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

NCT03109145

Last updated date
Study Location
Miami Veterans Affairs Healthcare System
Miami, Florida, 33125, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Menopause
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Not willing to register and become authenticated for patient health portal.


- Not willing to receive educational secure messages from patient health portal.

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MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE MyHealtheVet to Enable Shared Decision Making Regarding Menopausal in Postmenopausal Women Veterans (MEANS)
Official Title  ICMJE MyHealtheVet to Enable Shared Decision Making Regarding Menopausal and Associated Symptoms in Postmenopausal Women Veterans
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Menopause
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Menopause educational secure messaging
    Secure messages that provide information about menopause and treatment option for menopause symptoms.
    Intervention: Other: Menopause educational secure messaging
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2021)
859
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2017)
400
Actual Study Completion Date  ICMJE January 31, 2020
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 45 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03109145
Other Study ID Numbers  ICMJE Pfizer-MEANS
15911255 ( Other Grant/Funding Number: Pfizer )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Stuti Dang, Miami VA Healthcare System
Study Sponsor  ICMJE Miami VA Healthcare System
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Stuti Dang, MD, MPHMiami VA Healthcare System
PRS Account Miami VA Healthcare System
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP