NCT04882982

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

May 6, 2021

Last Update Submit

November 27, 2023

Conditions

MenopauseHot Flashes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Women's Health Questionnaire

    6 weeks

Study Arms (2)

Caria app

EXPERIMENTAL

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.

Behavioral: Caria app

Menopause education

ACTIVE COMPARATOR

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

Behavioral: Menopause Education

Interventions

Caria appBEHAVIORAL

App to improve symptoms of menopause

Caria app
Menopause EducationBEHAVIORAL

Educational materials about symptoms of menopause

Menopause education

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants need to be experiencing menopause or the menopausal transition.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer Duffecy, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 6, 2021

First Posted

May 12, 2021

Study Start

February 1, 2022

Primary Completion

October 15, 2022

Study Completion

December 15, 2022

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)