Caria App for Menopause

Overseen By Jennifer Duffecy, PhD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: None

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mobile app, the Caria app, can alleviate menopause symptoms such as hot flashes, mood swings, and sleep problems. The app provides education, goal-setting, social support, and relaxation techniques. Participants will use the app to track their symptoms over time and assess any improvements in their quality of life. Women experiencing bothersome hot flashes or night sweats, depression, anxiety, or sleep issues, and who own an Apple device, can join this study. As an unphased trial, this study presents a unique opportunity to explore innovative solutions for managing menopause symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a mobile app to manage menopause symptoms, so it's likely you can continue your medications, but you should confirm with the trial organizers.

What prior data suggests that this mobile app is safe for reducing menopause symptoms?

Research has shown that the Caria app safely manages menopause symptoms. In past studies, women used the app to track symptoms, gain health insights, and connect with others. No negative effects have been reported from using the app. As a digital tool, it involves no drugs or physical treatments, making it easy to use. Users can learn about menopause, track symptoms, and find social support, all through their smartphone. Overall, the Caria app offers a risk-free way to manage menopause symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional menopause treatments that often focus on hormone replacement therapy or medications to relieve symptoms, the Caria app offers a digital, holistic approach. It combines education, symptom tracking, cognitive behavioral techniques, and social support, all conveniently delivered through a smartphone app. Researchers are excited about this treatment because it empowers women to manage their symptoms independently and could offer a non-pharmacological alternative that minimizes side effects. The app's interactive features and reminders aim to enhance user engagement and support long-term symptom management.

What evidence suggests that this trial's treatments could be effective for menopause symptoms?

Research has shown that the Caria app, available to participants in this trial, helps reduce menopause symptoms. In one study, 85% of women using Caria reported feeling better. The app offers features such as education, symptom tracking, and techniques to manage menopause symptoms. Another group in this trial will receive menopause education materials from the North American Menopause Society. A study also confirmed that Caria can help with hot flashes and mood-related symptoms. These findings suggest that Caria can be a helpful tool for managing menopause challenges. ^{2 3 4 6 7}

Who Is on the Research Team?

Jennifer Duffecy, PhD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

Inclusion Criteria

) by 66% of women If you experience hot flashes or night sweats that are problematic (average score of 2 or higher on three items of the Hot Flush Rating Scale), then 66% of women will experience the same thing.

The person has an elevated score on at least one measure of depression, sleep, or anxiety.

You have an Apple device able to run the Caria app.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use the Caria app for menopause symptom management, including education, goal setting, and cognitive behavioral techniques

6 weeks

Self-report assessments at baseline, 3 weeks, and 6 weeks

Follow-up

Participants are monitored for changes in menopause symptoms and quality of life after app usage

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Caria app
• Menopause Education

How Is the Trial Designed?

Group I: Caria app Experimental Treatment 1 Intervention

The Caria app is publically available on the Apple app store. It is an interactive native app that provides education on menopause as well as symptom tracking/feedback features, social support as well as cognitive behavioral and relaxation techniques. Participants will be given an "unlocked" version with all content available at no charge. The app sends out occasional automated emails to users to remind of features of the app and to encourage them to return to the app. Users can opt out of reminder features.

Group II: Menopause education Active Control 1 Intervention

Participants will receive educational material about menopause from the North American Menopause Society, a well respected menopause organization.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Chorus Health

Collaborator

Trials

1

Recruited

150+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12187029/

Evaluating a Mobile Digital Therapeutic for Vasomotor and ... We evaluated whether a novel digital care app, Caria, effectively reduced vasomotor and behavioral health symptoms of menopause.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10542256/

A systematic review of menopause apps with an emphasis ... The Caria: Menopause & Midlife app and the Ask Early Menopause app both scored the highest on this dimension (mean scores of 3.9). Similarly, ...

3. sciencedirect.com sciencedirect.com/org/science/article/pii/S1929074825006857

Evaluating the Efficacy of a Mobile Phone App in ... A recent randomized controlled trial evaluated the efficacy of Caria, an mHealth app ... menopause symptoms, linked to survey data. Assesses treatment patterns ...

4. withpower.com withpower.com/trial/phase-hot-flashes-9-2021-da04f

Caria: Digital Intervention for Menopause Symptom This trial tests a mobile app aimed at helping women manage menopause symptoms. The app uses education, goal setting, motivation, social support, ...

5. apple.com apple.com/newsroom/2021/03/caria-app-helps-debunk-the-myths-of-menopause/

Caria app helps debunk the myths of menopause From current user surveys, 85 percent of women report improvement in symptoms after using Caria.

6. hellocaria.ai hellocaria.ai/

Caria: Menopause Care, Reimagined Caria is the smartest solution for menopause. Use Caria to understand your changes, manage your symptoms, and join a supportive community.

7. bmcwomenshealth.biomedcentral.com bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-023-02612-9/tables/4

A systematic review of menopause apps with an emphasis on ... Caria is designed to track and manage menopause symptoms, get personalized ... MegsMenopause app is an everything-in-one menopause safe space app jam-packed with ...