N/A
N=1,895
Implementing the Decision-Aid for Lupus (IDEAL Strategy)
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT03735238 ↗Enrolled (actual)
1,895
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Penetration/Reach: Number of Eligible Participants at Each Clinical Site Who Enrolled Divided by the Number of Eligible Participants at Each Clinical Site, Expressed as Overall Percent — 96; 725; 121; 104 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- SMILE Computerized Decision-Aid (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Penetration/Reach: Number of Eligible Participants at Each Clinical Site Who Enrolled Divided by the Number of Eligible Participants at Each Clinical Site, Expressed as Overall Percent |
96; 725; 121; 104; 105; 88 | — |
| SECONDARY Perceived Acceptability of Intervention Measure (AIM) by Clinic Personnel for the SLE Patient Decision-aid |
3.53; 3.84; 3.63 | — |
| SECONDARY Perceived DA Implementation Success by Clinic Personnel for the SLE Patient Decision-aid |
3.41; 3.54; 3.47 | — |
| SECONDARY Perceived DA Permanence by Clinic Personnel for the SLE Patient Decision-aid |
3.22; 3.02; 3.11 | — |
| SECONDARY Perceived Intervention Appropriateness Measure (IAM) by Clinic Personnel for the SLE Patient Decision-aid |
3.43; 3.76; 3.64 | — |
| SECONDARY Perceived Feasibility of Intervention Measure (FIM) by Clinic Personnel for the SLE Patient Decision-aid |
3.44; 3.61; 3.53 | — |
| SECONDARY Patient Decisional Conflict Scale Related to Medication Treatment Decision-making for SLE Medications Including the Immunosuppressive Medications and Biologics After Viewing the SLE Patient Decision-aid |
19.48; 21.77; 20.23 | — |
| SECONDARY Patient-reported Interpersonal Processes of Care for Patient-Physician Communication After Viewing the SLE Patient Decision-aid |
82.19; 81.88; 82.34 | — |
| SECONDARY Patient Satisfaction for SLE Patient Decision-aid |
4.41; 4.44; 4.44 | — |
| SECONDARY Patient Time for Reviewing SLE Patient Decision-aid |
23; 22.44; 21.63 | — |
| SECONDARY Patient Preparation for Decision Making Assessed After Viewing the SLE Patient Decision-aid |
74.44 | — |
| SECONDARY Patient Acceptability of the SLE Patient Decision-Aid |
3.26 | — |
| SECONDARY Patient Feasibility of the SLE Patient Decision-Aid |
4.33 | — |
| SECONDARY Number of Participants Who Perceived the SLE Patient Decision-Aid to be Useful |
1640; 1448 | — |
Summary
The study will attempt to put into practice a shared decision making (SDM) strategy, using an individualized, computerized decision- aid (DA) for Systemic lupus erythematosus (SLE).
Eligibility Criteria
Patient Inclusion Criteria:
- Adults with a diagnosis of Systemic Lupus Erythematosus (SLE) by a rheumatologist
Patient Exclusion Criteria:
- No diagnosis of lupus, not English or Spanish speaking, visually impaired, altered mental status
Data sourced from ClinicalTrials.gov (NCT03735238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.