Systemic Lupus ErythematosusNCT05426902

Utilizing Qualitative and Quantitative Methods to Understand a New Model of Type 1 and 2 Systemic Lupus Erythematosus (SLE)

A study testing SLE@Duke in people with Systemic Lupus Erythematosus, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to pilot test SLE@Duke, a set of tools to implement the Type 1 \& 2 SLE Model in a clinical setting, as well as to gain an in-depth understanding of providers experiences using the intervention during clinic visits with patients with systemic lupus erythematosus. 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?: SLE@Duke
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 3 Jan 2022to 30 Jun 2022
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

All providers in Duke Rheumatology who practice outside of the Duke Lupus Clinic are eligible.
Patients are eligible to participate if they have an established diagnosis of SLE and are followed in Duke Rheumatology.
All patients with a SLE diagnosis will be included in the analysis. SLE diagnosis will be based on an ICD-10 code for SLE (M32.1*, M32.8, M32.9) in the EMR.

Who cannot join

New patients will be excluded

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27710

Other trials in United States

About this study

This record represents Aim 3 of this study.

Conditions: Systemic Lupus Erythematosus
Being tested: SLE@Duke
Keywords: Systemic Lupus Erythematosus
Medical subject headings: Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SLE@DukeBehavioural
SLE@Duke is a set of tools to implement the Type 1 \& 2 SLE Model in a clinical setting. The model includes an Electronic Medical Record (EMR) note template, patient-reported outcome measure, and training on how to discuss Type 1 \& 2 SLE.

Study groups in NCT05426902
Study group	Role	What they receive
SLE@Duke	Experimental	Clinic providers in Duke Rheumatology outside of the Duke Lupus Clinic are eligible to participate in the SLE@Duke intervention. Participants complete a baseline survey and training in the Type 1 \& 2 SLE Model. They are asked to perform the intervention for all eligible patients over 4 weeks. Patients complete a survey at the end of their clinic visit, and providers complete a survey at the end of the 4 week intervention period. All participating providers were invited to an in-depth interview at the end of the intervention period. Receives: Behavioral: SLE@Duke

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients' Rheumatologists Using SLE@Duke
Collected from EMR (electronic medical record). This is a composite measure that includes documentation in the clinic note of any component of SLE@Duke: (1) Type 1 \& 2 SLE Model mentioned, (2) dotphrase used, (3) Type 1 \& Type 2 PGAs (Physician Global Assessments) scored in note, (4) handout mentioned, (5) Type 2 symptoms discussed, or (6) purple sheet documented.
Measured: Baseline (month 1), intervention period (month 2)
Length of Clinic Visits
Collected from EMR (electronic medical record).
Measured: Baseline (month 1), intervention period (month 2)
Change in Physician Satisfaction With Visits With Lupus Patients, as Measured by Provider Survey
Satisfaction was measured on a scale of 1-5, where 1 = never and 5 = always in response to the statement: "After seeing a patient with lupus, I leave the exam room feeling satisfied with the encounter."
Measured: Baseline (month 1), intervention period (month 2)
Number of Lupus Patients With Assessment of Type 1 and 2 SLE in Note
Collected from EMR (electronic medical record).
Measured: Baseline (month 1), intervention period (month 2)
Number of Lupus Patients With Type 2 SLE Treatment in Note
Collected from EMR (electronic medical record).
Measured: Baseline (month 1), intervention period (month 2)
Perceived Benefits of SLE@Duke, as Measured by Provider Interviews
In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.
Measured: 4 weeks
Perceived Barriers of SLE@Duke, as Measured by Provider Interviews
In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.
Measured: 4 weeks
How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews
In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.
Measured: 4 weeks
Number of Lupus Patients With PRO (Patient-reported Outcomes) in Note
Collected from EMR (electronic medical record).
Measured: Intervention period (month 2), month 5
Difference in Perceived Quality of Visit, as Measured by Patient Survey
Each question pertaining to quality of visit was measured on a scale of 1-5, where 1 = strongly disagree and 5 = strongly agree. Different patients completed the survey at month 1 and month 2. The scores at month 1 were averaged, then subtracted from the average score at month 2.
Measured: Baseline (month 1), intervention period (month 2)
Discussion of the Type 1 and 2 Model, as Measured by Patient Survey
The patient survey asked patients to respond "Yes" or "No" in response to the statement: "My rheumatologist discussed Type 1 \& Type 2 lupus with me today."
Measured: Intervention period (month 2)
Difference in Understanding of Lupus Activity & Treatment Plan, as Measured by Patient Survey
Questions pertaining to understanding were measured on a scale of 1-5, where 1 = strongly disagree and 5 = strongly agree. Different patients completed the survey at month 1 and month 2. The scores at month 1 were averaged, then subtracted from the average score at month 2.
Measured: Baseline (month 1), intervention period (month 2)
Change in Discussion of the Type 1 and 2 Model, as Measured by Provider Survey
Discussion of the Type 1 \& 2 SLE Model was measured on a scale of 1-5, where 1 = "never" and 5 = "always" in response to the statement: "I discuss the Type 1 \& 2 SLE Model with the patient."
Measured: Baseline (month 1), intervention period (month 2)
Change in Acceptability of SLE@Duke, as Measured by Provider Survey
Questions pertaining to acceptability of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.
Measured: Baseline (month 1), intervention period (month 2)
Change in Appropriateness of SLE@Duke, as Measured by Provider Survey
Questions pertaining to the appropriateness of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.
Measured: Baseline (month 1), intervention period (month 2)
Change in Feasibility of SLE@Duke, as Measured by Provider Survey
Questions concerning feasibility of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.
Measured: Baseline (month 1), intervention period (month 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jan 202230 Jun 2022

