N/A
N=301
Individualized Patient Decision Making for Treatment Choices Among Minorities With Lupus
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT02319525 ↗Enrolled (actual)
301
Serious AEs
0.7%
Results posted
Jan 2017
Primary outcome: Primary: Change From Baseline in Decisional Conflict Scale Scores — 21.80; 12.69 units on a scale — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Computerized patient decision-aid (Other); Usual care (lupus pamphlet) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Decisional Conflict Scale Scores |
21.80; 12.69 | 0.005 sig |
| PRIMARY Informed Choice (Validated Instruments for Values Regarding Immunosuppressives, Knowledge About Immunosuppressives, and Treatment Decision-making) |
62; 46; 89; 101 | 0.08 |
| SECONDARY Control Preferences Scale: Patient Participation in Decision-making |
33; 28; 2; 5 | 0.252 |
| SECONDARY Patient Physician Communication (Interpersonal Processes of Care (IPC) |
83.64; 83.06 | 0.504 |
| SECONDARY Analysis of Audiotaped Physician-patient Interaction (Using the Active Patient Participation Coding Scheme (APPC)): Doctor Patient-centered Communication |
5.1; 3.7 | 0.06 |
| SECONDARY Acceptability (Number of Participants Rating Each Statement as "Excellent") |
74; 49; 64; 40; 76; 49 | 0.006 sig |
| SECONDARY Feasibility (Number of Participants Rating the Feasibility of Using Decision-aid or Pamphlet- Referred to as Education Guide in This Statement) |
1; 3; 1; 13; 73; 74 | 0.006 sig |
Summary
The study will compare the efficacy of the usual education materials to individualized computerized decision guide on decision conflict of patients with lupus nephritis making treatment decisions regarding immunosuppressive therapies.
Eligibility Criteria
Inclusion Criteria
- adult female lupus nephritis patients, currently having a flare of lupus nephritis and considering change or initiation of an immunosuppressive medication (current flare) or had had flare of lupus nephritis in the past and at risk for a future lupus nephritis flare (future flare)
Exclusion Criteria
- male; lupus but no lupus nephritis; change in lupus immunosuppressive treatment already made for current flare; end stage renal disease on dialysis; renal transplant or candidate for a renal transplant
Data sourced from ClinicalTrials.gov (NCT02319525). 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.