Improving Diabetes Care Through Effective Personalized Patient Portal Interactions
Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT02953262
Collaborator
(none)
275
2
4
14.3
137.5
9.6
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
275 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Participants were not explicitly told which group they were randomized to but the four groups were described in the information sheet provided to each participant prior to randomization.
Primary Purpose:
Health Services Research
Official Title:
Improving Diabetes Care Through Effective Personalized Patient Portal Interactions
Actual Study Start Date
:
Jul 22, 2019
Actual Primary Completion Date
:
Jul 5, 2020
Actual Study Completion Date
:
Sep 30, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Encouragement Arm 1 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 Brochure
Participants will receive a mailed brochure with basic My HealtheVet content.
Behavioral: 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
|
| Experimental: Encouragement Arm 2 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 Brochure
Participants will receive a mailed brochure with basic My HealtheVet content.
Behavioral: 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
Behavioral: 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
|
| Experimental: Encouragement Arm 3 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 Brochure
Participants will receive a mailed brochure with basic My HealtheVet content.
Behavioral: 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
Behavioral: 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
Behavioral: 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.
|
| Other: Brochure Only Comparison Arm 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 Brochure
Participants will receive a mailed brochure with basic My HealtheVet content.
|
Outcome Measures
Primary Outcome Measures
- Any My HealtheVet Patient Portal Use [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.
Secondary Outcome Measures
- Patient Upgraded to a Premium My HealtheVet Portal Account [180 days from brochure mailing]
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.
- Use of Online Prescription Refills [180 days from brochure mailing]
This measure captures whether the participant used the portal's online prescription refill feature at least once within 180 days of mailing the brochure.
- Use of Secure Messaging [180 days from brochure mailing]
Patient used the secure messaging feature during the trial
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA | Bedford | Massachusetts | United States | 01730 |
| 2 | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | United States | 02130 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Stephanie L Shimada, PhD, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02953262
Other Study ID Numbers:
- IIR 15-307
First Posted:
Nov 2, 2016
Last Update Posted:
Jul 28, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by VA Office of Research and Development
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Patients meeting eligibility criteria were identified from clinical records and mailed an invitation to participate in the study along with a My HealtheVet brochure and an information sheet describing the study. Initial invitations were sent out in June 2019 at Site 1 and in December 2019 at Site 2. Patients who did not opt out were enrolled and randomized into study arms in July 2019 and January 2020, respectively. |
|---|---|
| Pre-assignment Detail | One patient was mistakenly randomized to an arm even though he was deceased shortly prior to enrollment because he met the eligibility criteria according to our databases, including having a future appointment scheduled. Fifteen patients from one site were incorrectly identified as not having used the portal in the 12 months prior to the trial and were excluded from the analyses. |
| Arm/Group Title | Brochure Only Comparison Arm | Encouragement Arm 1 | Encouragement Arm 2 | Encouragement Arm 3 |
|---|---|---|---|---|
| Arm/Group Description | The comparison condition only received a mailed brochure with basic My HealtheVet content during the trial. After the completion of their interview, they were offered a copy of the training guide. | Participants in this encouragement condition received a brochure about the My HealtheVet portal and were mailed 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. | Participants in this encouragement condition received the My HealtheVet brochure and training guide, but was also offered optional attendance at one of several group training sessions. | Participants in this encouragement condition received the same encouragement as in Arm 2 (brochure, training guide and group training offer) but were also offered a one-on-one My HealtheVet training session. |
| Period Title: Overall Study | ||||
| STARTED | 68 | 69 | 68 | 70 |
| COMPLETED | 65 | 63 | 65 | 67 |
| NOT COMPLETED | 3 | 6 | 3 | 3 |
Baseline Characteristics
| Arm/Group Title | Brochure Only Comparison Arm | Encouragement Arm 1 | Encouragement Arm 2 | Encouragement Arm 3 | Total |
|---|---|---|---|---|---|
| Arm/Group Description | The comparison condition only received a mailed brochure with basic My HealtheVet content during the trial. After the completion of their telephone interview, they were offered a copy of the training guide. | Participants in this encouragement condition received a brochure about the My HealtheVet portal and were also mailed 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. | Participants in this encouragement condition received the My HealtheVet brochure and training guide, but were also offered optional attendance at one of several group training sessions. | Participants in this encouragement condition received the same encouragement as in Arm 2 (brochure, training guide and group training offer) but were also offered a one-on-one My HealtheVet training session. | Total of all reporting groups |
| Overall Participants | 65 | 63 | 65 | 67 | 260 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
67.7
(10.3)
|
68.3
(8.8)
|
68.5
(8.8)
|
