Diabetes MellitusNCT02953262

Improving Diabetes Care Through Effective Personalized Patient Portal Interactions

A study testing My HealtheVet Brochure, My HealtheVet Training Guide for Veterans Living with Diabetes and My HealtheVet Group Training in people with Diabetes Mellitus, run by VA Office of Research and Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Diabetes Mellitus
What is being tested?: My HealtheVet Brochure, My HealtheVet Training Guide for Veterans Living with Diabetes and My HealtheVet Group Training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 275 participants
Where: 2 sitesUnited States
Study dates: 22 Jul 2019to 30 Sep 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, 01730-1114
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817

Other trials in United States

About this study

Read the detailed 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.

Conditions: Diabetes Mellitus
Being tested: My HealtheVet Brochure, My HealtheVet Training Guide for Veterans Living with Diabetes, My HealtheVet Group Training, My HealtheVet Individual Training
Keywords: Diabetes Mellitus, Personal Health Records, Patient Outcome Assessment, Mental Health
Medical subject headings: Diabetes Mellitus, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

My HealtheVet BrochureBehavioural
Participants will receive a mailed brochure with basic My HealtheVet content.
My HealtheVet Training Guide for Veterans Living with DiabetesBehavioural
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 TrainingBehavioural
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 TrainingBehavioural
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.

Study groups in NCT02953262
Study group	Role	What they receive
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. Receives: Behavioral: My HealtheVet Brochure; Behavioral: My HealtheVet Training Guide for Veterans Living with Diabetes; Behavioral: My HealtheVet Group Training; Behavioral: 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. Receives: Behavioral: My HealtheVet Brochure; Behavioral: My HealtheVet Training Guide for Veterans Living with Diabetes; Behavioral: 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. Receives: Behavioral: My HealtheVet Training Guide for Veterans Living with Diabetes; Behavioral: 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.) Receives: Behavioral: My HealtheVet Group Training

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Portal use within 180 days of initial brochure mailing

Secondary outcomes (3)

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.
Measured: 180 days from brochure mailing
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.
Measured: 180 days from brochure mailing
Use of Secure Messaging
Patient used the secure messaging feature during the trial
Measured: 180 days from brochure mailing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jul 201930 Sep 2020

First posted2 Nov 2016 (estimated)
Study start22 Jul 2019
Primary completion5 Jul 2020
Study completion30 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 275 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02953262
Sponsor's protocol ID: IIR 15-307
Status last verified: Jul 2023
First submitted: 31 Oct 2016
Last updated: 28 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 32440998
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.
PubMed 32706679
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.
PubMed 34339500
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.
PubMed 34807834

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Diabetes Care Through Effective Personalized Patient Portal Interactions
ClinicalTrials.gov ID: NCT02953262
Acronym / sponsor ID: IIR 15-307
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus, Personal Health Records, Patient Outcome Assessment, Mental Health
Study type: Interventional
Recruitment status: Completed
Enrolment: 275 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 22 Jul 2019 (actual)
Primary completion: 5 Jul 2020 (actual)
Study completion: 30 Sep 2020 (actual)
First posted: 2 Nov 2016 (estimated)
Results: Posted 23 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Encouragement Arm 1	Experimental	Behavioral: My HealtheVet Brochure, Behavioral: My HealtheVet Training Guide for Veterans Living with Diabetes, Behavioral: My HealtheVet Group Training, Behavioral: My HealtheVet Individual TrainingParticipants 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.
Encouragement Arm 2	Experimental	Behavioral: My HealtheVet Brochure, Behavioral: My HealtheVet Training Guide for Veterans Living with Diabetes, Behavioral: My HealtheVet Group TrainingParticipants 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.
Encouragement Arm 3	Experimental	Behavioral: My HealtheVet Training Guide for Veterans Living with Diabetes, Behavioral: My HealtheVet Group TrainingParticipants 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.
Brochure Only Comparison Arm	Other	Behavioral: My HealtheVet Group TrainingThe 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.)

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
My HealtheVet BrochureParticipants will receive a mailed brochure with basic My HealtheVet content.	Behavioural	Encouragement Arm 1, Encouragement Arm 2
My HealtheVet Training Guide for Veterans Living with DiabetesParticipants 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	Behavioural	Encouragement Arm 1, Encouragement Arm 2, Encouragement Arm 3
My HealtheVet Group TrainingParticipants will be invited to participate in a scheduled group training to learn how to use My HealtheVet to help manage their diabetes	Behavioural	Brochure Only Comparison Arm, Encouragement Arm 1, Encouragement Arm 2, Encouragement Arm 3
My HealtheVet Individual TrainingParticipants 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.	Behavioural	Encouragement Arm 1

Primary outcome

Any My HealtheVet Patient Portal Use
Time frame: Portal use within 180 days of initial brochure mailing
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.

3 secondary outcomes

Patient Upgraded to a Premium My HealtheVet Portal Account
Time frame: 180 days from brochure mailing
Use of Online Prescription Refills
Time frame: 180 days from brochure mailing
Use of Secure Messaging
Time frame: 180 days from brochure mailing

Results and safety

Results posted to the registry on 23 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Brochure Only Comparison Arm	68	65
Encouragement Arm 1	69	63
Encouragement Arm 2	68	65
Encouragement Arm 3	70	67

Primary outcome: Any My HealtheVet Patient Portal Use

Time frame: Portal use within 180 days of initial brochure mailing. Count of participants. Unit: Participants

Measure	Brochure Only Comparison Arm n = 65	Encouragement Arm 1 n = 63	Encouragement Arm 2 n = 65	Encouragement Arm 3 n = 67
Value	6	1	5	8

Brochure Only Comparison Arm vs Encouragement Arm 1: p = 0.057, Chi-squared
Brochure Only Comparison Arm vs Encouragement Arm 2: p = 0.753, Chi-squared
Brochure Only Comparison Arm vs Encouragement Arm 3: p = 0.613, Chi-squared

Population analysed: Patients randomized to each arm who had not used My HealtheVet in the 12 months prior to randomization. At the second site, 15 people who should have been excluded were inadvertently included in the sample because the criteria of no secure messaging use in previous 12 months was mistakenly used instead of no patient portal use in the previous 12 months. We did not discover this until after the trial was complete because there were delays in receiving actual portal use data.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for 180 days for each participant. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Comparison Arm	0 of 68 (0%)	0 of 68 (0%)	1 of 68
Encouragement Arm 1	0 of 69 (0%)	0 of 69 (0%)	0 of 69
Encouragement Arm 2	0 of 68 (0%)	0 of 68 (0%)	4 of 68
Encouragement Arm 3	0 of 70 (0%)	0 of 70 (0%)	0 of 70

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 32440998Robinson 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.
Results publication: PubMed 32706679Stewart 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.
Results publication: PubMed 34339500Zocchi 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.
Results publication: PubMed 34807834Robinson 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.
Individual participant dataSharing planned: No

Related trials for Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stephanie L Shimada, PhD principal investigator

VA Bedford HealthCare System, Bedford, MA

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Any My HealtheVet Patient Portal Use (time frame: Portal use within 180 days of initial brochure mailing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02953262, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.