MenopauseMEANSNCT03109145

MyHealtheVet to Enable Shared Decision Making Regarding Menopausal in Postmenopausal Women Veterans (MEANS)

A study testing Menopause educational secure messaging in people with Menopause, run by Miami VA Healthcare System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this research study is to examine the impact of educational secure messages on menopause. In particular, the investigators will examine whether the secure messages increase menopause knowledge and communication between patients and their providers. Read more about this study

Who is it for?: Ages 45 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Menopause
What is being tested?: Menopause educational secure messaging
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 859 participants
Where: 1 siteUnited States
Study dates: Oct 2014to 31 Jan 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 60 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Women Veterans, age 45-60
Receive primary care at the Miami Veterans Affairs Healthcare System
Able to communicate in English
Already or willing to register and become authenticated in the patient health portal, MyHealtheVet.
Able to use read, understand, and respond to secure messages using patient health portal.

Who cannot join

Not willing to register and become authenticated for patient health portal.
Not willing to receive educational secure messages from patient health portal.

Trial locations and contacts

1 site in 1 country.

United States1 site

Miami Veterans Affairs Healthcare System
Miami, Florida, 33125

Other trials in United States

About this study

Official title: MyHealtheVet to Enable Shared Decision Making Regarding Menopausal and Associated Symptoms in Postmenopausal Women Veterans

Read the detailed description

The overall goal of this project is to determine the effectiveness of the MEANS (MyHealtheVet to Enable And Negotiate for Shared decision making) intervention in improving women's self-reported knowledge and rates of diagnosis and appropriate management of menopause symptoms. The proposed intervention is an educational and shared decision making platform for menopause symptoms to improve communication between patients and their providers regarding menopause symptoms. MEANS combines educational secure messages through the Veterans Affairs online Personal Health Record called MyHealtheVet, along with face-to-face and print interventions.

MEANS will be applied in target population consisting of postmenopausal women Veterans ages 45 to 60 who receive primary care at the Miami Veterans Affairs Healthcare System. This project will enroll women in MyHealtheVet, develop a library of menopause symptoms material for distribution, and evaluate how useful of MyHealtheVet use for educating and tracking women regarding menopause symptoms.

Conditions: Menopause
Being tested: Menopause educational secure messaging
Keywords: Shared decision making, Knowledge, Patient portal, Secure messaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Menopause educational secure messagingOther
Participants read educational material about menopause and treatment option for menopause symptoms once a week using secure messaging on a electronic patient portal.

Study groups in NCT03109145
Study group	Role	What they receive
Menopause educational secure messaging	Experimental	Secure messages that provide information about menopause and treatment option for menopause symptoms. Receives: Other: Menopause educational secure messaging
Usual care: Control	No intervention	Control group of eligible women patients between 45-60 years who do not receive the intervention at the West Palm Beach and Orlando Veterans Healthcare System. Usual care participants did not receive the educational secure messages.

What is being measured

The primary outcome is the main question the study is designed to answer.

Menopause Knowledge
Total menopause knowledge score (a) before and after the intervention, an average of 6-months and (b) compared to a control group of eligible women patients between 45-60 years who do not receive the intervention at the West Palm Beach and Orlando Veterans Healthcare System. Score is the percent of knowledge questions answered correctly (0 - 100%)
Measured: 6-months
Feasibility of patient portal use for educating and tracking women regarding menopause and menopause related symptoms.
The study will send weekly secure messages regarding menopause, and ask participants to report their menopause related symptoms by secure messaging. The research study will track the number of times participants read the weekly information sent via MyHealtheVet and the proportion of times they respond.
Measured: 6-months

Secondary outcomes (4)

Shared decision making
Self-reported rate of shared decision making among women veteran and their providers.
Measured: Through study completion, an average of 3-years
Menopause related diagnosis
Rates of diagnosis and appropriate management of menopause related symptoms and use of hormone therapy.
Measured: Through study completion, an average of 3-years
Focus Group
Qualitative assessment of the interventions through participant semi-structure focus group interviews.
Measured: 6-months
Patient portal registration and authentication
Measure the number of eligible women patients in the Miami Veterans Healthcare System who are enrolled and authenticated in the patient portal before and after the intervention.
Measured: Through study completion, an average of 3-years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 201431 Jan 2020

