Diabetes MellitusNCT04894903

Effects of a Patient Portal Intervention to Address Diabetes Care Gaps

A study testing Diabetes Care Gaps Patient Portal Intervention in people with Diabetes Mellitus, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetes Mellitus
What is being tested?: Diabetes Care Gaps Patient Portal Intervention
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 440 participants
Where: 1 siteUnited States
Study dates: 30 Apr 2022to 2 Mar 2024
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Established patient with a participating primary care physician from a participating clinic
Type 1 or 2 diabetes mellitus
Able to read in English
Age 18 to 75 years old
Mobile device (smartphone or tablet) with internet access
Active My Health at Vanderbilt (MHAV) account

Who cannot join

A medical condition that prevents use of a mobile device
Pregnant or planning to become pregnant during the study period
Severe difficulty seeing
On dialysis

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37212

Other trials in United States

About this study

Official title: Effects of a Patient Portal Intervention to Address Diabetes Care Gaps: A Pragmatic Randomized Controlled Trial

The purpose of this study is to evaluate the effect of a novel patient portal intervention on the number of patients with diabetes care gaps (e.g., no diabetes eye exam i the last 12 months). The intervention is designed to: (a) notify patients when selected, clinically meaningful, evidence-based diabetes monitoring \& preventative care (e.g., annual urine microalbumin) are due and (b) allow patients to initiate orders for the care.

Read the detailed description

Participants will be recruited from 14 VUMC-affiliate adult primary care clinics located throughout Middle Tennessee. Patients will be randomized 1:1 to the intervention or usual care. 500 adult patients with type 1 or 2 diabetes mellitus will be assigned to one of two arms. 250 will be assigned to receive access to the intervention embedded within an existing patient web portal (My Health at Vanderbilt) at Vanderbilt University Medical Center. 250 will be assigned to a usual care comparison arm with access to the currently available version of My Health at Vanderbilt without the study intervention. At enrollment, participants will complete a baseline questionnaire and diabetes health data will be abstracted from the patients' electronic health record (EHR) before being assigned to the intervention or control arm. Participants will receive additional follow-up questionnaires and diabetes health data will be abstracted from the EHR at 3-month, 6-month, and 12-month follow-ups to assess outcomes. In addition, system usage data (user analytics) will be collected throughout the study period.

Conditions: Diabetes Mellitus
Being tested: Diabetes Care Gaps Patient Portal Intervention
Keywords: Diabetes Mellitus, Self-efficacy, Patient Web Portals, Health Information Technology
Medical subject headings: Diabetes Mellitus

What participants receive

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

Diabetes Care Gaps Patient Portal InterventionOther
The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes monitoring \& preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.

Study groups in NCT04894903
Study group	Role	What they receive
Intervention	Experimental	Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention. . Receives: Other: Diabetes Care Gaps Patient Portal Intervention
Usual Care	No intervention	Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).

What is being measured

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

Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
Number of diabetes care gaps per patient out of four possible:
1. no diabetes eye exam in the last 12 months,
2. no hemoglobin A1C blood test in the last 6 months,
3. no urine microalbumin in the last 12 months, and
4. no pneumococcal vaccination of any kind ( i.e., never received PPSV-23, PCV-13, PCV-15, or PCV-20) The presence of a diabetes care gap will be assessed by electronic health record (EHR) abstraction.
Measured: Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up

Secondary outcomes (9)

