Menopause, Postmenopause, Premenopause
Conditions
Keywords
Computer-Assisted Decision Making, Internet-Based Intervention
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: 1. 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). 2. 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.
Interventions
OTHERMyMenoPlan
Participants are asked to spend at least 20 minutes on the website (MyMenoPlan) assigned to them.
OTHERControl
Participants are asked to spend at least 20 minutes on at least one of the following websites: 1. North American Menopause Society: https://www.menopause.org/for-women 2. National Institute on Aging: https://www.nia.nih.gov/health/topics/menopause 3. The Office on Women's Health-Menopause: https://www.womenshealth.gov/menopause
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* As stated above
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Quality of Information | 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. |
| Readability | 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. |
| Self-Efficacy for Managing Menopause Symptoms | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
Eligibility screening and quality control checks resulted in exclusion of 503. Internet recruited studies requires careful quality control checks for fraudulent participants.
Participants by arm
| Arm | Count |
|---|---|
| MyMenoPlan Participants are asked to spend at least 20 minutes on the website (MyMenoPlan) assigned to them.
MyMenoPlan: Participants are asked to spend at least 20 minutes on the website (MyMenoPlan) assigned to them. | 200 |
| Control Participants are asked to spend at least 20 minutes on at least one of the following websites or other websites of their choice:
1. North American Menopause Society: https://www.menopause.org/for-women
2. National Institute on Aging: https://www.nia.nih.gov/health/topics/menopause
3. The Office on Women's Health-Menopause: https://www.womenshealth.gov/menopause
Control: Participants are asked to spend at least 20 minutes on at least one of the following websites:
1. North American Menopause Society: https://www.menopause.org/for-women
2. National Institute on Aging: https://www.nia.nih.gov/health/topics/menopause
3. The Office on Women's Health-Menopause: https://www.womenshealth.gov/menopause | 210 |
| Total | 410 |
Baseline characteristics
| Characteristic | MyMenoPlan | Control | Total |
|---|---|---|---|
| Age, Continuous | 49.1 years STANDARD_DEVIATION 4 | 49.4 years STANDARD_DEVIATION 3.8 | 49.3 years STANDARD_DEVIATION 3.91 |
| Difficulty paying for basics A lot | 30 Participants | 31 Participants | 61 Participants |
| Difficulty paying for basics None | 105 Participants | 93 Participants | 198 Participants |
| Difficulty paying for basics Some | 63 Participants | 83 Participants | 146 Participants |
| Difficulty paying for basics Unknown | 2 Participants | 3 Participants | 5 Participants |
| Education College graduate | 46 Participants | 42 Participants | 88 Participants |
| Education High school or less | 23 Participants | 42 Participants | 65 Participants |
| Education Post-graduate degree | 50 Participants | 37 Participants | 87 Participants |
| Education Some college or vocational training | 81 Participants | 87 Participants | 168 Participants |
| Education Unknown | 0 Participants | 2 Participants | 2 Participants |
| Education (years) | 15.2 years STANDARD_DEVIATION 2.3 | 14.7 years STANDARD_DEVIATION 2.3 | 14.96 years STANDARD_DEVIATION 2.29 |
| Menopause Stage Don't know - hysterectomy but kept ovaries | 8 Participants | 9 Participants | 17 Participants |
| Menopause Stage Don't know - IUD | 9 Participants | 10 Participants | 19 Participants |
| Menopause Stage Perimenopause | 109 Participants | 102 Participants | 211 Participants |
| Menopause Stage Postmenopause | 54 Participants | 66 Participants | 120 Participants |
| Menopause Stage Premenopause | 18 Participants | 23 Participants | 41 Participants |
| Menopause Stage Unknown | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 6 Participants | 8 Participants |
| Race/Ethnicity, Customized Black | 18 Participants | 28 Participants | 46 Participants |
| Race/Ethnicity, Customized Hispanic | 9 Participants | 8 Participants | 17 Participants |
| Race/Ethnicity, Customized Multiethnic | 12 Participants | 9 Participants | 21 Participants |
| Race/Ethnicity, Customized Native American, Native Hawaiian, Pacific Islander | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Unknown/not reported | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 153 Participants | 154 Participants | 307 Participants |
| Sex: Female, Male Female | 200 Participants | 210 Participants | 410 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 200 | 0 / 210 |
| other Total, other adverse events | 0 / 200 | 0 / 210 |
| serious Total, serious adverse events | 0 / 200 | 0 / 210 |
Outcome results
Primary
Credibility
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.
Time frame: Each survey question is answered after spending at least 20 minutes on the assigned website(s)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MyMenoPlan | Credibility | 4.3 score on a scale | Standard Deviation 0.66 |
| Control | Credibility | 4.4 score on a scale | Standard Deviation 0.65 |
p-value: 0.45Chi-squared
Primary
Perceived Quality of Information
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.
Time frame: Each survey question is answered after spending at least 20 minutes on the assigned website(s)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MyMenoPlan | Perceived Quality of Information | 4.1 score on a scale | Standard Deviation 0.59 |
| Control | Perceived Quality of Information | 3.7 score on a scale | Standard Deviation 0.73 |
p-value: <0.001Chi-squared
Primary
Readability
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.
Time frame: Each survey question is answered after spending at least 20 minutes on the assigned website(s)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MyMenoPlan | Readability | 4.6 score on a scale | Standard Deviation 0.52 |
| Control | Readability | 4.4 score on a scale | Standard Deviation 0.67 |
p-value: 0.02Chi-squared
Primary
Self-Efficacy for Managing Menopause Symptoms
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.
Time frame: Each survey question is answered after spending at least 20 minutes on the assigned website(s)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MyMenoPlan | Self-Efficacy for Managing Menopause Symptoms | 4.0 score on a scale | Standard Deviation 0.66 |
| Control | Self-Efficacy for Managing Menopause Symptoms | 3.9 score on a scale | Standard Deviation 0.71 |
p-value: 0.22Chi-squared