First posted22 Jun 2022
Study start3 Jan 2022
Primary completion30 Jun 2022
Study completion30 Jun 2022

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 Duke 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: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05426902
Sponsor's protocol ID: Pro00102300
Other IDs: KL2TR002554
Status last verified: Sep 2023
First submitted: 16 Jun 2022
Last updated: 14 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus
RecruitingPhase 1
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
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RecruitingPhase 3
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A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
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RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases

All Systemic Lupus Erythematosus trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Utilizing Qualitative and Quantitative Methods to Understand a New Model of Type 1 and 2 Systemic Lupus Erythematosus (SLE)
ClinicalTrials.gov ID: NCT05426902
Acronym / sponsor ID: Pro00102300
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
Study start: 3 Jan 2022 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 22 Jun 2022 (actual)
Results: Posted 14 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This record represents Aim 3 of this study.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SLE@Duke	Experimental	Behavioral: SLE@DukeClinic providers in Duke Rheumatology outside of the Duke Lupus Clinic are eligible to participate in the SLE@Duke intervention. Participants complete a baseline survey and training in the Type 1 \& 2 SLE Model. They are asked to perform the intervention for all eligible patients over 4 weeks. Patients complete a survey at the end of their clinic visit, and providers complete a survey at the end of the 4 week intervention period. All participating providers were invited to an in-depth interview at the end of the intervention period.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

All providers in Duke Rheumatology who practice outside of the Duke Lupus Clinic are eligible.
Patients are eligible to participate if they have an established diagnosis of SLE and are followed in Duke Rheumatology.
All patients with a SLE diagnosis will be included in the analysis. SLE diagnosis will be based on an ICD-10 code for SLE (M32.1*, M32.8, M32.9) in the EMR.

Key exclusion criteria (1 listed)

New patients will be excluded

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
SLE@DukeSLE@Duke is a set of tools to implement the Type 1 \& 2 SLE Model in a clinical setting. The model includes an Electronic Medical Record (EMR) note template, patient-reported outcome measure, and training on how to discuss Type 1 \& 2 SLE.	Behavioural	SLE@Duke

Primary outcome

Number of Patients' Rheumatologists Using SLE@Duke
Time frame: Baseline (month 1), intervention period (month 2)
Collected from EMR (electronic medical record). This is a composite measure that includes documentation in the clinic note of any component of SLE@Duke: (1) Type 1 \& 2 SLE Model mentioned, (2) dotphrase used, (3) Type 1 \& Type 2 PGAs (Physician Global Assessments) scored in note, (4) handout mentioned, (5) Type 2 symptoms discussed, or (6) purple sheet documented.
Length of Clinic Visits
Time frame: Baseline (month 1), intervention period (month 2)
Collected from EMR (electronic medical record).
Change in Physician Satisfaction With Visits With Lupus Patients, as Measured by Provider Survey
Time frame: Baseline (month 1), intervention period (month 2)
Satisfaction was measured on a scale of 1-5, where 1 = never and 5 = always in response to the statement: "After seeing a patient with lupus, I leave the exam room feeling satisfied with the encounter."
Number of Lupus Patients With Assessment of Type 1 and 2 SLE in Note
Time frame: Baseline (month 1), intervention period (month 2)
Collected from EMR (electronic medical record).
Number of Lupus Patients With Type 2 SLE Treatment in Note
Time frame: Baseline (month 1), intervention period (month 2)
Collected from EMR (electronic medical record).
Perceived Benefits of SLE@Duke, as Measured by Provider Interviews
Time frame: 4 weeks
In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.
Perceived Barriers of SLE@Duke, as Measured by Provider Interviews
Time frame: 4 weeks
In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.
How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews
Time frame: 4 weeks
In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.
Number of Lupus Patients With PRO (Patient-reported Outcomes) in Note
Time frame: Intervention period (month 2), month 5
Collected from EMR (electronic medical record).
Difference in Perceived Quality of Visit, as Measured by Patient Survey
Time frame: Baseline (month 1), intervention period (month 2)
Each question pertaining to quality of visit was measured on a scale of 1-5, where 1 = strongly disagree and 5 = strongly agree. Different patients completed the survey at month 1 and month 2. The scores at month 1 were averaged, then subtracted from the average score at month 2.
Discussion of the Type 1 and 2 Model, as Measured by Patient Survey
Time frame: Intervention period (month 2)
The patient survey asked patients to respond "Yes" or "No" in response to the statement: "My rheumatologist discussed Type 1 \& Type 2 lupus with me today."
Difference in Understanding of Lupus Activity & Treatment Plan, as Measured by Patient Survey
Time frame: Baseline (month 1), intervention period (month 2)
Questions pertaining to understanding were measured on a scale of 1-5, where 1 = strongly disagree and 5 = strongly agree. Different patients completed the survey at month 1 and month 2. The scores at month 1 were averaged, then subtracted from the average score at month 2.
Change in Discussion of the Type 1 and 2 Model, as Measured by Provider Survey
Time frame: Baseline (month 1), intervention period (month 2)
Discussion of the Type 1 \& 2 SLE Model was measured on a scale of 1-5, where 1 = "never" and 5 = "always" in response to the statement: "I discuss the Type 1 \& 2 SLE Model with the patient."
Change in Acceptability of SLE@Duke, as Measured by Provider Survey
Time frame: Baseline (month 1), intervention period (month 2)
Questions pertaining to acceptability of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.
Change in Appropriateness of SLE@Duke, as Measured by Provider Survey
Time frame: Baseline (month 1), intervention period (month 2)
Questions pertaining to the appropriateness of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.
Change in Feasibility of SLE@Duke, as Measured by Provider Survey
Time frame: Baseline (month 1), intervention period (month 2)
Questions concerning feasibility of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.

Results and safety

Results posted to the registry on 14 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Providers	16	16
Patients (Survey)	49	49
Patients (EMR)	115	115

Primary outcome: Number of Patients' Rheumatologists Using SLE@Duke

Time frame: Baseline (month 1), intervention period (month 2). Count of participants. Unit: Participants

Measure	Patients (EMR) n = 67
Baseline	16
Intervention period	30

Patients (EMR): p <0.0001, Fisher Exact

Population analysed: Only applies to the Patients (EMR) group. 36 patient medical records were reviewed during the 4-week baseline period. 31 patient medical records were reviewed during the 4-week intervention period.

Primary outcome: Length of Clinic Visits

Time frame: Baseline (month 1), intervention period (month 2). Mean (Standard Deviation). Unit: minutes

Measure	Patients (EMR) n = 67
Baseline (month 1)	67.8 (22.4)
Intervention period (month 2)	70.9 (28.8)

Patients (EMR): p = 0.6, t-test, 2 sided

Primary outcome: Change in Physician Satisfaction With Visits With Lupus Patients, as Measured by Provider Survey

Time frame: Baseline (month 1), intervention period (month 2). Mean (Standard Deviation). Unit: score on a scale

Measure	Providers n = 12
Value	0.44 (0.73)

Providers: p = 0.2, t-test, 2 sided

Population analysed: Participants who completed the baseline and follow-up surveys. Only applies to the Providers group.

Primary outcome: Number of Lupus Patients With Assessment of Type 1 and 2 SLE in Note

Time frame: Baseline (month 1), intervention period (month 2). Count of participants. Unit: Participants

Measure	Patients (EMR) n = 67
Baseline (month 1)	0
Intervention period (month 2)	27

Patients (EMR): p <0.0001, Fisher Exact

Adverse events

Time frame: 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Providers	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Patients (Survey)	0 of 49 (0%)	0 of 49 (0%)	0 of 49
Patients (EMR)	0 of 115 (0%)	0 of 115 (0%)	0 of 115

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Systemic Lupus Erythematosus

Active, not recruitingPhase 2
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
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RecruitingPhase 1
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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.

Amanda Eudy, PhD principal investigator

Duke 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 SLE@Duke in people with Systemic Lupus Erythematosus, run by Duke 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 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 14 Sep 2023. 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 14 Sep 2023). 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?

Number of Patients' Rheumatologists Using SLE@Duke (time frame: Baseline (month 1), intervention period (month 2)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05426902.

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 14 Sep 2023.