Patient Initiated Orders
The number of patient-initiated orders via the study intervention for evidence-based diabetes monitoring and preventative services (e.g., A1c).
Measured: 12-month follow-up
Change in Understanding of Diabetes Monitoring and Preventative Care
Unique study specific items (four items) to assess participant's understanding of measures of diabetes monitoring and preventative care (e.g., Diabetes Eye Exams) will be administered to all study participants. Each multiple-choice item has only one correct answer and the overall measure is scored as the percent of the items answered correctly.
Measured: Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
Change in Confidence Toward Managing Diabetes in General
The 5-item Manage Disease in General Scale of the Chronic Disease Self-Efficacy Scales is a validated measure of the confidence a person has in managing their own health and health care and is closely related to patient activation. The items were adapted to be specific to diabetes rather than a generic condition or illness. Each item uses a 10-point Likert-type scale of response options ranging from 1 (not at all confident) to 10 (totally confident). Responses result in total raw scores ranging from 1 to 10. The score for the scale is the mean of the items. Higher scores indicate greater confidence in managing diabetes in general.
Measured: Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
Change in Diabetes Distress
The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. The PAID-5 contains 5 items which have a five-point response option (0-4 representing 'Not a problem' through to 'Serious problem'). Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress care (e.g., Diabetes Eye Exams) will be administered to all study participants.
Measured: Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
Satisfaction/Usability of My Health at Vanderbilt
The System Usability Scale (SUS) is a valid measure of usability and assesses user's perceptions of ease of use, likability of the interface, and overall satisfaction. Each question on the 10-item questionnaire is scored on a 5-point Likert scale [0 (Strongly disagree) to 4 (strongly agree)] and the sum is totaled (0-40). The total sum is then multiplied by 2.5 to convert the original scores to a range of 0 (worst) to 100 (best). Based on prior research, a score above 68 would be above average and a score of 85 or above suggests excellent usability. The SUS has been used in several studies of patient facing health information technology (the article describing its psychometric properties has been cited over 500 times) and has excellent internal consistency reliability (Cronbach's alpha of 0.91).
Measured: Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up
Change in Blood Glucose Control
Participants' most recent hemoglobin A1C will be abstracted from participants' electronic medical record.
Measured: Baseline to 12-month follow-up
Treatment Intensification
The addition of: (a) antihyperglycemic medications and (b) antihypertensive medications will be assessed by EHR abstraction.
Measured: Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
Change in Diabetes Self-efficacy
The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy (i.e., how confident they feel about their ability to carry out multiple self management tasks). The uni-dimensional, 8-item scale is scored on a five-point Likert scale. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes.
Measured: Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
Reported Services Completed Outside Vanderbilt System
The number of patient reports of diabetes eye exams received outside the Vanderbilt University Medical Center health system submitted via the study intervention.
Measured: 12-month follow-up

Timeline

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

30 Apr 20222 Mar 2024

First posted20 May 2021
Study start30 Apr 2022
Primary completion3 Feb 2024
Study completion2 Mar 2024

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 (1)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 Vanderbilt University Medical CenterThe 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: None (open label)
Enrolment: 440 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04894903
Sponsor's protocol ID: 212257
Other IDs: R18DK123373
Status last verified: Mar 2025
First submitted: 11 May 2021
Last updated: 9 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: After study results are posted on clinical trials and published in a peer-reviewed journal, de-identified individual participant data that underlie the results reported will be available upon requests made to the principal investigator and ending after 36 months after publication.

Publications

Hackstadt AJ, Elasy TA, Gangaputra S, Harper KJ, Mayberry LS, Nelson LA, Peterson NB, Rosenbloom ST, Yu Z, Martinez W. Effects of a Patient Portal Intervention to Address Diabetes Care Gaps: Protocol for a Pragmatic Randomized Controlled Trial. JMIR Res Protoc. 2024 Jun 28;13:e56123. doi: 10.2196/56123.
PubMed 38941148

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 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of a Patient Portal Intervention to Address Diabetes Care Gaps: A Pragmatic Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04894903
Acronym / sponsor ID: 212257
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus, Self-efficacy, Patient Web Portals, Health Information Technology
Study type: Interventional
Recruitment status: Completed
Enrolment: 440 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 30 Apr 2022 (actual)
Primary completion: 3 Feb 2024 (actual)
Study completion: 2 Mar 2024 (actual)
First posted: 20 May 2021 (actual)
Results: Posted 9 Apr 2025

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: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Other: Diabetes Care Gaps Patient Portal InterventionPatients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention. .
Usual Care	No intervention	–Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Established patient with a participating primary care physician from a participating clinic
Type 1 or 2 diabetes mellitus
Able to read in English
Age 18 to 75 years old
Mobile device (smartphone or tablet) with internet access