First posted12 Apr 2017
Study startOct 2014
Primary completion31 Jan 2020
Study completion31 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for MenopauseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 859 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03109145
Sponsor's protocol ID: Pfizer-MEANS
Other IDs: 15911255
Acronym: MEANS
Status last verified: Apr 2021
First submitted: 12 Dec 2016
Last updated: 13 Apr 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lamba AH, Muralidhar K, Jain A, Tang F, Gomez-Marin O, Levis S, Dang S. Characteristics of Women Enrolled in a Patient Portal Intervention for Menopause. Womens Health Rep (New Rochelle). 2020 Oct 26;1(1):500-510. doi: 10.1089/whr.2020.0091. eCollection 2020.
PubMed 33786517
Dang S, Thavalathil B, Ruiz D, Gomez-Orozco C, Gomez-Marin O, Levis S. A Patient Portal Intervention for Menopause Knowledge and Shared Decision-Making. J Womens Health (Larchmt). 2019 Dec;28(12):1614-1622. doi: 10.1089/jwh.2018.7461. Epub 2019 Aug 7.
PubMed 31390282

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Menopause trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MyHealtheVet to Enable Shared Decision Making Regarding Menopausal and Associated Symptoms in Postmenopausal Women Veterans
ClinicalTrials.gov ID: NCT03109145
Acronym / sponsor ID: MEANS / Pfizer-MEANS
Conditions: Menopause
Keywords: Shared decision making, Knowledge, Patient portal, Secure messaging
Study type: Interventional
Recruitment status: Completed
Enrolment: 859 participants (actual)
Lead sponsor: Miami VA Healthcare SystemUS federal agency
Collaborators: Pfizer
Study start: Oct 2014
Primary completion: 31 Jan 2020 (actual)
Study completion: 31 Jan 2020 (actual)
First posted: 12 Apr 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Menopause educational secure messaging	Experimental	Other: Menopause educational secure messagingSecure messages that provide information about menopause and treatment option for menopause symptoms.
Usual care: Control	No intervention	–Control group of eligible women patients between 45-60 years who do not receive the intervention at the West Palm Beach and Orlando Veterans Healthcare System. Usual care participants did not receive the educational secure messages.

Who may qualify

Ages: 45 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Women Veterans, age 45-60
Receive primary care at the Miami Veterans Affairs Healthcare System
Able to communicate in English
Already or willing to register and become authenticated in the patient health portal, MyHealtheVet.
Able to use read, understand, and respond to secure messages using patient health portal.

Key exclusion criteria (2 listed)

Not willing to register and become authenticated for patient health portal.
Not willing to receive educational secure messages from patient health portal.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Menopause educational secure messagingParticipants read educational material about menopause and treatment option for menopause symptoms once a week using secure messaging on a electronic patient portal.	Other	Menopause educational secure messaging

Primary outcome

Menopause Knowledge
Time frame: 6-months
Total menopause knowledge score (a) before and after the intervention, an average of 6-months and (b) compared to a control group of eligible women patients between 45-60 years who do not receive the intervention at the West Palm Beach and Orlando Veterans Healthcare System. Score is the percent of knowledge questions answered correctly (0 - 100%)
Feasibility of patient portal use for educating and tracking women regarding menopause and menopause related symptoms.
Time frame: 6-months
The study will send weekly secure messages regarding menopause, and ask participants to report their menopause related symptoms by secure messaging. The research study will track the number of times participants read the weekly information sent via MyHealtheVet and the proportion of times they respond.

4 secondary outcomes

Shared decision making
Time frame: Through study completion, an average of 3-years
Menopause related diagnosis
Time frame: Through study completion, an average of 3-years
Focus Group
Time frame: 6-months
Patient portal registration and authentication
Time frame: Through study completion, an average of 3-years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
Derived from this study: PubMed 33786517Lamba AH, Muralidhar K, Jain A, Tang F, Gomez-Marin O, Levis S, Dang S. Characteristics of Women Enrolled in a Patient Portal Intervention for Menopause. Womens Health Rep (New Rochelle). 2020 Oct 26;1(1):500-510. doi: 10.1089/whr.2020.0091. eCollection 2020.
Derived from this study: PubMed 31390282Dang S, Thavalathil B, Ruiz D, Gomez-Orozco C, Gomez-Marin O, Levis S. A Patient Portal Intervention for Menopause Knowledge and Shared Decision-Making. J Womens Health (Larchmt). 2019 Dec;28(12):1614-1622. doi: 10.1089/jwh.2018.7461. Epub 2019 Aug 7.
Individual participant dataSharing planned: No

Related trials for Menopause

Not yet recruitingPhase 3
SYNCHRONIZE®-HERA: A Study to Test Whether Survodutide Helps Women Who Are Living With Overweight or Obesity and Are Going Through or Have Finished Menopause, to Lose Weight
Obesity
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
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Recruiting
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Not yet recruiting
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Menopause, Perimenopause

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stuti Dang, MD, MPH principal investigator

Miami VA Healthcare System

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Menopause educational secure messaging in people with Menopause, run by Miami VA Healthcare System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Menopause Knowledge (time frame: 6-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03109145, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.