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Caria: Digital Intervention for Menopause Symptom

Primary Purpose

Menopause, Hot Flashes

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caria app
Menopause Education
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menopause

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Illinois at Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Caria app

Menopause education

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
May 6, 2021
Last Updated
November 1, 2022
Sponsor
University of Illinois at Chicago
Collaborators
Chorus Health
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1. Study Identification

Unique Protocol Identification Number
NCT04882982
Brief Title
Caria: Digital Intervention for Menopause Symptom
Official Title
Caria: Digital Intervention for Menopause Symptom
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
October 15, 2022 (Actual)
Study Completion Date
December 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
Chorus Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause, Hot Flashes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caria app
Arm Type
Experimental
Arm Description
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.
Arm Title
Menopause education
Arm Type
Active Comparator
Arm Description
Participants will receive educational material about menopause from the North American Menopause Society, a well respected menopause organization.
Intervention Type
Behavioral
Intervention Name(s)
Caria app
Intervention Description
App to improve symptoms of menopause
Intervention Type
Behavioral
Intervention Name(s)
Menopause Education
Intervention Description
Educational materials about symptoms of menopause
Primary Outcome Measure Information:
Title
Hot Flush Rating Scale
Description
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).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Women's Health Questionnaire
Description
The Women's Health Questionnaire (WHQ) is a measure of mid-aged women's emotional and physical health.
Time Frame
6 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants need to be experiencing menopause or the menopausal transition.
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Duffecy, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Caria: Digital Intervention for Menopause Symptom

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