70.0
(9.1)
|
68.7
(9.2)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
2
3.1%
|
1
1.6%
|
2
3.1%
|
0
0%
|
5
1.9%
|
| Male |
63
96.9%
|
62
98.4%
|
63
96.9%
|
67
100%
|
255
98.1%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||
| White |
54
83.1%
|
47
74.6%
|
57
87.7%
|
55
82.1%
|
213
81.9%
|
| Black/African-American |
5
7.7%
|
6
9.5%
|
4
6.2%
|
5
7.5%
|
20
7.7%
|
| Latino |
4
6.2%
|
5
7.9%
|
4
6.2%
|
0
0%
|
13
5%
|
| Other |
0
0%
|
1
1.6%
|
0
0%
|
2
3%
|
3
1.2%
|
| Unknown/Missing |
2
3.1%
|
4
6.3%
|
0
0%
|
5
7.5%
|
11
4.2%
|
| Region of Enrollment (Count of Participants) | |||||
| United States |
65
100%
|
63
100%
|
65
100%
|
67
100%
|
260
100%
|
| Rural Residence (Count of Participants) | |||||
| Count of Participants [Participants] |
0
0%
|
2
3.2%
|
3
4.6%
|
2
3%
|
7
2.7%
|
| Marital Status (Count of Participants) | |||||
| Married |
30
46.2%
|
30
47.6%
|
31
47.7%
|
34
50.7%
|
125
48.1%
|
| Widowed |
4
6.2%
|
4
6.3%
|
5
7.7%
|
3
4.5%
|
16
6.2%
|
| Divorced/Separated |
19
29.2%
|
14
22.2%
|
24
36.9%
|
18
26.9%
|
75
28.8%
|
| Single |
12
18.5%
|
15
23.8%
|
5
7.7%
|
12
17.9%
|
44
16.9%
|
| Average HbA1c at baseline (2019) (% (DCCT units)) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [% (DCCT units)] |
9.6
(1.3)
|
9.3
(1.0)
|
9.5
(1.3)
|
9.3
(1.1)
|
9.4
(1.2)
|
Outcome Measures
| Title | Any My HealtheVet Patient Portal Use |
|---|---|
| Description | 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. |
| Time Frame | Portal use within 180 days of initial brochure mailing |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Brochure Only Comparison Arm | Encouragement Arm 1 | Encouragement Arm 2 | Encouragement Arm 3 |
|---|---|---|---|---|
| Arm/Group Description | 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 6-month interview.) Brochure Only Intervention 4: Participants will receive a mailed brochure with basic My HealtheVet content. | 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. Supported Adopted Intervention 1: Participants in this encouragement condition will receive a mailed brochure 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. Brochure Only Intervention 4: Participants will receive a mailed brochure with basic My HealtheVet content. | 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. Supported Adopted Intervention 1: Participants in this encouragement condition will receive a mailed brochure 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. Supported Adopted Intervention 2: Participants will be offered optional attendance at a group training session in addition to receiving the brochure and training guide by mail. These sessions will be offered at a computer lab at the VA hospital. Brochure Only Intervention 4: Participants will receive a mailed brochure with basic My HealtheVet content. | 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. Supported Adopted Intervention 1: Participants in this encouragement condition will receive a mailed brochure 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. Supported Adopted Intervention 2: Participants will be offered optional attendance at a group training session in addition to receiving the brochure and training guide by mail. These sessions will be offered at a computer lab at the VA hospital. Supported Adopted Intervention 3: Participants will also be offered a one-on-one My HealtheVet training session in addition to the brochure, training guide, and offer of group training session. Brochure Only Intervention 4: Participants will receive a mailed brochure with basic My HealtheVet content. |
| Measure Participants | 65 | 63 | 65 | 67 |
| Count of Participants [Participants] |
6
9.2%
|
1
1.6%
|
5
7.7%
|
8
11.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Brochure Only Comparison Arm, Encouragement Arm 1 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.057 |
| Comments | The a priori threshold for statistical significance was p=0.05. | |
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Brochure Only Comparison Arm, Encouragement Arm 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.753 |
| Comments | The a priori threshold for statistical significance was p=0.05. | |
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Brochure Only Comparison Arm, Encouragement Arm 3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.613 |
| Comments | The a priori threshold for statistical significance was p=0.05. | |
| Method | Chi-squared | |
| Comments | ||
| Title | Patient Upgraded to a Premium My HealtheVet Portal Account |
|---|---|
| Description | 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. |
| Time Frame | 180 days from brochure mailing |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Brochure Only Comparison Arm | Encouragement Arm 1 | Encouragement Arm 2 | Encouragement Arm 3 |
|---|---|---|---|---|
| Arm/Group Description | 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.) My HealtheVet Brochure: Participants will receive a mailed brochure with basic My HealtheVet content. | 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. 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 | 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. 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 | 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. 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. |
| Measure Participants | 65 | 63 | 65 | 67 |
| Count of Participants [Participants] |
0
0%
|
1
1.6%
|
2
3.1%
|
5
7.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Brochure Only Comparison Arm, Encouragement Arm 1 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.308 |
| Comments | The a priori threshold for statistical significance was p=0.05. | |
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Brochure Only Comparison Arm, Encouragement Arm 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.154 |
| Comments | The a priori threshold for statistical significance was p=0.05. | |
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Brochure Only Comparison Arm, Encouragement Arm 3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.025 |
| Comments | The a priori threshold for statistical significance was p=0.05. | |
