Systemic Lupus ErythematosusNCT03738826
Reducing Disparities in Medication Adherence in SLE
A study testing Behavioral Intervention in people with Systemic Lupus Erythematosus, run by Duke University at 1 site in United States.
Trial summary
This is a pilot study to assess the feasibility of using Surescripts refill data during the clinical encounter to improve medication adherence in 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?
- Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2019to 7 Jun 2020
- 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 followup patients seen at the Duke Lupus clinic
Who cannot join
- Patients not seen at the Duke Lupus Clinic
- New patients seen for the first time at the Duke Lupus Clinic
- Patients who are not prescribed any lupus medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Disparities in Medication Adherence of Patients With Systemic Lupus Erythematosus (SLE)
This is a pilot study to assess the feasibility of using Surescripts refill data during the clinical encounter to improve medication adherence in patients with systemic lupus erythematosus
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Behavioral Intervention
- Keywords
- medication adherence
- Medical subject headings
- Lupus Erythematosus, Systemic, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Lupus clinic providers will use Surescripts refill information to assess adherence level and address adherence barriers. We will assess the feasibility and acceptability of the intervention. Receives: Behavioral: Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as Measured by Number of Participants With EMR (Electronic Medical Record) Documentation of Adherence
Feasibility as measured by documentation of adherence assessment made by provider.
Measured: 12 weeks
Acceptability as Measured by Provider Survey
Acceptability as measured by provider survey, score range 1-5, with a higher score indicating that the intervention was more acceptable.
Measured: 12 weeks
Secondary outcomes (2)
Medication Adherence as Determined by Self Report
Measured: 12 weeks
Percentage of Adherent Participants as Determined by Medication Possession Ratio (MPR)
Medication Possession Ratio (MPR) = days with medication/total days. This will be determined by pharmacy refill data and calculated for 3 months (90 days). An MPR > or = 80% indicates adherence.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start2 Oct 2019
- Primary completion7 Jun 2020
- Study completion7 Jun 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Kai Sun, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738826
- Sponsor's protocol ID
- Pro00100861
- Other IDs
- 5U54MD012530-02
- Status last verified
- Jul 2026
- First submitted
- 6 Nov 2018
- Last updated
- 16 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sun K, Eudy AM, Rogers JL, Criscione-Schreiber LG, Sadun RE, Doss J, Maheswaranathan M, Barr AC, Eder L, Corneli AL, Bosworth HB, Clowse MEB. Pilot Intervention to Improve Medication Adherence Among Patients With Systemic Lupus Erythematosus Using Pharmacy Refill Data. Arthritis Care Res (Hoboken). 2023 Mar;75(3):550-558. doi: 10.1002/acr.24806. Epub 2022 Nov 11.
PubMed 34739191
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Disparities in Medication Adherence of Patients With Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT03738826
- Acronym / sponsor ID
- Pro00100861
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- medication adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 7 Jun 2020 (actual)
- Study completion
- 7 Jun 2020 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Posted 27 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to assess the feasibility of using Surescripts refill data during the clinical encounter to improve medication adherence in patients with systemic lupus erythematosus
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 |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Behavioral InterventionLupus clinic providers will use Surescripts refill information to assess adherence level and address adherence barriers. We will assess the feasibility and acceptability of the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All followup patients seen at the Duke Lupus clinic
Key exclusion criteria (3 listed)
- Patients not seen at the Duke Lupus Clinic
- New patients seen for the first time at the Duke Lupus Clinic
- Patients who are not prescribed any lupus medications
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 |
|---|---|---|
| Behavioral InterventionLupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter. | Behavioural | Intervention arm |
Primary outcome
Feasibility as Measured by Number of Participants With EMR (Electronic Medical Record) Documentation of Adherence
Time frame: 12 weeks
Feasibility as measured by documentation of adherence assessment made by provider.
Acceptability as Measured by Provider Survey
Time frame: 12 weeks
Acceptability as measured by provider survey, score range 1-5, with a higher score indicating that the intervention was more acceptable.
2 secondary outcomes
Medication Adherence as Determined by Self Report
Time frame: 12 weeks
Percentage of Adherent Participants as Determined by Medication Possession Ratio (MPR)
Time frame: Baseline, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34739191Sun K, Eudy AM, Rogers JL, Criscione-Schreiber LG, Sadun RE, Doss J, Maheswaranathan M, Barr AC, Eder L, Corneli AL, Bosworth HB, Clowse MEB. Pilot Intervention to Improve Medication Adherence Among Patients With Systemic Lupus Erythematosus Using Pharmacy Refill Data. Arthritis Care Res (Hoboken). 2023 Mar;75(3):550-558. doi: 10.1002/acr.24806. Epub 2022 Nov 11.
- Individual participant dataSharing planned: Undecided
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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.
Kai Sun 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 Behavioral Intervention 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 1 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 16 Jul 2026. 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 27 Jul 2021). 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?
Feasibility as Measured by Number of Participants With EMR (Electronic Medical Record) Documentation of Adherence (time frame: 12 weeks). 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?
On the ClinicalTrials.gov record for NCT03738826, which also lists 1 linked publication.
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 16 Jul 2026.