Clinical trial NCT04879745: MyVoice:Rheum Decision Aid for Women With Rheumatic Diseases
Official title: A Pilot Study of the MyVoice:Rheum Decision Aid to Address the Reproductive Health Needs of Women With Rheumatic Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatic Diseases
Physician-Patient Relations
Contraception
Keywords: rheumatic diseases
shared decision-making
sexual and reproductive health
decision aids
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2021-05-10
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a pilot trial to assess feasibility and acceptability of MyVoice:Rheum vs. a patient pamphlet among female patients ages 18-44 (n=40) who receive rheumatology care.

• Hypothesis: MyVoice:Rheum will be feasible and acceptable to patients who receive rheumatology care.

Detailed description: The pilot will demonstrate if the MyVoice:Rheum decision aid can be feasibly and acceptably implemented into the rheumatology context and inform operational procedures for a future hybrid effectiveness-implementation trial. Women in the intervention arm will receive the MyVoice:Rheum decision aid (n=30). Women in the control arm (n=9) will receive a widely-accessible paper-based pamphlet about pregnancy, which, similarly to MyVoice:Rheum, targets women with a broad range of rheumatic diseases.

Eligibility criteria: Inclusion Criteria:

Patients must have at least one of four rheumatic diseases diagnosed by a rheumatologist: rheumatoid arthritis (RA), systemic sclerosis (SSc), myositis, Sjogren's syndrome, vasculitis, spondyloarthritis, and systemic lupus erythematosus (SLE).

Patients must read and speak in English as a Spanish-language version of the tool has not yet been developed

Access to a smart phone, personal computer, or tablet.

Exclusion Criteria:

* Women who have had prior hysterectomy or sterilization, or are pregnant.

Primary outcomes:
measure: Acceptability of Intervention
timeFrame: T2 (within 24 hours of intervention and appointment)
measure: Intervention Appropriateness Measure
timeFrame: T2 (within 24 hours of intervention and appointment)
measure: System Usability Scale
timeFrame: T2 (within 24 hours of intervention and appointment)
Secondary outcomes:
Other outcomes:
measure: Reproductive Knowledge Assessment for Women With Rheumatic Diseases (ReproKnow)
timeFrame: T2 (within 24 hours of intervention and appointment) compared to T0 (baseline)
measure: Perceived Efficacy in Patient-Physician Interactions
timeFrame: T2 (within 24 hours of intervention and appointment) compared to T0 (baseline)
measure: Participant Number of Pregnancies During Study
timeFrame: T3 (three months post-intervention)
measure: Quantity and Quality of Reproductive Health Conversation With Rheumatologist
timeFrame: T2 (within 24 hours of intervention and appointment)
Locations:
city: Pittsburgh
country: United States
facility: UPMC Falk Rheumatology Clinic
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Lupus Center of Excellence
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Mehret S Birru Talabi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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