Caria: Digital Intervention for Menopause Symptom

Study Overview
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Brief Summary
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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.

Official Title
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Caria: Digital Intervention for Menopause Symptom

Conditions
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Menopause, Hot Flashes

Intervention / Treatment
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* Behavioral: Caria app
* Behavioral: Menopause Education


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caria app<br>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<br>* App to improve symptoms of menopause<br>|
| Active Comparator: Menopause education<br>Participants will receive educational material about menopause from the North American Menopause Society, a well respected menopause organization. | Behavioral: Menopause Education<br>* Educational materials about symptoms of menopause<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Women's Health Questionnaire | The Women's Health Questionnaire (WHQ) is a measure of mid-aged women's emotional and physical health. | 6 weeks |