Caria: Digital Intervention for Menopause Symptom

Not Applicable

Completed

• Conditions: Hot Flashes; Menopause
• Interventions: Behavioral: Caria app; Behavioral: Menopause Education

• Registration Number: NCT04882982
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-12
• Study Start: 2022-02-01
• Primary Completion: 2022-10-15
• Study Completion: 2022-12-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caria app	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.
Menopause education	Menopause Education	Participants will receive educational material about menopause from the North American Menopause Society, a well respected menopause organization.

Primary Outcome Measures

Name	Time	Method
Hot Flush Rating Scale	6 weeks	A measure of self-reported hot flashes, night sweats and/or severity of hot flashes typically using a dairy to record the frequency and severity of hot flashes using a 4-point scale: mild, moderate, severe, very severe to provide a hot flash index (sum of the number of hot flashes multiplied by severity).

Secondary Outcome Measures

Name	Time	Method
Women's Health Questionnaire	6 weeks	The Women's Health Questionnaire (WHQ) is a measure of mid-aged women's emotional and physical health.

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States