Key exclusion criteria (4 listed)

A medical condition that prevents use of a mobile device
Pregnant or planning to become pregnant during the study period
Severe difficulty seeing
On dialysis

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
Diabetes Care Gaps Patient Portal InterventionThe Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes monitoring \& preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.	Other	Intervention

Primary outcome

Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
Time frame: Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up
Number of diabetes care gaps per patient out of four possible: 1. no diabetes eye exam in the last 12 months, 2. no hemoglobin A1C blood test in the last 6 months, 3. no urine microalbumin in the last 12 months, and 4. no pneumococcal vaccination of any kind ( i.e., never received PPSV-23, PCV-13, PCV-15, or PCV-20) The presence of a diabetes care gap will be assessed by electronic health record (EHR) abstraction.

9 secondary outcomes

Patient Initiated Orders
Time frame: 12-month follow-up
Change in Understanding of Diabetes Monitoring and Preventative Care
Time frame: Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
Change in Confidence Toward Managing Diabetes in General
Time frame: Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
Change in Diabetes Distress
Time frame: Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
Satisfaction/Usability of My Health at Vanderbilt
Time frame: Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up
Change in Blood Glucose Control
Time frame: Baseline to 12-month follow-up
Treatment Intensification
Time frame: Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
Change in Diabetes Self-efficacy
Time frame: Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
Reported Services Completed Outside Vanderbilt System
Time frame: 12-month follow-up

Results and safety

Results posted to the registry on 9 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	217	213
Intervention	216	212

Primary outcome: Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months

Time frame: Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up. Count of participants. Unit: Participants

Measure	Usual Care n = 215	Intervention n = 216
Baseline: No Care Gaps	75	57
Baseline: One Care Gap	77	79
Baseline: Two Care Gaps	37	56
Baseline: Three Care Gaps	25	18
Baseline: Four Care Gaps	1	6
3-months follow-up: No Care Gaps	83	91
3-months follow-up: One Care Gap	75	87
3-months follow-up: Two Care Gaps	33	26

Usual Care vs Intervention: Odds Ratio (OR): 0.45 (95% CI 0.30 to 0.68), p <0.001, Mixed Models Analysis

Population analysed: Two participants in the control group were excluded from analysis because they dropped out from the study prior to 3-month data collection. The mixed effects regression analysis requires at least one measurement in the follow-up period. Two individuals dropped out prior the any follow-up data collection and therefore are not included in the mixed effects regression analysis.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	7 of 217 (3.2%)	0 of 217 (0%)	1 of 217
Intervention	7 of 216 (3.2%)	0 of 216 (0%)	0 of 216

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38941148Hackstadt AJ, Elasy TA, Gangaputra S, Harper KJ, Mayberry LS, Nelson LA, Peterson NB, Rosenbloom ST, Yu Z, Martinez W. Effects of a Patient Portal Intervention to Address Diabetes Care Gaps: Protocol for a Pragmatic Randomized Controlled Trial. JMIR Res Protoc. 2024 Jun 28;13:e56123. doi: 10.2196/56123.
Individual participant dataSharing planned: Yes. After study results are posted on clinical trials and published in a peer-reviewed journal, de-identified individual participant data that underlie the results reported will be available upon requests made to the principal investigator and ending after 36 months after publication.

Related trials for Diabetes Mellitus

Not yet recruitingPhase 3
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Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
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Recruiting
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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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.

William Martinez, MD, MS principal investigator

Vanderbilt University Medical Center

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

Questions about this trial

What is this clinical trial studying?

A study testing Diabetes Care Gaps Patient Portal Intervention in people with Diabetes Mellitus, run by Vanderbilt University Medical Center at 1 site in United States.

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 6 inclusion and 4 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 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 9 Apr 2025). 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?

Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months (time frame: Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up). 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 NCT04894903, which also lists 1 linked publication.

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 9 Apr 2025.