NCT02953262

Brief Summary

Patient-facing eHealth technologies, such as online patient portals, connect patients with the healthcare system, help them access their health information, and support self-management of health conditions. This study tested an intervention to improve adoption and use of the My HealtheVet patient portal for diabetes management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
275

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

October 31, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
2.7 years until next milestone

Study Start

First participant enrolled

July 22, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
10 months until next milestone

Results Posted

Study results publicly available

July 23, 2021

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

12 months

First QC Date

October 31, 2016

Results QC Date

July 2, 2021

Last Update Submit

July 19, 2023

Conditions

Keywords

Diabetes MellitusPersonal Health RecordsPatient Outcome AssessmentMental Health

Outcome Measures

Primary Outcomes (1)

  • Any My HealtheVet Patient Portal Use

    This measure captures any use of MHV within 180 days of the brochure mailing, including use of prescription refills, secure messaging, Blue Button, or any other portal features.

    Portal use within 180 days of initial brochure mailing

Secondary Outcomes (3)

  • Patient Upgraded to a Premium My HealtheVet Portal Account

    180 days from brochure mailing

  • Use of Online Prescription Refills

    180 days from brochure mailing

  • Use of Secure Messaging

    180 days from brochure mailing

Study Arms (4)

Encouragement Arm 1

EXPERIMENTAL

Participants in this encouragement condition will receive a mailed brochure with basic My HealtheVet content and a training guide with (a) insights from other Veterans on how to use My HealtheVet for diabetes self-management, (b) step-by-step guidance for how to sign up for My HealtheVet and, (c) detailed guidance on how to learn to use key features.

Behavioral: My HealtheVet BrochureBehavioral: My HealtheVet Training Guide for Veterans Living with DiabetesBehavioral: My HealtheVet Group TrainingBehavioral: My HealtheVet Individual Training

Encouragement Arm 2

EXPERIMENTAL

Participants in this encouragement condition will receive the same brochure and training guide as Arm 1 but will also be offered optional attendance at one of several group training sessions.

Behavioral: My HealtheVet BrochureBehavioral: My HealtheVet Training Guide for Veterans Living with DiabetesBehavioral: My HealtheVet Group Training

Encouragement Arm 3

EXPERIMENTAL

Participants in this encouragement condition will receive the same as in Arm 2 (brochure, training guide, and group training offer) but will also be offered a one-on-one My HealtheVet training session.

Behavioral: My HealtheVet Training Guide for Veterans Living with DiabetesBehavioral: My HealtheVet Group Training

Brochure Only Comparison Arm

OTHER

The Comparison condition will only receive a mailed brochure with basic My HealtheVet content during the trial. (The training guide will be mailed to them after completion of the interview at the end.)

Behavioral: My HealtheVet Group Training

Interventions

Participants will receive a mailed brochure with basic My HealtheVet content.

Encouragement Arm 1Encouragement Arm 2

Participants will be mailed a bound My HealtheVet training guide with step by step instructions on how to register, upgrade to Premium account, refill prescriptions, use secure messaging, download their Blue Button reports, and other features

Encouragement Arm 1Encouragement Arm 2Encouragement Arm 3

Participants will be invited to participate in a scheduled group training to learn how to use My HealtheVet to help manage their diabetes

Brochure Only Comparison ArmEncouragement Arm 1Encouragement Arm 2Encouragement Arm 3

Participants will be invited to participate in a one-on-one training to learn how to use My HealtheVet to help manage their diabetes at a time of their convenience.

Encouragement Arm 1

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans
  • Hemoglobin A1c result \>=8.5% at most recent lab test prior to recruitment
  • Non use of the VA patient portal, defined by not being registered or registered with no activity in 12 months
  • Currently being seen at one of the sites participating in the study (upcoming appointment scheduled)

You may not qualify if:

  • Non-Veterans
  • Controlled hemoglobin A1c levels (A1c\<8.5%) at most recent lab test prior to recruitment
  • Recent use of the patient portal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730-1114, United States

Location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

Location

Related Publications (4)

  • Robinson SA, Zocchi MS, Netherton D, Ash A, Purington CM, Connolly SL, Vimalananda VG, Hogan TP, Shimada SL. Secure Messaging, Diabetes Self-management, and the Importance of Patient Autonomy: a Mixed Methods Study. J Gen Intern Med. 2020 Oct;35(10):2955-2962. doi: 10.1007/s11606-020-05834-x. Epub 2020 May 21.

  • Stewart MT, Hogan TP, Nicklas J, Robinson SA, Purington CM, Miller CJ, Vimalananda VG, Connolly SL, Wolfe HL, Nazi KM, Netherton D, Shimada SL. The Promise of Patient Portals for Individuals Living With Chronic Illness: Qualitative Study Identifying Pathways of Patient Engagement. J Med Internet Res. 2020 Jul 17;22(7):e17744. doi: 10.2196/17744.

  • Zocchi MS, Robinson SA, Ash AS, Vimalananda VG, Wolfe HL, Hogan TP, Connolly SL, Stewart MT, Am L, Netherton D, Shimada SL. Patient portal engagement and diabetes management among new portal users in the Veterans Health Administration. J Am Med Inform Assoc. 2021 Sep 18;28(10):2176-2183. doi: 10.1093/jamia/ocab115.

  • Robinson SA, Netherton D, Zocchi M, Purington C, Ash AS, Shimada SL. Differences in Secure Messaging, Self-management, and Glycemic Control Between Rural and Urban Patients: Secondary Data Analysis. JMIR Diabetes. 2021 Nov 19;6(4):e32320. doi: 10.2196/32320.

MeSH Terms

Conditions

Diabetes MellitusPsychological Well-Being

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPersonal SatisfactionBehavior

Limitations and Caveats

Due to the COVID-19 pandemic, group and one-on-one sessions planned at the second site had to be converted to virtual sessions without a hands-on component. This led to lower participation in training sessions at this second site. At the second site, 15 people who had portal activity in the previous year were inadvertently included. These 15 people were excluded from analysis of outcomes. Only a subset of those enrolled in each arm completed the telephone interview.

Results Point of Contact

Title
Stephanie Shimada, PhD
Organization
Center for Healthcare Organization and Implementation Research (CHOIR) United States Department of Veterans Affairs VA Bedford Healthcare System

Study Officials

  • Stephanie L Shimada, PhD

    VA Bedford HealthCare System, Bedford, MA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were not explicitly told which group they were randomized to
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 2, 2016

Study Start

July 22, 2019

Primary Completion

July 5, 2020

Study Completion

September 30, 2020

Last Updated

July 28, 2023

Results First Posted

July 23, 2021

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations