)
- Medical subject headings
- Lupus Erythematosus, Systemic, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rheum iCMPBehavioural
Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
| Study group | Role | What they receive |
|---|---|---|
| Rheum iCMP Wave 1 | Experimental | 20 patients enrolled immediately in Rheum iCMP Receives: Behavioral: Rheum iCMP |
| Rheum iCMP Wave 2 | Experimental | 20 patients enrolled in Rheum iCMP after 4 months; will receive monthly lupus educational materials mailed to their home during the first 4 months Receives: Behavioral: Rheum iCMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lupus-related Appointment Nonadherence
Mean change in the number of lupus-related ambulatory care visit no-shows and same-day cancellations
Measured: Mean change from 12 months prior to intervention and the 12 months during the intervention
Composite Measure of Acute Care Utilization
Mean change in the number of ED visits plus number of hospitalizations
Measured: Mean change from 12 months prior to intervention and the 12 months during the intervention
Quality of Lupus Care: SLE Quality Metric Scoring System for Adults
Percent of quality metrics from the SLE Quality Metric Scoring System for Adults remaining from baseline 12 months after the start of the intervention. The percent of needs remaining at 12 months was determined and the mean (SD) percent of remaining needs was calculated by arm. Percentages can range from 0-100, with 100 meaning that more quality metrics were not completed (worse outcome).
Measured: Percent of quality metrics remaining at 12 months
Secondary outcomes (7)
Medication Adherence Self-Report Inventory (MASRI)
Mean change in MASRI score (for lupus medications) from baseline to 12 months. Score range is 0-100. Higher scores indicate greater adherence (on a scale from 0 to 100, 100 indicating a person's rating of perfect adherence).
Measured: Mean change from baseline to 12 months after the start of the intervention.
Beliefs About Medications Survey
Mean change in Beliefs About Medications score (for lupus medications) from baseline to 12 months after the start of the intervention. Score range is 5-25. Higher scores indicate a worse outcome (higher scores indicate more negative feelings about lupus medications).
Measured: Mean change from baseline compared to 12 months after the start of the intervention
Systemic Lupus Activity Questionnaire (SLAQ)
Mean change in patient-reported lupus disease activity from baseline to 12 months using the SLAQ score. Score range is 0-46. Higher scores indicate a worse outcome (higher scores indicate more lupus disease activity).
Measured: Mean change from baseline compared to 12 months after the start of the intervention
Mental Health Inventory-5 (MHI-5)
Mean change in depressive or anxious symptoms from baseline to 12 months using the MHI-5 survey. Score range is 0-100. Higher scores indicate a better outcome (higher scores indicate better mental health).
Measured: Mean change from baseline compared to 12 months after the start of the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale Short Form
Mean change in global health from baseline to 12 months using the PROMIS global health scale short form. Score range is 9-45. Higher scores indicate a better outcome (higher scores indicate improved global health and well-being).
Measured: Mean change from baseline compared to 12 months after the start of the intervention
Social Determinants of Health (SDOH) Survey
Percent of social determinants of health (SDoH)-related needs at 12 months from baseline using the SDoH Survey. The survey range is 0-8 and the percent of remaining needs is 0-100 with 100 meaning that all of the needs remain (worse outcome).
Measured: Percent of social determinants of health-related needs remaining 12 months after the start of the intervention
Everyday Discrimination Scale
Mean change in daily discrimination encountered from baseline to 12 months using the Everyday Discrimination Scale. Score range is 0-40. Higher scores indicate a worse outcome (higher scores indicate a greater amount of discrimination encountered).
Measured: Mean change from baseline compared to 12 months after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start21 Jun 2019
- Primary completion20 Jul 2022
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Sequential
- Model description
- The investigators plan to newly enroll 40 lupus patients prospectively using a stepped wedge design starting first with 20 patients enrolled in Rheum-iCMP, and then with 20 additional patients enrolled 4 months later. For the second 20 patients, for the first 4 months, patients will receive educational material.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Partners HealthCare
- Responsible party
- Principal investigator, Candace Hillary Feldman, MD, Brigham and Women's Hospital
- Investigators
- Candace H Feldman, MD, ScD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915652
- Sponsor's protocol ID
- IRB 2019P000638
- Acronym
- Rheum-iCMP
- Status last verified
- Sep 2025
- First submitted
- 12 Mar 2019
- Last updated
- 25 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Disparities in Lupus Care Through an Integrated Care Management Program (Rheum-iCMP)
- ClinicalTrials.gov ID
- NCT03915652
- Acronym / sponsor ID
- Rheum-iCMP / IRB 2019P000638
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- minority health, prevention, vaccine, behavior, women's health, autoimmune, intervention, survey
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Partners HealthCare
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Posted 22 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to identify lupus patients receiving care at Brigham and Women's Hospital (BWH) who are at high risk for potentially avoidable acute care utilization, inconsistent ambulatory care use, and adverse outcomes. The investigators will invite high-risk lupus patients to participate in an intensive care management program with a nurse manager, and will determine whether this program improves receipt of high quality sustained outpatient care and reduces avoidable emergency department visits and hospitalizations. The investigators will also study the social determinants that contribute to acute care use and avoidable outcomes among lupus patients using semi-structured interviews and a photovoice method.
Detailed description
The aim of this study is to determine whether an intensive care management program for high-risk lupus patients (Rheum-iCMP, modeled after the highly successful BWH iCMP for primary care patients) reduces acute care utilization (emergency department (ED) visits, hospitalizations), improves rheumatology clinic appointment attendance, and ultimately improves quality of lupus care in this group. Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus.
The investigators plan to identify high-risk lupus patients in the Partners' risk contract (Medicaid, Medicare and certain commercial insurances) with BWH primary care physicians (PCPs) from three sources. First, the investigators will use the BWH Lupus Registry, which is updated regularly and includes lupus patients actively receiving care at BWH. Second, the investigators will identify lupus patients via Partners electronic medical record (EMR) using our validated lupus algorithm and look specifically at those receiving primary care within the BWH system. The investigators will link both BWH Lupus Registry patients and patients meeting our algorithm to claims data through the Population Health Repository. The investigators will then identify patients with increased healthcare utilization, including ED visits and/or hospitalizations during the preceding 3 years, and who are at risk for avoidable outcomes (rheumatology appointment no-shows/same-day cancellations within the same period). The investigators will also apply the Partners' Center for Population Health high-risk algorithm to both cohorts to identify additional high-risk patients. The investigators will then reach out to the identified patients' PCPs or their rheumatologists for approval to send a study invitation to patients or asking physicians to introduce the study to their patients with a fact sheet. Third, the investigators will ask rheumatologists to refer lupus patients who might benefit from Rheum-iCMP, since a similar referral system has been successful within BWH-wide iCMP.
The investigators plan to newly enroll 40 lupus patients aged ≥18 years old, both male and female, English-speaking, and who receive their primary care at BWH prospectively using a stepped wedge design starting first with 20 patients enrolled in Rheum-iCMP, and then with 20 additional patients enrolled 4 months later. For the second 20 patients, for the first 4 months, patients will receive educational material about lupus on a monthly basis. The investigators will invite these 40 patients to also participate in a semi-structured interview that includes asking participants ahead of time to take 10-15 photographs (with a disposable camera the investigators will provide) of their neighborhoods and homes, in order to begin a conversation about the social determinants that contribute to their care-seeking behaviors. Participants will then sit with a moderator for a ~60-90 minute semi-structured, in-depth photo-elicitation interview. Participants will be asked to 1) select the photographs for discussion, 2) contextualize each image and tell a story, 3) describe what is really happening and how it relates to their life and 4) propose suggestions for what can be done to improve any barriers described. The elicitation interviews will be audio-recorded, transcribed verbatim, and entered into Dedoose for analysis. Participation in the photographs/interview is not a requirement of being a part of Rheum-iCMP.
In addition to these 40 newly enrolled patients, the investigators expect that 100 additional adult lupus patients within the Partners system are already enrolled in BWH iCMP. Among these patients, the investigators plan to examine EMR and claims data pre and post iCMP enrollment as an observational study looking at differences in utilization. However, the investigators do not plan to ask for survey completion for this population since this iCMP program is considered standard of care and these patients are already a part of it. Because the investigators do not feel that this will involve more than minimal risk and because it would not be feasible, the investigators do not plan to consent these individuals to allow us to examine their medical records.
The investigators will compare lupus-related quality metrics, rheumatology appointment attendance, and acute care use 12 months after enrollment in rheum-iCMP as compared to 12 months before enrollment in rheum-iCMP. The investigators will collect surveys at 12 months after enrollment in rheum-iCMP. For individuals who unenrolled before the end of the 12-month study period, we will stop the chart review at the date of unenrollment. The investigators will also examine EMR and claims data when available prior to the rheum-iCMP and then for the subsequent 12-24 months during and following rheum-iCMP. For the lupus patients who are already enrolled in BWH iCMP, the investigators will separately compare measures extractable from EMRs and claims pre-iCMP, during iCMP but pre-lupus-specific iCMP nurse training, and during Rheum-iCMP (post- nurse training) for N=100. These data are observational/non-experimental and distinct from the pilot trial intervention and thus cannot be combined and will be analyzed separately.
