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OpenTrials
Completed

NCT Number: NCT04882982

Caria: Digital Intervention for Menopause Symptom

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.

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Key information

Conditions

Menopause Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caria app

Behavioral

App to improve symptoms of menopause

Menopause Education

Behavioral

Educational materials about symptoms of menopause

Primary outcomes

  1. Hot Flush Rating Scale

    Time frame: 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 outcomes

  1. Women's Health Questionnaire

    Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • Chorus Health

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 12, 2021
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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