Caria: Digital Intervention for Menopause Symptom

NCT ID: NCT04882982

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-12-15

Brief Summary

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Menopause is the time of life when menstrual cycles cease. Women typically spend 30-40% of their lives in menopause. Individual experiences of menopause vary and although some women do not experience any significant symptoms, common symptoms include vasomotor dysfunction, vaginal dryness, mood changes, sleep disturbances, urinary incontinence, cognitive changes, somatic complaints and sexual dysfunction. Reduced quality of life can occur as a result of these symptoms. A mobile app has been developed to reduce the impact of these symptoms using a variety of behavioral change techniques including education, goal setting, motivational enhancement, social support and cognitive behavioral approaches. Participants will complete self report assessments of women's symptoms and QOL at baseline, 3 weeks and 6 weeks of app use.

Detailed Description

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Conditions

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Menopause Hot Flashes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Caria app

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 Type EXPERIMENTAL

Caria app

Intervention Type BEHAVIORAL

App to improve symptoms of menopause

Menopause education

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

Group Type ACTIVE_COMPARATOR

Menopause Education

Intervention Type BEHAVIORAL

Educational materials about symptoms of menopause

Interventions

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Caria app

App to improve symptoms of menopause

Intervention Type BEHAVIORAL

Menopause Education

Educational materials about symptoms of menopause

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

\- Women with variable menstrual cycles (menopausal transition) or those who were more than 1 year from their last menstrual period (postmenopause)

Hot flash/night sweats should be experienced as problematic (as indicated by an average score of 2 or higher on three items of the Hot Flush Rating Scale

Elevated score on at least one measure - either depression (PHQ8=10 or greater, sleep (PSQI of 5 or greater) or anxiety (GAD7=10 or greater)

Own an apple device able to run the Caria app

English speaking

Exclusion Criteria

* None
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chorus Health

UNKNOWN

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Duffecy

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Duffecy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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2021-0282

Identifier Type: -

Identifier Source: org_study_id