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| Name | Class |
|---|---|
| Reframe Health, Inc. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | ||
| Frame Access | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frame Access | Behavioral | 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 may help patients make lifestyle changes that can improve their fertility outcomes as well as boost their emotional health throughout the treatment process and reduce feelings of overwhelm and loneliness which can lead to patients dropping out of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Fertility treatment initiation | To observe whether the patient started fertility treatment. | This will be evaluated at the end of patient's study participation, approximately 6 months post enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to fertility treatment initiation | To observe the interval between study enrollment and start fertility treatment, if any. | This will be evaluated at the end of patient's study participation, approximately 6 months post enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire (PHQ-8) | Patients will complete the Patient Health Questionnaire (PHQ-8) for depression screening at baseline and end of study. Scores of 10 and above suggest the presence of Major Depressive Disorder with higher scores being more severe. | From enrollment to six months after enrollment |
Inclusion Criteria:
Exclusion Criteria:
This research is targeting patients who are the primary recipient of fertility treatment.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amber Mendoza | Contact | 346-393-2265 | amendoza@inceptionllc.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inception Fertility Research Institute | Recruiting | Houston | Texas | 77081 | United States |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Copenhagen Multi-Centre Psychosocial Infertility- Fertility Problem Stress Scale (COMPI-FPSS) |
Patients will complete the Copenhagen Multi-Centre Psychosocial Infertility- Fertility Problem Stress Scale (COMPI-FPSS) at baseline and end of study. Lower scores indicate lower stress. |
| From enrollment to 6 months after enrollment. |
| Perceived Stress Scale (PSS-10) | Patients will complete the Perceived Stress Scale (PSS-10) at baseline and end of study. Scores will be interpreted as 0-13: Low stress; 14-26: Moderate stress; 27-40: High perceived stress. | From enrollment to 6 months after enrollment. |