Skip to main content
OpenTrials
Completed

NCT Number: NCT04879745

MyVoice:Rheum Decision Aid for Women With Rheumatic Diseases

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatic Diseases Behavior Coitus Connective Tissue Diseases Contraception Musculoskeletal Diseases Physician-Patient Relations Sexual Behavior Skin and Connective Tissue Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Falk Rheumatology Clinic, Pittsburgh, Pennsylvania, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MyVoice:Rheum

Other

Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA).

Pamphlet

Other

Participants in this arm will be given a copy of an existing patient pamphlet

Primary outcomes

  1. Acceptability of Intervention

    Time frame: 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.

  2. Intervention Appropriateness Measure

    Time frame: 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.

  3. System Usability Scale

    Time frame: 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.

Other outcomes

  1. Reproductive Knowledge Assessment for Women With Rheumatic Diseases (ReproKnow)

    Time frame: T2 (within 24 hours of intervention and appointment) compared to T0 (baseline)

    Rheumatology-specific reproductive health knowledge was assessed via ReproKnow, a measure developed and preliminarily validated by our team that covers domains of contraception safety and efficacy, pregnancy management, pre-conception planning, medication safety, fertility; a score of nine indicates the highest level of reproductive knowledge

  2. Perceived Efficacy in Patient-Physician Interactions

    Time frame: T2 (within 24 hours of intervention and appointment) compared to T0 (baseline)

    Self-reported efficacy in communicating with providers was assessed using a modified version of the validated five-item Perceived Efficacy in Patient-Provider Interactions (PEPPI) scale. Five-item measure with 5-point Likert scale questions from 1 (not at all confident) to 5 (very confident). Aggregate score is calculated by taking the individual item scores together and dividing by 5, with higher score indicating higher perceived efficacy in communicating with providers.

  3. Participant Number of Pregnancies During Study

    Time frame: T3 (three months post-intervention)

    Assessed by participant-reported survey responses to a Yes/No item about whether a pregnancy has occurred since enrollment.

  4. Quantity and Quality of Reproductive Health Conversation With Rheumatologist

    Time frame: T2 (within 24 hours of intervention and appointment)

    Three-item measure. Did you talk to your rheumatologist about family planning today- yes/no; Did you make a decision related to family planning- yes/no; what was the family planning decision you made today? (Not Reported)

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

A Pilot Study of the MyVoice:Rheum Decision Aid to Address the Reproductive Health Needs of Women With Rheumatic Diseases

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 10, 2021
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.