Type 2 DiabetesNCT06283992
Digital Health Navigation for Latino Patients With Type II Diabetes
A study testing Digital Navigation in people with Type 2 Diabetes, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about digital literacy training in adult, Latino patient with type II diabetes. The main question it aims to answer is: Can providing digital literacy training during a hospital admission can help patients with their after-hospital care by using the patient portal and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Digital Navigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identified Latino adult patients with type II diabetes
- Admitted to general medicine floors at Brigham and Women's Hospital
- Preferred language: English or Spanish
Who cannot join
- Critical illness
- dementia, delirium, or other condition that limits ability to participate in education and consent process
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Official title: Digital Health Navigation for Latino Patients With Type II Diabetes: A Randomized Controlled Trial
The goal of this clinical trial is to learn about digital literacy training in adult, Latino patient with type II diabetes. The main question it aims to answer is: Can providing digital literacy training during a hospital admission can help patients with their after-hospital care by using the patient portal and telehealth? Participants will receive digital literacy training by a digital navigator that focuses on the main patient portal functions. Researchers will compare patients who receive digital literacy training to those who receive standard of care (educational sheet) to see if it impacts their use of the patient portal after discharge.
Read the detailed description
Latinos have the second-highest age-adjusted prevalence and among the highest incidence of diabetes. Latinos also experience worse glycemic control and diabetes-related complications, including diabetic retinopathy and chronic renal disease. These findings are concerning since Latinos are the largest minority group in the U.S and will account for 25% of the population by 2045.
Digital tools, like patient portals and telemedicine, offer an opportunity to address some of the challenges that lead to these disparities, especially during care transitions. However, Latinos, especially those who are Spanish-speaking are less likely to use digital health tools. Findings from previous health information technology work have highlighted barriers, including 1) digital access and literacy, 2) interface usability, 3) privacy, and 4) patient preference. One promising intervention to address digital literacy gaps is the use digital navigators.
This study aims are to assess a digital health navigation intervention focused on increasing patient portal use after discharge among Latino patients with type II diabetes admitted to the general medicine inpatient floor.
- Conditions
- Type 2 Diabetes
- Being tested
- Digital Navigation
- Keywords
- Latinos
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital NavigationOther
1:1 educational support at the bedside about the functions of the patient portal and telehealth that can help with care transitions.
| Study group | Role | What they receive |
|---|---|---|
| Digital Navigation | Experimental | Patients in this arm will receive 1:1 digital navigation support which will teach them about the functions of the patient portal and telehealth. Receives: Other: Digital Navigation |
| Standard of Care | No intervention | Patients in this arm will receive the standard of care which will be an educational sheet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Who Login to the Portal
Number of participants with at least 1 login to the portal in the 30 days after discharge
Measured: 30 days post-discharge
Secondary outcomes (3)
Proportion of Participants that Perform Distinct Portal Functions
Proportion of participants that perform distinct portal functions (sending messages, requesting refill)
Measured: 30 days post-discharge
Proportion of participants that complete a telehealth
Proportion of participants that complete a telehealth visit during post-discharge period
Measured: 30 days post-discharge
Proportion of participants that are re-admitted
Proportion of participants that are re-admitted within 30 days after discharge
Measured: 30 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start31 Mar 2024
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Model description
- Researchers will compare effectiveness between two arms: 1) patient education using a digital navigator on using digital tools after discharge and 2) usual care (educational sheet).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Jorge A. Rodriguez, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283992
- Sponsor's protocol ID
- 2024p000095
- Other IDs
- K23MD016439
- Status last verified
- Aug 2026
- First submitted
- 21 Feb 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is no current plan to share data with other researchers.
Publications
Rodriguez JA, Charles JP, Bates DW, Lyles C, Southworth B, Samal L. Digital healthcare equity in primary care: implementing an integrated digital health navigator. J Am Med Inform Assoc. 2023 Apr 19;30(5):965-970. doi: 10.1093/jamia/ocad015.
PubMed 36795062
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Health Navigation for Latino Patients With Type II Diabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06283992
- Acronym / sponsor ID
- 2024p000095
- Conditions
- Type 2 Diabetes
- Keywords
- Latinos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 31 Mar 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn about digital literacy training in adult, Latino patient with type II diabetes. The main question it aims to answer is: Can providing digital literacy training during a hospital admission can help patients with their after-hospital care by using the patient portal and telehealth? Participants will receive digital literacy training by a digital navigator that focuses on the main patient portal functions. Researchers will compare patients who receive digital literacy training to those who receive standard of care (educational sheet) to see if it impacts their use of the patient portal after discharge.
Detailed description
Latinos have the second-highest age-adjusted prevalence and among the highest incidence of diabetes. Latinos also experience worse glycemic control and diabetes-related complications, including diabetic retinopathy and chronic renal disease. These findings are concerning since Latinos are the largest minority group in the U.S and will account for 25% of the population by 2045.
Digital tools, like patient portals and telemedicine, offer an opportunity to address some of the challenges that lead to these disparities, especially during care transitions. However, Latinos, especially those who are Spanish-speaking are less likely to use digital health tools. Findings from previous health information technology work have highlighted barriers, including 1) digital access and literacy, 2) interface usability, 3) privacy, and 4) patient preference. One promising intervention to address digital literacy gaps is the use digital navigators.
This study aims are to assess a digital health navigation intervention focused on increasing patient portal use after discharge among Latino patients with type II diabetes admitted to the general medicine inpatient floor.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Researchers will compare effectiveness between two arms: 1) patient education using a digital navigator on using digital tools after discharge and 2) usual care (educational sheet).
| Arm | Type | Receives |
|---|---|---|
| Digital Navigation | Experimental | Other: Digital NavigationPatients in this arm will receive 1:1 digital navigation support which will teach them about the functions of the patient portal and telehealth. |
| Standard of Care | No intervention | –Patients in this arm will receive the standard of care which will be an educational sheet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-identified Latino adult patients with type II diabetes
- Admitted to general medicine floors at Brigham and Women's Hospital
- Preferred language: English or Spanish
Key exclusion criteria (2 listed)
- Critical illness
- dementia, delirium, or other condition that limits ability to participate in education and consent process
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 |
|---|---|---|
| Digital Navigation1:1 educational support at the bedside about the functions of the patient portal and telehealth that can help with care transitions. | Other | Digital Navigation |
Primary outcome
Proportion of Participants Who Login to the Portal
Time frame: 30 days post-discharge
Number of participants with at least 1 login to the portal in the 30 days after discharge
3 secondary outcomes
Proportion of Participants that Perform Distinct Portal Functions
Time frame: 30 days post-discharge
Proportion of participants that complete a telehealth
Time frame: 30 days post-discharge
Proportion of participants that are re-admitted
Time frame: 30 days post-discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 36795062Rodriguez JA, Charles JP, Bates DW, Lyles C, Southworth B, Samal L. Digital healthcare equity in primary care: implementing an integrated digital health navigator. J Am Med Inform Assoc. 2023 Apr 19;30(5):965-970. doi: 10.1093/jamia/ocad015.
- Individual participant dataSharing planned: Undecided. There is no current plan to share data with other researchers.
Related trials for Type 2 Diabetes
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
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Navigation in people with Type 2 Diabetes, run by Brigham and Women's Hospital 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 3 inclusion and 2 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 12 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of Participants Who Login to the Portal (time frame: 30 days post-discharge). 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 NCT06283992, 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 12 Aug 2026.