Clinical trial NCT05509322: Care Expansion Across Remote Environments - Sub-Study of the SELF-GYN1 Trial
Official title: Care Expansion Across Remote Environments - Substudy of the SELF-GYN [Sonograms Enable Looking Forward - Get Your iNformation] Extension - I Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Fertility Risk
Lead sponsor: Turtle Health, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-22
Enrollment: 0
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, interventional, multi-arm real-world study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This real-world, interventional sub-study will evaluate the impact of potential payer subsidies for Turtle Health at-home consults on subsequent interactions with the healthcare system within select sub-populations of interest.

Detailed description: The present study is a sub-study of the SELF-GYN1 study. The SELF-GYN1 study is a multicenter study designed to evaluate the efficacy and safety of the use of the Turtle Health Ultrasound Scanner for the acquisition of transvaginal ultrasound images by a study participant, with no previous training, in her home when guided by real-time remote supervision from a qualified and specially trained ultrasound technologist.

In addition to the main questions of the SELF-GYN1 study, additional questions related to patient decision-making and pricing dynamics for patients who purchase patient's decisions to purchase a fertility consult alongside enrolling in the SELF-GYN1 trial, will be studied at Mayo Clinic, through providing subsidies for the purchasing of the fertility consult.

Eligibility criteria: Inclusion Criteria:

* All inclusion criteria from the SELF-GYN1 trial apply
* Participant in Mayo Clinic health system
* Lives in MN
* Belongs to a sub-population targeted for enrollment that has not yet met its enrollment target
* Consent to participate in electronic health record monitoring and outreach

Exclusion Criteria:

* All exclusion criteria from the SELF-GYN1 trial apply
* Planning to move away from MN in the next year

Primary outcomes:
measure: Image quality
timeFrame: 6 weeks
Secondary outcomes:
measure: False positives
timeFrame: 6 weeks
measure: Recalled Net Promoter Score
timeFrame: 6 weeks
measure: Number of patients opening box at correct time
timeFrame: 6 weeks
measure: Number of correct patients identified
timeFrame: 6 weeks
measure: Number of patients who used probe cover
timeFrame: 6 weeks
measure: Number of patients placing probe in correct cavity
timeFrame: 6 weeks
measure: Rate of return packages sent
timeFrame: 6 weeks
measure: Rate of probes that crack
timeFrame: 6 weeks
measure: Rate of working probes
timeFrame: 6 weeks
measure: Rate of probes being reprocessed
timeFrame: 6 weeks
measure: Adverse events
timeFrame: 6 weeks
measure: Number of participants per subsidy
timeFrame: 6 months
measure: Number of couples who participate
timeFrame: 6 months
measure: Clinically significant findings
timeFrame: 6 weeks
measure: Number of IVF cycles
timeFrame: 6 months
measure: Percentage of IVF cycles
timeFrame: 6 months
measure: Number of gynecological surgeries
timeFrame: 6 months
measure: Percentage of minimally invasive gynecological surgeries
timeFrame: 6 months
measure: Percentage of gynecological surgeries
timeFrame: 12 months
measure: Number of additional TVUS
timeFrame: 6 months
measure: Number of other follow-up care
timeFrame: 6 months
measure: Percentage of follow up care per arm
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
citation: Chung EH, Petishnok LC, Conyers JM, Schimer DA, Vitek WS, Harris AL, Brown MA, Jolin JA, Karmon A, Styer AK. Virtual Compared With In-Clinic Transvaginal Ultrasonography for Ovarian Reserve Assessment. Obstet Gynecol. 2022 Apr 1;139(4):561-570. doi: 10.1097/AOG.0000000000004698. Epub 2022 Mar 10.
citation: Birch Petersen K, Maltesen T, Forman JL, Sylvest R, Pinborg A, Larsen EC, Macklon KT, Nielsen HS, Hvidman HW, Nyboe Andersen A. The Fertility Assessment and Counseling Clinic - does the concept work? A prospective 2-year follow-up study of 519 women. Acta Obstet Gynecol Scand. 2017 Mar;96(3):313-325. doi: 10.1111/aogs.13081. Epub 2017 Feb 3.
citation: Farquhar C, Ekeroma A, Furness S, Arroll B. A systematic review of transvaginal ultrasonography, sonohysterography and hysteroscopy for the investigation of abnormal uterine bleeding in premenopausal women. Acta Obstet Gynecol Scand. 2003 Jun;82(6):493-504. doi: 10.1034/j.1600-0412.2003.00191.x.