Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02953262
Other study ID # IIR 15-307
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 22, 2019
Est. completion date September 30, 2020

Study information

Verified date July 2023
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The goal of this small scale study is to test the feasibility of engaging Veterans in a supported adoption intervention to promote effective patient portal use in a sample of Veterans with uncontrolled Type II diabetes. Participants were eligible for recruitment if they were Veterans age 18-85 who were actively receiving care at one of the study sites (as determined by having an upcoming scheduled appointment), had uncontrolled glucose (HbA1c >= 8.5%), and had either never used the VA patient portal or were inactive registrants who have not used the patient portal in the past 12 months. Participants who met these conditions and did not opt out of the study were randomized to one of four arms: 1) Encouragement I (brochure + mailed training guide), 2) Encouragement II (brochure + mailed training guide + invitation to group training), 3) Encouragement III (brochure + mailed training guide + invitation to group and one-on-one training), and 4) Comparison (standard patient portal enrollment brochure only). All arms received the standard My HealtheVet patient portal enrollment brochure along with an invitation to participate in the study. Those randomized to any of the Encouragement Arms received a mailed training guide. The My HealtheVet Training Guide for Veterans Living with Diabetes was designed in conjunction with Veteran co-investigators based on feedback from patients living with diabetes who were My HealtheVet users. It provided step by step guidance on how to use the features Veterans living with diabetes find most helpful with specific examples of use for diabetes self-management. Those in Encouragement Arm II were also invited to attend one of several group training sessions. Those in Encouragement III were invited to schedule a one-on one session to learn how to use the patient portal. Those in the comparison condition were asked during their interview if they would like a Training Guide mailed to them at the end of the trial, and those interested were mailed a Training Guide.


Recruitment information / eligibility

Status Completed
Enrollment 275
Est. completion date September 30, 2020
Est. primary completion date July 5, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - 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) Exclusion Criteria: - Non-Veterans - Controlled hemoglobin A1c levels (A1c<8.5%) at most recent lab test prior to recruitment - Recent use of the patient portal

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
My HealtheVet Brochure
Participants will receive a mailed brochure with basic My HealtheVet content.
My HealtheVet Training Guide for Veterans Living with Diabetes
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
My HealtheVet Group Training
Participants will be invited to participate in a scheduled group training to learn how to use My HealtheVet to help manage their diabetes
My HealtheVet Individual Training
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.

Locations

Country Name City State
United States VA Bedford HealthCare System, Bedford, MA Bedford Massachusetts
United States VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (4)

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: 10.2196/323 — View Citation

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- — View Citation

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 Pathw — View Citation

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 Ass — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Patient Upgraded to a Premium My HealtheVet Portal Account After registering for the portal, patients must confirm their identity and accept the terms and conditions of the portal in order to upgrade to Premium status which allows access to secure messaging, their VA appointments, and electronic health record extracts such as lab results, medical imaging and reports, clinical notes, and their VA health summary. Patients can access a limited subset of portal features, including online prescription refills, without upgrading to Premium. This measure captures whether a participant upgraded to a Premium account during the trial. 180 days from brochure mailing
Secondary Use of Online Prescription Refills This measure captures whether the participant used the portal's online prescription refill feature at least once within 180 days of mailing the brochure. 180 days from brochure mailing
Secondary Use of Secure Messaging Patient used the secure messaging feature during the trial 180 days from brochure mailing
See also
  Status Clinical Trial Phase
Completed NCT03743779 - Mastering Diabetes Pilot Study
Completed NCT03786978 - Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus N/A
Completed NCT01804803 - DIgital Assisted MONitoring for DiabeteS - I N/A
Completed NCT05039970 - A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT04068272 - Safety of Bosentan in Type II Diabetic Patients Phase 1
Completed NCT03243383 - Readmission Prevention Pilot Trial in Diabetes Patients N/A
Completed NCT03730480 - User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS) N/A
Recruiting NCT02690467 - Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm. N/A
Completed NCT02229383 - Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus Phase 3
Completed NCT06181721 - Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes N/A
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Recruiting NCT04489043 - Exercise, Prediabetes and Diabetes After Renal Transplantation. N/A
Withdrawn NCT03319784 - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients Phase 4
Completed NCT03542084 - Endocrinology Auto-Triggered e-Consults N/A
Completed NCT02229396 - Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo Phase 3
Recruiting NCT05544266 - Rare and Atypical Diabetes Network
Completed NCT01892319 - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Completed NCT05031000 - Blood Glucose Monitoring Systems: Discounter Versus Brand N/A
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A