MyVoice:Rheum Decision Aid for Women With Rheumatic Diseases

Not Applicable

Completed

• Conditions: Rheumatic Diseases; Contraception; Physician-Patient Relations
• Interventions: Other: Pamphlet

• Registration Number: NCT04879745
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-05-04
• Study First Posted: 2021-05-10
• Study Start: 2021-07-29
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-01
• Results First Submitted: 2023-12-30
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-06
• Last Update Submitted: 2024-04-06
• Results First Posted: 2024-04-30
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pamphlet Users	Pamphlet	Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning

Primary Outcome Measures

Name	Time	Method
Acceptability of Intervention	T2 (within 24 hours of intervention and appointment)	Acceptability of Intervention Measure (AIM) consist of Four- item measure, Likert scales ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean of scores, with a higher score indicating higher acceptability. We assigned a feasibility threshold of ≥ 3.5 of 5, for which higher scores indicate more positive responses.
Intervention Appropriateness Measure	T2 (within 24 hours of intervention and appointment)	The validated Intervention Appropriateness Measure (IAM) consist of Four-item Likert scales ranging from 1 (completely disagree) to 5 (completely agree); we assigned a feasibility threshold of ≥ 3.5 of 5 for IAM scores, for which higher scores indicate more positive responses. Score is determined by calculating the mean, with a higher score indicating greater appropriateness.
System Usability Scale	T2 (within 24 hours of intervention and appointment)	Usability was assessed via summary scores from the System Usability Scale (SUS), which consists of a 10-item Likert scale with scores ranging from 0-100; overall score calculated by finding the mean of items on scale. We set a threshold of scores \>80.3 as 'A'/excellent and 68-80.3 as 'B'/very good, consistent with standard rating for the SUS.

Trial Locations

Locations (2)

UPMC Falk Rheumatology Clinic; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC Lupus Center of Excellence; 🇺🇸 Pittsburgh, Pennsylvania, United States