MyVoice:Rheum Decision Aid for Women With Rheumatic Diseases

April 6, 2024 updated by: Mehret Birru Talabi, University of Pittsburgh

A Pilot Study of the MyVoice:Rheum Decision Aid to Address the Reproductive Health Needs of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Lupus Center of Excellence
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Falk Rheumatology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Decision Aid Users
Patients with a rheumatic disease who are given access to the MyVoice:Rheum decision aid
Other: MyVoice:Rheum
Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA).
Active Comparator: Pamphlet Users
Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning
Other: Pamphlet
Participants in this arm will be given a copy of an existing patient pamphlet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
T2 (within 24 hours of intervention and appointment)
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.
T2 (within 24 hours of intervention and appointment)
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.
T2 (within 24 hours of intervention and appointment)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
T2 (within 24 hours of intervention and appointment) compared to T0 (baseline)
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.
T2 (within 24 hours of intervention and appointment) compared to T0 (baseline)
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.
T3 (three months post-intervention)
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)
T2 (within 24 hours of intervention and appointment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

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

Investigators

  • Principal Investigator: Mehret S Birru Talabi, MD, PhD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

May 4, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 6, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20060240
  • K23AR075057-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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