MyVoice:Rheum Decision Aid for Women With Rheumatic Diseases

  • STATUS
    Recruiting
  • End date
    Jul 26, 2022
  • participants needed
    50
  • sponsor
    University of Pittsburgh
Updated on 26 August 2021

Summary

This is a pilot trial to assess feasibility and acceptability of MyVoice vs. a patient pamphlet among female patients ages 18-44 (n=50) who receive rheumatology care.

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

Description

The pilot will demonstrate if the MyVoice 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 decision aid (n=38). Women in the control arm (n=12) will receive a widely-accessible paper-based pamphlet about pregnancy, which, similarly to MyVoice, targets women with a broad range of rheumatic diseases.

Rheumatologists will have no obligatory actions; however, if one or more of their patients completed the study, they will be emailed an anonymous survey about their experiences with the study and related patient encounters. This will occur 2 weeks after the final patient participant completes the study. Rheumatologists will not be informed by study personnel which of their patients participated in the study.

Details
Condition Contraception, Rheumatism, CONNECTIVE TISSUE DISEASE, Musculoskeletal Disease, Physician-Patient Relations, rheumatic diseases, rheumatic, contraceptive method, birth control method
Treatment Pamphlet, MyVoice:Rheum, Provider Experience
Clinical Study IdentifierNCT04879745
SponsorUniversity of Pittsburgh
Last Modified on26 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients must have at least one of four rheumatic diseases diagnosed by a
rheumatologist: rheumatoid arthritis (RA), systemic sclerosis (SSc), myositis
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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