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

NCT ID: NCT03109145

Last Updated: 2021-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

859 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2020-01-31

Brief Summary

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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.

Detailed Description

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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

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Menopause

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Menopause educational secure messaging

Secure messages that provide information about menopause and treatment option for menopause symptoms.

Group Type EXPERIMENTAL

Menopause educational secure messaging

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Miami VA Healthcare System

FED

Sponsor Role lead

Responsible Party

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Stuti Dang

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stuti Dang, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Miami VA Healthcare System

Locations

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Miami Veterans Affairs Healthcare System

Miami, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33786517 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31390282 (View on PubMed)

Other Identifiers

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15911255

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pfizer-MEANS

Identifier Type: -

Identifier Source: org_study_id

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