MyVoice:Rheum Decision Aid for Women With Rheumatic Diseases

NCT04879745 | Completed Results

• 2 other identifiers: STUDY20060240K23AR075057-01A1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Rheumatic Diseases; Physician-Patient Relations; Contraception

Keywords

rheumatic diseases; shared decision-making; sexual and reproductive health; decision aids

Outcome Measures

Primary Outcomes (3)

• Acceptability of Intervention

  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

  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

  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 Outcomes (4)

• Reproductive Knowledge Assessment for Women With Rheumatic Diseases (ReproKnow)

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

• Perceived Efficacy in Patient-Physician Interactions

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

• Participant Number of Pregnancies During Study

  T3 (three months post-intervention)

Study Arms (2)

Decision Aid Users

EXPERIMENTAL

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

Other: MyVoice:Rheum

Pamphlet Users

ACTIVE COMPARATOR

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

Other: Pamphlet

Interventions

MyVoice:Rheum OTHER

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

Decision Aid Users

Pamphlet OTHER

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

Pamphlet Users

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Women who have had prior hysterectomy or sterilization, or are pregnant.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (2)

UPMC Falk Rheumatology Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Lupus Center of Excellence

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (31)

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• Birru Talabi M, Clowse MEB, Schwarz EB, Callegari LS, Moreland L, Borrero S. Family Planning Counseling for Women With Rheumatic Diseases. Arthritis Care Res (Hoboken). 2018 Feb;70(2):169-174. doi: 10.1002/acr.23267. No abstract available.

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  PMID: 33509066 BACKGROUND

• Birru Talabi M, Callegari LS, Borrero S. Redefining Primum Non Nocere to Include Reproductive Autonomy: A New Paradigm in Subspecialty Medicine. Womens Health Rep (New Rochelle). 2021 Oct 26;2(1):497-499. doi: 10.1089/whr.2021.0079. eCollection 2021.

  PMID: 34970654 BACKGROUND

• Birru Talabi M, Eudy AM, Jayasundara M, Haroun T, Nowell WB, Curtis JR, Crow-Hercher R, White CW, Ginsberg S, Clowse MEB. Pregnancy, Periods, and "The Pill": Exploring the Reproductive Experiences of Women with Inflammatory Arthritis. ACR Open Rheumatol. 2019 Apr 15;1(2):125-132. doi: 10.1002/acr2.1016. eCollection 2019 Apr.

  PMID: 31777789 BACKGROUND

• Stransky OM, Wolgemuth T, Kazmerski T, Chodoff A, Borrero S, Birru Talabi M. Contraception decision-making and care among reproductive-aged women with autoimmune diseases. Contraception. 2021 Feb;103(2):86-91. doi: 10.1016/j.contraception.2020.11.001. Epub 2020 Nov 9.

  PMID: 33181126 BACKGROUND

• Wolgemuth T, Stransky OM, Chodoff A, Kazmerski TM, Clowse MEB, Birru Talabi M. Exploring the Preferences of Women Regarding Sexual and Reproductive Health Care in the Context of Rheumatology: A Qualitative Study. Arthritis Care Res (Hoboken). 2021 Aug;73(8):1194-1200. doi: 10.1002/acr.24249. Epub 2021 Jul 14.

  PMID: 32374928 BACKGROUND

• Birru Talabi M, Clowse MEB, Blalock SJ, Hamm M, Borrero S. Perspectives of Adult Rheumatologists Regarding Family Planning Counseling and Care: A Qualitative Study. Arthritis Care Res (Hoboken). 2020 Mar;72(3):452-458. doi: 10.1002/acr.23872.

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• Birru Talabi M, Eudy AM, Jayasundara M, Haroun T, Nowell WB, Curtis JR, Crow-Hercher R, White W, Ginsberg S, Clowse MEB. Tough Choices: Exploring Medication Decision-Making During Pregnancy and Lactation Among Women With Inflammatory Arthritis. ACR Open Rheumatol. 2021 Jul;3(7):475-483. doi: 10.1002/acr2.11240. Epub 2021 Jun 11.

  PMID: 34114738 BACKGROUND

• Sammaritano LR, Bermas BL, Chakravarty EE, Chambers C, Clowse MEB, Lockshin MD, Marder W, Guyatt G, Branch DW, Buyon J, Christopher-Stine L, Crow-Hercher R, Cush J, Druzin M, Kavanaugh A, Laskin CA, Plante L, Salmon J, Simard J, Somers EC, Steen V, Tedeschi SK, Vinet E, White CW, Yazdany J, Barbhaiya M, Bettendorf B, Eudy A, Jayatilleke A, Shah AA, Sullivan N, Tarter LL, Birru Talabi M, Turgunbaev M, Turner A, D'Anci KE. 2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases. Arthritis Rheumatol. 2020 Apr;72(4):529-556. doi: 10.1002/art.41191. Epub 2020 Feb 23.

