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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05509049
Other study ID # LRRHWWRCT
Secondary ID IRB 2129
Status Completed
Phase N/A
First received
Last updated
Start date September 7, 2022
Est. completion date January 9, 2024

Study information

Verified date January 2024
Source Lirio
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the present randomized controlled trial is to explore the effectiveness of a 12-month well woman digital health intervention leveraging Precision Nudging - the application of behavioral science and reinforcement learning to create individualized, tailored health messaging at scale that matches the right message to the right person at the right time - in promoting behavior change. Specifically, it is hypothesized that scaling behavioral science through reinforcement learning will be more effective at motivating participants to engage with well woman messages and to schedule and to attend a well woman visit compared to a standard of care message.


Recruitment information / eligibility

Status Completed
Enrollment 30068
Est. completion date January 9, 2024
Est. primary completion date January 9, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria: - Patient of health care system. - Visit with OBGYN office in the last 36 months. - OBGYN office provider is a Women's Wellness group approved provider. Exclusion Criteria: - Completed a women's wellness within the last 366 days. - Upcoming women's wellness appointment. - Had a childbirth episode (e.g., C-section vaginal delivery, or other event, including stillbirth) within the last 3 months or has a pregnancy due date in the future. - Unsubscribed.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Precision nudging
Precision nudging (i.e., the application of behavioral science and reinforcement learning to create individualized, tailored health messaging at scale that matches the right message to the right person at the right time)
Standard of care
Standard of care communication (e.g., personalized letters and patient portal notices)

Locations

Country Name City State
United States Rochester Regional Health New York New York

Sponsors (2)

Lead Sponsor Collaborator
Lirio Rochester Regional Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of participants who attended a well woman visit 3 months
Primary Proportion of participants who attended a well woman visit 6 months
Primary Proportion of participants who attended a well woman visit 9 months
Primary Proportion of participants who attended a well woman visit 12 months
Primary Proportion of participants who scheduled a well woman visit 3 months
Primary Proportion of participants who scheduled a well woman visit 6 months
Primary Proportion of participants who scheduled a well woman visit 9 months
Primary Proportion of participants who scheduled a well woman visit 12 months
Primary Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule) 3 months
Primary Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule) 6 months
Primary Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule) 9 months
Primary Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule) 12 months
Secondary Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s) 3 months
Secondary Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s) 6 months
Secondary Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s) 9 months
Secondary Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s) 12 months
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