Women's HealthNCT05509049
Precision Nudging Drives Wellness Visit Attendance at Scale
A study testing Precision nudging in people with Women's Health and Annual Visit, run by Lirio at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women's Health, Annual Visit, Well Visit
- What is being tested?
- Precision nudging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30,068 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2022to 9 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Employing Machine Learning and Behavioral Science Solutions to Increase Women's Wellness Scheduling and Attendance: A Randomized Controlled Trial
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.
- Conditions
- Women's Health, Annual Visit, Well Visit, Health Behavior, Prevention
- Being tested
- Precision nudging, Standard of care
- Keywords
- Digital Health Intervention, Behavior Change, Reinforcement Learning, Artificial Intelligence
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision nudgingOther
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 careOther
Standard of care communication (e.g., personalized letters and patient portal notices)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Behavioral science and reinforcement learning-driven hyper-personalized messages Receives: Other: Precision nudging |
| Control | Active comparator | Standard of care message Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who attended a well woman visit
Measured: 3 months
Proportion of participants who attended a well woman visit
Measured: 6 months
Proportion of participants who attended a well woman visit
Measured: 9 months
Proportion of participants who attended a well woman visit
Measured: 12 months
Proportion of participants who scheduled a well woman visit
Measured: 3 months
Proportion of participants who scheduled a well woman visit
Measured: 6 months
Proportion of participants who scheduled a well woman visit
Measured: 9 months
Proportion of participants who scheduled a well woman visit
Measured: 12 months
Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule)
Measured: 3 months
Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule)
Measured: 6 months
Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule)
Measured: 9 months
Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule)
Measured: 12 months
Secondary outcomes (4)
Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s)
Measured: 3 months
Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s)
Measured: 6 months
Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s)
Measured: 9 months
Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start7 Sep 2022
- Primary completion9 Jan 2024
- Study completion9 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women's HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a prospective, parallel, large simple superiority randomized controlled trial using simple randomization (no blocking, no stratification).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30,068 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lirio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rochester Regional Health
- Responsible party
- Sponsor
- Investigators
- Laurie Ernest, DNP, BSN, MS, WHNP-C, Principal investigator, Rochester Regional Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509049
- Sponsor's protocol ID
- LRRHWWRCT
- Other IDs
- IRB 2129
- Status last verified
- Jan 2024
- First submitted
- 17 Aug 2022
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Employing Machine Learning and Behavioral Science Solutions to Increase Women's Wellness Scheduling and Attendance: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05509049
- Acronym / sponsor ID
- LRRHWWRCT
- Conditions
- Women's Health, Annual Visit, Well Visit, Health Behavior, Prevention
- Keywords
- Digital Health Intervention, Behavior Change, Reinforcement Learning, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30,068 participants (actual)
- Lead sponsor
- LirioIndustry (pharma, biotech, devices)
- Collaborators
- Rochester Regional Health
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This study is designed as a prospective, parallel, large simple superiority randomized controlled trial using simple randomization (no blocking, no stratification).
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Precision nudgingBehavioral science and reinforcement learning-driven hyper-personalized messages |
| Control | Active comparator | Other: Standard of careStandard of care message |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Precision nudgingPrecision 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) | Other | Treatment |
| Standard of careStandard of care communication (e.g., personalized letters and patient portal notices) | Other | Control |
Primary outcome
Proportion of participants who attended a well woman visit
Time frame: 3 months
Proportion of participants who attended a well woman visit
Time frame: 6 months
Proportion of participants who attended a well woman visit
Time frame: 9 months
Proportion of participants who attended a well woman visit
Time frame: 12 months
Proportion of participants who scheduled a well woman visit
Time frame: 3 months
Proportion of participants who scheduled a well woman visit
Time frame: 6 months
Proportion of participants who scheduled a well woman visit
Time frame: 9 months
Proportion of participants who scheduled a well woman visit
Time frame: 12 months
Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule)
Time frame: 3 months
Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule)
Time frame: 6 months
Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule)
Time frame: 9 months
Proportion of participants who scheduled a well woman visit and did not attend (and did not Cancel and/or Reschedule)
Time frame: 12 months
4 secondary outcomes
Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s)
Time frame: 3 months
Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s)
Time frame: 6 months
Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s)
Time frame: 9 months
Proportion of participants who opened and/or clicked Call-to-Action, or otherwise engaged with the communication(s)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie Ernest, DNP, BSN, MS, WHNP-C principal investigator
Rochester Regional Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precision nudging in people with Women's Health and Annual Visit, run by Lirio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who attended a well woman visit (time frame: 3 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024; AzTrials last refreshed its copy on 30 Oct 2026.