During the intervention period, our project coordinator will set up a sustainable EPIC system for tracking appointment no-shows and SLE quality metrics (e.g. lab monitoring, contraceptive use). The investigators will collect the following surveys: medication adherence and medication beliefs using the MASRI survey and the Beliefs about Medications scale, lupus disease activity using SLAQ, mental health using the MHI-5, social determinants of health using the Partners Healthcare Social Determinants of Health (SDH) Survey, global health assessment using the PROMIS global health scale short form, and racial discrimination using the Everyday Discrimination Scale. The investigators will also collect baseline demographics information via a demographics survey. The investigators will determine acute care utilization (e.g. ED visits, hospitalizations) using partners risk contract claims data. The investigators will also use surveys at 12 months after rheum-iCMP enrollment to assess patient, iCMP nurse, and MD satisfaction. Surveys will be collected at outpatient appointments or via mail. For longer term quality metrics 12-24 months past the intervention period, the investigators will work with the Center for Population Health's team to set up a tracking system that has Partners-wide claims data linked with EMRs. For the 100 patients already enrolled in the iCMP intervention, the investigators assess changes in acute care use (ED visits and hospitalizations) and appointment no shows however this is an observational separate study and will not be compared to data from the newly enrolled patients. The investigators will also collect these data for the 40 newly enrolled patients, which will be analyzed separately as the intervention is different.
This is a pilot study. One of our primary measures is to reduce ambulatory rheumatology care no-show rates for the highest risk patients. The investigators estimate that the no-show rate is about 70% and the aim of this study is to reduce this rate to 20%. The investigators would need a total of 40 patients (20 in each arm) to have 80% power to detect this difference, which is why the target enrollment for new patients in Rheum-iCMP is 40.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators plan to newly enroll 40 lupus patients prospectively using a stepped wedge design starting first with 20 patients enrolled in Rheum-iCMP, and then with 20 additional patients enrolled 4 months later. For the second 20 patients, for the first 4 months, patients will receive educational material.
| Arm | Type | Receives |
|---|---|---|
| Rheum iCMP Wave 1 | Experimental | Behavioral: Rheum iCMP20 patients enrolled immediately in Rheum iCMP |
| Rheum iCMP Wave 2 | Experimental | Behavioral: Rheum iCMP20 patients enrolled in Rheum iCMP after 4 months; will receive monthly lupus educational materials mailed to their home during the first 4 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meet at least 4 American College of Rheumatology criteria for systemic lupus erythematosus (SLE) or rheumatologist diagnosis of SLE
- Over the preceding 3 years, at least 1 hospitalization or ED visit related to lupus OR at least 1 rheumatology appointment no-show or same-day cancellation
- Receive their primary care at BWH
Key exclusion criteria (1 listed)
- Non-English or Spanish speaker
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 |
|---|---|---|
| Rheum iCMPSelected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care. | Behavioural | Rheum iCMP Wave 1, Rheum iCMP Wave 2 |
Primary outcome
Lupus-related Appointment Nonadherence
Time frame: Mean change from 12 months prior to intervention and the 12 months during the intervention
Mean change in the number of lupus-related ambulatory care visit no-shows and same-day cancellations
Composite Measure of Acute Care Utilization
Time frame: Mean change from 12 months prior to intervention and the 12 months during the intervention
Mean change in the number of ED visits plus number of hospitalizations
Quality of Lupus Care: SLE Quality Metric Scoring System for Adults
Time frame: Percent of quality metrics remaining at 12 months
Percent of quality metrics from the SLE Quality Metric Scoring System for Adults remaining from baseline 12 months after the start of the intervention. The percent of needs remaining at 12 months was determined and the mean (SD) percent of remaining needs was calculated by arm. Percentages can range from 0-100, with 100 meaning that more quality metrics were not completed (worse outcome).
7 secondary outcomes
Medication Adherence Self-Report Inventory (MASRI)
Time frame: Mean change from baseline to 12 months after the start of the intervention.
Beliefs About Medications Survey
Time frame: Mean change from baseline compared to 12 months after the start of the intervention
Systemic Lupus Activity Questionnaire (SLAQ)
Time frame: Mean change from baseline compared to 12 months after the start of the intervention
Mental Health Inventory-5 (MHI-5)
Time frame: Mean change from baseline compared to 12 months after the start of the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale Short Form
Time frame: Mean change from baseline compared to 12 months after the start of the intervention
Social Determinants of Health (SDOH) Survey
Time frame: Percent of social determinants of health-related needs remaining 12 months after the start of the intervention
Everyday Discrimination Scale
Time frame: Mean change from baseline compared to 12 months after the start of the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Candace H Feldman, MD, ScD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rheum iCMP in people with Systemic Lupus Erythematosus, run by Brigham and Women's Hospital 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 3 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: finished, as of the sponsor's last update on 25 Sep 2025. 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?
Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lupus-related Appointment Nonadherence (time frame: Mean change from 12 months prior to intervention and the 12 months during the intervention). The study lists 3 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 25 Sep 2025.