  PMID: 32090480 BACKGROUND

• Krishnamurti T, Birru Talabi M, Callegari LS, Kazmerski TM, Borrero S. A Framework for Femtech: Guiding Principles for Developing Digital Reproductive Health Tools in the United States. J Med Internet Res. 2022 Apr 28;24(4):e36338. doi: 10.2196/36338.

  PMID: 35482371 BACKGROUND

• Birru MS, Monaco VM, Charles L, Drew H, Njie V, Bierria T, Detlefsen E, Steinman RA. Internet usage by low-literacy adults seeking health information: an observational analysis. J Med Internet Res. 2004 Sep 3;6(3):e25. doi: 10.2196/jmir.6.3.e25.

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  PMID: 10435967 BACKGROUND

• Birru Talabi M, Callegari LS, Kazmerski TM, Krishnamurti T, Mosley EA, Borrero S. A blueprint for a new model of sexual and reproductive health care in subspecialty medicine. Health Serv Res. 2023 Feb;58(1):216-222. doi: 10.1111/1475-6773.14074. Epub 2022 Oct 11. No abstract available.

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• Pryor KP, Albert B, Desai S, Ritter SY, Tarter L, Coblyn J, Bermas BL, Santacroce LM, Dutton C, Braaten KP, Pace LE, Rexrode K, Janiak E, Feldman CH. Pregnancy Intention Screening in Patients With Systemic Rheumatic Diseases: Pilot Testing a Standardized Assessment Tool. ACR Open Rheumatol. 2022 Aug;4(8):682-688. doi: 10.1002/acr2.11449. Epub 2022 May 31.

  PMID: 35639495 BACKGROUND

• Stransky O, Hunt N, Richards JS, Talabi MB. Exploring Family Planning, Parenting, and Sexual and Reproductive Health Care Experiences of Men With Rheumatic Diseases. J Rheumatol. 2022 Mar;49(3):251-255. doi: 10.3899/jrheum.210785. Epub 2021 Nov 15.

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• Borrero S, Talabi MB, Dehlendorf C. Confronting the Medical Community's Complicity in Marginalizing Abortion Care. JAMA. 2022 Nov 1;328(17):1701-1702. doi: 10.1001/jama.2022.18328.

  PMID: 36318124 BACKGROUND

• Bermas BL, Blanco I, Blazer AD, Clowse ME, Edens C, Ramsey-Goldman R, Talabi MB. Overturning Roe v. Wade: Toppling the Practice of Rheumatology. Arthritis Rheumatol. 2022 Dec;74(12):1865-1867. doi: 10.1002/art.42336. Epub 2022 Oct 11. No abstract available.

  PMID: 36128693 BACKGROUND

• Birru Talabi M, Clowse MEB, Blalock SJ, Switzer G, Yu L, Chodoff A, Borrero S. Development of ReproKnow, a reproductive knowledge assessment for women with rheumatic diseases. BMC Rheumatol. 2019 Oct 21;3:40. doi: 10.1186/s41927-019-0091-6. eCollection 2019.

  PMID: 31660532 RESULT

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• Kazmerski TM, Stransky OM, Wright CE, Albanowski M, Pilewski JM, Talabi MB, Callegari LS, Chang JC, Abebe KZ, Miller E, Deal A, O'Leary R, Borrero S. Feasibility Testing of a Web-Based Reproductive Decision Support Tool for Cystic Fibrosis. J Cyst Fibros. 2024 May;23(3):404-411. doi: 10.1016/j.jcf.2023.10.003. Epub 2023 Oct 11.

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MeSH Terms

Conditions

Rheumatic Diseases; Coitus

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Sexual Behavior; Behavior

Limitations and Caveats

Due to an increase in telemedicine utilization over the COVID-19 pandemic, most recruitment was conducted remotely instead of in-person as originally intended. The COVID-19 pandemic coincided with our study, which may account for the low number of participants recruited.

Results Point of Contact

• Title: Dr. Mehret Birru Talabi
• Organization: University of Pittsburgh Medical Center

birrums@upmc.edu

412-383-8000

Study Officials

• Mehret S Birru Talabi, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 10, 2021
• Study Start: July 29, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 1, 2023
• Last Updated: April 30, 2024
• Results First Posted: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)