A Feasibility Trial of the MyVoice:CF Decision Aid to Address the Reproductive Health Needs of Women With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Perceived Value of Tool to Providers
研究概览
简要总结
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.
详细描述
This study seeks to test a decision aid created to address the disease-specific reproductive health concerns of women with cystic fibrosis. The decision aid was built out of research done by studies previously approved by the University of Pittsburgh IRB. These studies determined the information and decision support needs of women with cystic fibrosis concerning their sexual and reproductive health care.
The purpose of this study is to pilot the decision aid prototype to evaluate its feasibility, appropriateness, and acceptability.
Screening for eligibility will be conducted prior to a potential participant's visit with their CF care team. Eligible patients will be contacted via phone. Interested patients will be consented and asked to schedule a time to complete the web-based decision aid in its entirety and complete a follow up qualitative interview.
The investigators will also ask participants if they are interested in two optional activities: having their screen activity on MyVoice:CF recorded for analysis and having their next appointment with their CF team recorded for conversation analyses. The RC will explain these recordings will be de-identified prior to analysis and that no one outside of the study team will see the screen capture data, listen to the recording, or read the full transcript.
Data collection: After giving consent to participate, participants will be given the link for the baseline survey, hosted on REDCap, by the RC/RA. They will also schedule a time to 1) complete the web-based decision aid and 2) complete an exit survey about the aid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cisgender female
- •Age 18-44 years
- •English-speaking
- •Diagnosed with cystic fibrosis
排除标准
- •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
结局指标
主要结局
Perceived Value of Tool to Providers
时间窗: Providers- T5 (6 months after recruitment ends)
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.
Acceptability of Intervention
时间窗: Patients- T2 (within 24 hours 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.
Intervention Appropriateness Measure
时间窗: Patients- T2 (within 24 hours 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 greater acceptability.
System Usability Scale
时间窗: Patients- T2 (within 24 hours of intervention)
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.
Intervention Appropriateness Measure for providers
时间窗: Providers- T5 (6 months after recruitment ends)
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.
Acceptability of intervention to providers
时间窗: Providers- T5 (6 months after recruitment ends)
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.
次要结局
- Shared Decision-Making (collaboRATE)(T3 (up to 12 weeks post-tool use) ; T4 (up to 24 weeks post-tool use))
- Change in Pregnancy Intention(Change between T3 (up to 12 weeks post-tool use) and T0 (baseline))
- Quantity and quality of reproductive conversations(T3 (up to 12 weeks post-tool use) ; T4 (up to 24 weeks post-tool use))
- ReproKnow (adapted)(T3 (up to 12 weeks post-tool use) compared to T0 (baseline))
- 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))
- Participant receipt of preconception counseling(T4 (up to 24 weeks post-tool use)compared to T0 (baseline))
- Participant Desire for future pregnancy(T4 (up to 24 weeks post-tool use) compared to T0 (baseline))
- Intent to breastfeed(T4 (up to 24 weeks post-tool use) compared to T0 (baseline))
- Participant Feedback to Tool(T3 (up to 12 weeks post-tool use))
- Participant Confidence in Contraceptive Method Selection(T4 (up to 24 weeks post-tool use) compared to T0 (baseline))
- Receipt of SRH care(T4 (up to 24 weeks post-tool use) compared to T0 (baseline))
- Participant Change in Contraceptive Use(T4 (up to 24 weeks post-tool use) compared to T0 (baseline))
- Participant number of pregnancies during study(T4 (up to 24 weeks post-tool use) compared to T0 (baseline))
- Participant receipt of infertility care(T4 (up to 24 weeks post-tool use) compared to T0 (baseline))
研究者
Traci Kazmerski
Assistant Professor of Pediatrics
University of Pittsburgh