Caria: Digital Intervention for Menopause Symptom

Menopause Clinical Trial

Official title:

Caria: Digital Intervention for Menopause Symptom

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04882982
• Other study ID #: 2021-0282
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: November 2023
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 15, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hot Flashes
• Menopause

Intervention

Behavioral:
• Caria app
App to improve symptoms of menopause
• Menopause Education
Educational materials about symptoms of menopause

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Chorus Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hot Flush Rating Scale	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).	6 weeks
Secondary	Women's Health Questionnaire	The Women's Health Questionnaire (WHQ) is a measure of mid-aged women's emotional and physical health.	6 weeks