| Method | Chi-squared | |
| Comments | ||
| Title | Use of Online Prescription Refills |
|---|---|
| Description | This measure captures whether the participant used the portal's online prescription refill feature at least once within 180 days of mailing the brochure. |
| Time Frame | 180 days from brochure mailing |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Brochure Only Comparison Arm | Encouragement Arm 1 | Encouragement Arm 2 | Encouragement Arm 3 |
|---|---|---|---|---|
| Arm/Group Description | 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.) My HealtheVet Brochure: Participants will receive a mailed brochure with basic My HealtheVet content. | 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. 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 | 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. 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 | 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. 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. |
| Measure Participants | 65 | 63 | 65 | 67 |
| Count of Participants [Participants] |
5
7.7%
|
1
1.6%
|
0
0%
|
3
4.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Brochure Only Comparison Arm, Encouragement Arm 1 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.102 |
| Comments | The a priori threshold for statistical significance was p=0.05. | |
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Brochure Only Comparison Arm, Encouragement Arm 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.023 |
| Comments | The a priori threshold for statistical significance was p=0.05. | |
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Brochure Only Comparison Arm, Encouragement Arm 3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.439 |
| Comments | The a priori threshold for statistical significance was p=0.05. | |
| Method | Chi-squared | |
| Comments | ||
| Title | Use of Secure Messaging |
|---|---|
| Description | Patient used the secure messaging feature during the trial |
| Time Frame | 180 days from brochure mailing |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Brochure Only Comparison Arm | Encouragement Arm 1 | Encouragement Arm 2 | Encouragement Arm 3 |
|---|---|---|---|---|
| Arm/Group Description | 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.) My HealtheVet Brochure: Participants will receive a mailed brochure with basic My HealtheVet content. | 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. 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 | 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. 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 | 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. 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. |
| Measure Participants | 65 | 63 | 65 | 67 |
| Count of Participants [Participants] |
1
1.5%
|
1
1.6%
|
2
3.1%
|
7
10.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Brochure Only Comparison Arm, Encouragement Arm 1 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.982 |
| Comments | The a priori threshold for statistical significance was p=0.05. | |
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Brochure Only Comparison Arm, Encouragement Arm 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.559 |
| Comments | The a priori threshold for statistical significance was p=0.05. | |
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Brochure Only Comparison Arm, Encouragement Arm 3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.032 |
| Comments | The a priori threshold for statistical significance was p=0.05. | |
| Method | Chi-squared | |
| Comments | ||
Adverse Events
| Time Frame | Adverse events were collected for 180 days for each participant | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Patient deaths during the trial were typically discovered from communication with family members when reaching out to participants by telephone to schedule a training session or interview. These deaths were unrelated to participation in the trial but were reported to the institutional review board when discovered. | |||||||
| Arm/Group Title | Comparison Arm | Encouragement Arm 1 | Encouragement Arm 2 | Encouragement Arm 3 | ||||
| Arm/Group Description | The Comparison condition received a mailed brochure with basic My HealtheVet information. They were offered a training guide at the end of the study (after their interview). | Participants in this encouragement condition received the mailed brochure 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. | Participants in this encouragement condition received the brochure and the same training guide as Arm 1 but were also offered optional attendance at one of several group training sessions. | Participants in this encouragement condition received the same as in Arm 2 (brochure, training guide and group training offer) but were also offered a one-on-one My HealtheVet training | ||||
All Cause Mortality |
||||||||
| Comparison Arm | Encouragement Arm 1 | Encouragement Arm 2 | Encouragement Arm 3 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/68 (1.5%) | 0/69 (0%) | 4/68 (5.9%) | 0/70 (0%) | ||||
Serious Adverse Events |
||||||||
| Comparison Arm | Encouragement Arm 1 | Encouragement Arm 2 | Encouragement Arm 3 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/68 (0%) | 0/69 (0%) | 0/68 (0%) | 0/70 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Comparison Arm | Encouragement Arm 1 | Encouragement Arm 2 | Encouragement Arm 3 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/68 (0%) | 0/69 (0%) | 0/68 (0%) | 0/70 (0%) | ||||
Limitations/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.
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Stephanie Shimada, PhD |
|---|---|
| Organization | Center for Healthcare Organization and Implementation Research (CHOIR) United States Department of Veterans Affairs VA Bedford Healthcare System |
| Phone | 781-687-2208 |
| Stephanie.Shimada@va.gov |
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02953262
Other Study ID Numbers:
- IIR 15-307
First Posted:
Nov 2, 2016
Last Update Posted:
Jul 28, 2021
Last Verified:
Jul 1, 2021