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

April 12, 2021 updated by: Stuti Dang, Miami VA Healthcare System

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

859

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33125
        • Miami Veterans Affairs Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Menopause educational secure messaging
Secure messages that provide information about menopause and treatment option for menopause symptoms.
Other: Menopause educational secure messaging
Participants read educational material about menopause and treatment option for menopause symptoms once a week using secure messaging on a electronic patient portal.
No Intervention: Usual care: Control
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%)
6-months
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.
6-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shared decision making
Time Frame: Through study completion, an average of 3-years
Self-reported rate of shared decision making among women veteran and their providers.
Through study completion, an average of 3-years
Menopause related diagnosis
Time Frame: Through study completion, an average of 3-years
Rates of diagnosis and appropriate management of menopause related symptoms and use of hormone therapy.
Through study completion, an average of 3-years
Focus Group
Time Frame: 6-months
Qualitative assessment of the interventions through participant semi-structure focus group interviews.
6-months
Patient portal registration and authentication
Time Frame: Through study completion, an average of 3-years
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.
Through study completion, an average of 3-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Miami VA Healthcare System

Collaborators

Pfizer

Investigators

  • Principal Investigator: Stuti Dang, MD, MPH, Miami VA Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

December 12, 2016

First Submitted That Met QC Criteria

April 5, 2017

First Posted (Actual)

April 12, 2017

Study Record Updates

Last Update Posted (Actual)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 12, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pfizer-MEANS
  • 15911255 (Other Grant/Funding Number: Pfizer)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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