The Impact of the Frame™ Platform on Infertility Patient Retention and Emotional Health: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Fertility treatment initiation
研究概览
简要总结
This is a randomized, controlled pilot study evaluating an intervention of non-significant risk. Potential subjects will be women who have completed an initial new patient consultation at one of the participating fertility clinics. Approximately 400 subjects will be enrolled from multiple fertility clinics.
详细描述
All participants will complete a psychological questionnaire at enrollment. The questionnaire will include the Perceived Stress Scale (PSS), the Personal Health Questionnaire Depression Scale (PHQ-8), and the Copenhagen Multi-Centre Psychosocial Infertility- Fertility Problem Stress Scale (COMPI-FPSS). Participants will then be randomized 1:1 to the control group or intervention group. Participants in the control group will not be asked to take any additional action for six months. Participants in the intervention group will be given access to FRAME which will provide them with resources and an external care team to utilize during their fertility care. The intervention group is encouraged to use FRAME and its resources for six months. After six months, participants in both groups will complete a post-study psychological questionnaire. Data will be collected from medical records of all participants for up to nine months after enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 22 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants have completed a new patient consult at one of the participating fertility clinics
- •Participants must be able to read, write and speak English
- •Participants must have access to a smart phone and internet connection
排除标准
- •Patients who are currently using a fertility coach (in-person, remote, or online)
- •Patients planning egg freezing only
- •Patients who have received treatment at another fertility center
- •Patients planning egg donation
- •Patients currently participating in another clinical trial or study involving an intervention.
研究组 & 干预措施
Control Group
Frame Access
干预措施: Frame Access (Behavioral)
结局指标
主要结局
Fertility treatment initiation
时间窗: This will be evaluated at the end of patient's study participation, approximately 6 months post enrollment.
To observe whether the patient started fertility treatment.
次要结局
- Time to fertility treatment initiation(This will be evaluated at the end of patient's study participation, approximately 6 months post enrollment.)