Frame Support Study

Официальное название

The Impact of the Frame™ Platform on Infertility Patient Retention and Emotional Health: A Randomized Controlled Pilot Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Frame Access
  FRAME™ provides a collaborative care platform that connects patients with evidence-based resources, education and support from a dedicated care team throughout their reproductive health care journey. More specifically, for patients exploring fertility treatment. Frame supplements the patient experience by providing patients with direct contact to board-certified fertility coaches and resources that can be accessed between appointments in a web-based application. Regular use of Frame's platform m

Первичные конечные точки

• Fertility treatment initiation [Срок оценки: This will be evaluated at the end of patient's study participation, approximately 6 months post enrollment.]

Вторичные конечные точки (1)

• Time to fertility treatment initiation [Срок оценки: This will be evaluated at the end of patient's study participation, approximately 6 months post enrollment.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Inception Fertility Research Institute — Houston

Идентификаторы

NCT: NCT07083700 · IRI-RH-2025-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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