Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Diabetes Care Through Effective Personalized Patient Portal Interactions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02953262
Recruitment Status : Not yet recruiting
First Posted : November 2, 2016
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Patient-facing eHealth technologies are those that connect patients and the healthcare system, and include online patient portals. Although many organizations are adopting patient portals, there is limited understanding of how the different portal features help improve health outcomes. This study is designed to develop and test an intervention to improve adoption and use of patient portal features for diabetes management.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: Supported Adopted Intervention 1 Behavioral: Supported Adopted Intervention 2 Behavioral: Supported Adopted Intervention 3 Behavioral: Attention Control Intervention 4 Not Applicable

Detailed Description:

Currently over 3 million Veterans have adopted the VA Patient Portal, My HealtheVet (MHV), however actual use of the portal varies considerably, and we are only beginning to understand how the portal features can best improve patient outcomes, or whether effective use varies by subgroups. By examining the patient portal features associated with improved outcomes and clarifying how patients can best leverage these features to better manage their diabetes, the investigators will develop and test an intervention to improve adoption and use of the patient portal for diabetes management. The goal of this small scale study, using a randomized encouragement design, is to test the feasibility of engaging Veterans in a supported adoption intervention to promote effective MHV use, in a sample of Veterans with diabetes (with or without comorbid mental health problems).

The investigators will recruit from Veterans age 18-85 who are actively receiving care at the study sites (as determined by upcoming scheduled appointment) who have uncontrolled glucose (HbA1c >= 8.5%) and have never used the VA patient portal or are inactive registrants who have not used the patient portal in the past 12 months. Participants who meet these conditions and do not opt out of the study will be randomized to one of four conditions: 1) Encouragement I (mailed training guide), 2) Encouragement II (mailed training guide+ invitation to group training), 3) Encouragement III (mailed training guide+invitation to group and one-on-one training), and 4) Comparison (standard patient portal enrollment brochure only). All those invited will receive a mailing with the standard My HealtheVet patient portal enrollment brochure and information about the study. Those randomized to the Encouragement arms will receive a mailed training guide. Those in Encouragement II will receive an invitation to attend one of several group training sessions at a VA computer lab (which will emphasize the features most meaningful for diabetes management). Those in Encouragement III will be invited to schedule a one-on one session (to sign up and learn how to use the patient portal. Those in the comparison condition will receive a mailing with only the standard My HealtheVet trifold brochure that provides information on how to register. They will be mailed a training guide at the completion of the trial.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Diabetes Care Through Effective Personalized Patient Portal Interactions
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Arm Intervention/treatment
Experimental: Encouragement Arm 1
Participants in this encouragement condition will receive 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: Supported Adopted Intervention 1
Participants in this encouragement condition will receive 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: Attention Control Intervention 4
Participants will receive a mailed brochure with basic My HealtheVet content.

Experimental: Encouragement Arm 2
Participants in this encouragement condition will receive the same training guide as Arm 1 but will also be offered optional attendance at one of several group training sessions.
Behavioral: Supported Adopted Intervention 1
Participants in this encouragement condition will receive 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: Supported Adopted Intervention 2
Participants will be offered optional attendance at a group training session. These sessions will be offered at least every other week at a computer lab at the VA hospital.

Behavioral: Attention Control Intervention 4
Participants will receive a mailed brochure with basic My HealtheVet content.

Experimental: Encouragement Arm 3
Participants in this encouragement condition will receive the same as in Arm 2 (training guide and group training offer) but will also be offered a one-on-one My HealtheVet training
Behavioral: Supported Adopted Intervention 1
Participants in this encouragement condition will receive 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: Supported Adopted Intervention 2
Participants will be offered optional attendance at a group training session. These sessions will be offered at least every other week at a computer lab at the VA hospital.

Behavioral: Supported Adopted Intervention 3
Participants will also be offered a one-on-one My HealtheVet training.

Behavioral: Attention Control Intervention 4
Participants will receive a mailed brochure with basic My HealtheVet content.

Attention Control Comparison Arm
The Comparison condition will receive a mailed brochure with basic My HealtheVet content.
Behavioral: Attention Control Intervention 4
Participants will receive a mailed brochure with basic My HealtheVet content.




Primary Outcome Measures :
  1. Changes in My HealtheVet patient portal use [ Time Frame: Baseline & 6 month follow up ]
    The investigators will examine the changes in use of MHV from baseline to 6 month follow-up, including use of secure messaging, Blue Button, and prescription refills.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953262


Contacts
Layout table for location contacts
Contact: Stephanie L Shimada, PhD (781) 687-2208 stephanie.shimada@va.gov
Contact: Timothy P Hogan, PhD MS BS (781) 687-3181 timothy.hogan@va.gov

Locations
Layout table for location information
United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA Enrolling by invitation
Bedford, Massachusetts, United States, 01730
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Not yet recruiting
Boston, Massachusetts, United States, 02130
Contact: Stephanie L Shimada, PhD    781-687-2208    stephanie.shimada@va.gov   
Sub-Investigator: Mark S Bauer, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Stephanie L Shimada, PhD Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02953262     History of Changes
Other Study ID Numbers: IIR 15-307
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Diabetes Mellitus
Personal Health Records
Patient Outcome Assessment
Mental Health

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases