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Completed

NCT Number: NCT03109145

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

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.

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Key information

Conditions

Menopause

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Miami Veterans Affairs Healthcare System

Miami, Florida, 33125, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Menopause educational secure messaging

Other

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

Primary outcomes

  1. 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%)

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Focus Group

    Time frame: 6-months

    Qualitative assessment of the interventions through participant semi-structure focus group interviews.

  4. 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.

Sponsors and collaborators

Lead sponsor

Miami VA Healthcare System

Fed

Collaborators

  • Pfizer

Registry information

Official study title

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

Acronym: MEANS

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Apr 12, 2017
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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