MyVoice:Rheum Decision Aid for Women With Rheumatic Diseases

University of Pittsburgh

Status: Completed

Conditions: Physician-Patient Relations; Contraception; Rheumatic Diseases

Treatments: Other: Pamphlet; Other: MyVoice:Rheum

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04879745

STUDY20060240

K23AR075057-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Decision Aid Users

Experimental group

Description:

Patients with a rheumatic disease who are given access to the MyVoice:Rheum decision aid

Treatment:

Other: MyVoice:Rheum

Pamphlet Users

Active Comparator group

Description:

Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning

Treatment:

Other: Pamphlet