MsFLASH: Living a Healthy Menopause, Aim 2 Randomized Controlled Trial of MyMenoPlan
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 410
- Locations
- 1
- Primary Endpoint
- Self-Efficacy for Managing Menopause Symptoms
Study Overview
Brief Summary
As part of a National Institute on Aging -funded R01, the investigators developed an evidence-based, multi-media digital resource entitled MyMenoPlan to help women learn about the menopause transition, and the symptoms and treatments of perimenopause/menopause. MyMenoPlan is also designed to help women learn about the effectiveness of treatments for a comprehensive list of midlife symptoms and compare treatments that may help with the specific symptoms women are experiencing.
Detailed Description
The purpose of this research study is to:
- Investigate how women randomly assigned to visit MyMenoPlan use the website (time spent on website, treatment and symptom page views, use of interactive tools, and use of the MyMenoPlan tool).
- Compare the ratings of women randomly assigned to MyMenoPlan to those randomly assigned to other menopause websites for perceived quality of information, readability, self-efficacy, and credibility of these online menopause resources.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •As stated above
Exclusion Criteria
- Not provided
Arms & Interventions
MyMenoPlan
Participants are asked to spend at least 20 minutes on the website (MyMenoPlan) assigned to them.
Intervention: MyMenoPlan (Other)
Control
Participants are asked to spend at least 20 minutes on at least one of the following websites or other websites of their choice:
- North American Menopause Society: https://www.menopause.org/for-women
- National Institute on Aging: https://www.nia.nih.gov/health/topics/menopause
- The Office on Women's Health-Menopause: https://www.womenshealth.gov/menopause
Intervention: Control (Other)
Outcomes
Primary Outcomes
Self-Efficacy for Managing Menopause Symptoms
Time Frame: Each survey question is answered after spending at least 20 minutes on the assigned website(s)
This is a newly developed Likert scale (1- Strongly disagree to 5 - Strongly agree) for assessing participants' beliefs in their own abilities in managing menopausal symptoms. The range of this scale is 1-5. The items in this scale were averaged with a higher score meaning higher on this outcome (self-efficacy). Items: 1. If I want to, I am certain I could figure out the treatments or coping strategies that would work best for me. 2. I feel I could treat or cope with my symptoms of perimenopause/menopause if I want to.
Credibility
Time Frame: Each survey question is answered after spending at least 20 minutes on the assigned website(s)
This 2-item, 5-point Likert (1- Strongly disagree to 5 - Strongly agree) scale was derived from the Standardized User Experience Percentile Rank Questionnaire (SUPR-Q) in Sauro (1995). The range of this scale is 1-5. The items in this scale were averaged with a higher score meaning higher on this outcome (credibility). Items: 1. The information is credible. 2. The information is trustworthy.
Readability
Time Frame: Each survey question is answered after spending at least 20 minutes on the assigned website(s)
This 2-item, 5-point Likert (1- Strongly disagree to 5 - Strongly agree)scale was derived from the Standardized User Experience Percentile Rank Questionnaire (SUPR-Q) in Sauro (1995). The range of this scale is 1-5. The items in this scale were averaged with a higher score meaning higher on this outcome (readability). Items: 1. The information I read was clear. 2. The information I read was easy for me to understand.
Perceived Quality of Information
Time Frame: Each survey question is answered after spending at least 20 minutes on the assigned website(s)
This 7-item, 5-point Likert scale (1- Strongly disagree to 5 - Strongly agree) is adapted from the Post-Study System Usability Questionnaire (PSSUQ) in Lewis (1995). The range of this scale is 1-5. The items in this scale were averaged with a higher score meaning higher on this outcome (perceived quality of information). Items: 1. Reading the information made me feel in more control of my perimenopause/menopause. 2. The information on the website(s) was helpful to me. 3. I found the information I was looking for. 4. The information answered my questions about perimenopause/menopause. 5. I liked the website (s). 6. I would have liked more in-depth information. (reverse-coded) 7. The website(s) were fairly comprehensive about perimenopause /menopause.
Secondary Outcomes
No secondary outcomes reported
Investigators
Andrea Z. LaCroix, PhD
Distinguished Professor of Epidemiology
University of California, San Diego