MyVoice:CF Decision Aid for Women With Cystic Fibrosis

NCT04825236 | Completed

• 1 other identifier: STUDY20050174
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This project is a single-center feasibility study of MyVoice:CF, a patient-facing, web-based decision aid. Aim 1) Assess the acceptability, feasibility, and usability of MyVoice:CF for women with CF and multidisciplinary adult CF providers. Aim 2) Assess the preliminary efficacy of MyVoice:CF related to patient-provider communication, shared decision-making, knowledge, and self-efficacy for women with CF related to reproductive health concerns.

Conditions

Cystic Fibrosis; Contraception; Physician-Patient Relations; Pregnancy Complications

Keywords

cystic fibrosis; shared decision-making; sexual and reproductive health

Outcome Measures

Primary Outcomes (6)

• Acceptability of Intervention

  Four-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating higher acceptability.

  Patients- T2 (within 24 hours of intervention)

• Intervention Appropriateness Measure

  Four-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating greater acceptability.

  Patients- T2 (within 24 hours of intervention)

• System Usability Scale

  Ten-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating greater usability.

  Patients- T2 (within 24 hours of intervention)

• Perceived Value of Tool to Providers

  Five-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating higher perceived value.

  Providers- T5 (6 months after recruitment ends)

• Acceptability of intervention to providers

  Four-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating higher acceptability.

  Providers- T5 (6 months after recruitment ends)

• Intervention Appropriateness Measure for providers

  Four-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating greater acceptability.

  Providers- T5 (6 months after recruitment ends)

Secondary Outcomes (15)

• ReproKnow (adapted)

  T3 (up to 12 weeks post-tool use) compared to T0 (baseline)

• Shared Decision-Making (collaboRATE)

  T3 (up to 12 weeks post-tool use) ; T4 (up to 24 weeks post-tool use)

• Perceived Efficacy in Patient-Physician Interactions

  T3 (up to 12 weeks post-tool use)

• Reproductive Self Efficacy

  T3 (up to 12 weeks post-tool use) compared to T0 (baseline)

• Change in Pregnancy Intention

  Change between T3 (up to 12 weeks post-tool use) and T0 (baseline)

Study Arms (2)

Decision Aid Users

EXPERIMENTAL

Patients with CF who are given access to the MyVoice:CF decision aid

Other: MyVoice:CF

CF Healthcare Providers

EXPERIMENTAL

Members of the adult CF care team who interact with patients who have used the decision aid

Other: MyVoice:CF

Interventions

MyVoice:CF OTHER

Participants will be given access to MyVoice:CF, a web-based decision aid (DA). This tool includes information about fertility, genetics, parenting, pregnancy, and breastfeeding within the context of cystic fibrosis (CF). The tool includes interactive elements designed to give users the ability to assess and reflect on their own reproductive goals and experiences and promote self-efficacy to engage in shared decision-making with their CF and women's health providers. Upon completion of use of the decision aid, a summary sheet is generated based on the user's interaction with the tool. This summary is supplied to the provider prior to the next appointment.

CF Healthcare Providers; Decision Aid Users

Eligibility Criteria

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

You may qualify if:

• Cisgender female
• Age 18-44 years
• English-speaking
• Diagnosed with cystic fibrosis

You may not qualify if:

• Men
• Women under 18 (this tool was not designed to appropriately address the sexual and reproductive health needs and experiences of the adolescent population)
• Patients who have no computer and internet access and would be unable to access the tool
• Patients who are unable to consent

Sponsors & Collaborators

• University of Pittsburgh: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Pregnancy Complications; Coitus

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sexual Behavior; Behavior

Study Officials

• Traci M Kazmerski, MD, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: April 1, 2021
• Study Start: July 1, 2021
• Primary Completion: February 3, 2023
• Study Completion: February 3, 2023
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)