NCT03109145

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
859

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

5.3 years

First QC Date

December 12, 2016

Last Update Submit

April 12, 2021

Conditions

Menopause

Keywords

Shared decision makingKnowledgePatient portalSecure messaging

Outcome Measures

Primary Outcomes (2)

  • 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%)

    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.

    6-months

Secondary Outcomes (4)

  • Shared decision making

    Through study completion, an average of 3-years

  • Menopause related diagnosis

    Through study completion, an average of 3-years

  • Focus Group

    6-months

  • Patient portal registration and authentication

    Through study completion, an average of 3-years

Study Arms (2)

Menopause educational secure messaging

EXPERIMENTAL

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

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.

Interventions

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.

Menopause educational secure messaging

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miami Veterans Affairs Healthcare System

Miami, Florida, 33125, United States

Location

Related Publications (2)

  • 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.

    PMID: 33786517DERIVED

  • 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.

    PMID: 31390282DERIVED

Study Officials

  • Stuti Dang, MD, MPH

    Miami VA Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

December 12, 2016

First Posted

April 12, 2017

Study Start

October 1, 2014

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

April 13, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)