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Diabetes Mellitus, Type 2AURORANCT05754008

Care Navigator Support for Younger Latinx Adults With Type 2 Diabetes

A study testing AURORA Care Strategy in people with Diabetes Mellitus, Type 2, run by Kaiser Permanente at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study proposes to rigorously evaluate a proactive, culturally responsive care navigator intervention targeting younger-onset Latinx individuals with a new T2D diagnosis (AURORA [Active Outreach to Younger Latinx]) within Kaiser Permanente Northern California (KPNC). Read more about this study

Who is it for?
Ages 21 to 44 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
AURORA Care Strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
1 siteUnited States
Study dates
31 Mar 2023to Dec 2025
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 21 to 44 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • KPNC member, age >20 and age <45 with
  • New clinical diagnosis of T2D within the prior 1-8 months
  • HbA1c≥8%. If the study team are having trouble recruiting an adequate sample, the study team may lower the HbA1c threshold to ≥7.5%
  • Proficient (written and spoken) in English or Spanish

Who cannot join

  • Pregnant women
  • Type 1 Diabetes

Trial locations and contacts

1 site in 1 country.

Amy Valdati contact

510-410-6659

amy.valdati@kp.org

United States1 site, 1 recruiting

  • Kaiser Permanente Northern California

    Oakland, California, 94612

    Amy Valdati

    Recruiting

Other trials in United States

About this study

Official title: A Randomized Trial of Care Navigator to Support Younger Latinx Adults Newly Diagnosed With Type 2 Diabetes (AURORA)

The study proposes to rigorously evaluate a proactive, culturally responsive care navigator intervention targeting younger-onset Latinx individuals with a new T2D diagnosis (AURORA [Active Outreach to Younger Latinx]) within Kaiser Permanente Northern California (KPNC).

Read the detailed description

The study has three primary objectives: 1) learn what is required to create and sustain a care navigator workforce and document our experience hiring a care navigator for the study, 2) implement and evaluate the AURORA strategy within KPNC, and 3) refine and adapt the AURORA strategy for future Kaiser Permanente (KP) wide dissemination. The AURORA strategy centers on a care navigator who will proactively conduct three telemedicine visits tailored to Latinx adults with early onset type 2 diabetes (T2D, defined as age <45 years). The AURORA strategy will conducted with the following five goals: 1) assessment of familiarity and use of T2D care within KP, 2) assessment of individual's self-management support needs, 3) motivational interviewing to support behavior change, 4) pragmatic skills training, including use of crucial technologies to support self-management, and 5) matching member's needs with existing KPNC T2D resources.

Being tested
AURORA Care Strategy
Keywords
Care Navigator, Latinx
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.

  • AURORA Care StrategyBehavioural

    Participants will be invited to partake in three telemedicine visits with the care navigator during the months following diagnosis. The visits center around proactive and tailored T2D self-management support.

Study groups in NCT05754008
Study groupRoleWhat they receive
AURORA Care StrategyExperimentalParticipants will receive the AURORA Care Strategy in addition to their usual diabetes care.
Receives: Behavioral: AURORA Care Strategy
Usual CareNo interventionNo intervention will be employed. This arm will continue to receive their usual diabetes care.

What is being measured

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

  1. Differences between study arms in HbA1c change 6-months following enrollment

    Change in HbA1c will be assessed using HbA1c values obtained through routine care, with the most recent HbA1c preceding study enrollment and the HbA1c value closest to 6-months following enrollment used to assess HbA1c change.

    Measured: 6-months following enrollment

Secondary outcomes (11)

  1. Healthcare contact

    Differences in healthcare contact with members of the T2D diabetes care team, including care manager, PCPs, educators.

    Measured: 6-months following enrollment

  2. Completion of recommended HbA1c monitoring

    Completing HbA1c labs

    Measured: 6-months following enrollment

  3. T2D-related medication initiation

    Initiation of T2D-related medication

    Measured: 6-months following enrollment

  4. T2D-related medication adherence

    Adherence to T2D-related medication

    Measured: 6-months following enrollment

  5. Use of remote glucose monitoring to measure glucose levels

    Use of a remote glucose monitoring to measure glucose levels

    Measured: 6-months following enrollment

  6. Participant-reported measures: Confidence in Accessing Care

    Assessed at 3-month survey

    Measured: 3-months following enrollment

  7. Participant-reported measures: Diet and Exercise

    Assessed at 3-month survey

    Measured: 3-months following enrollment

  8. Participant-reported measures: Self-efficacy for diabetes

    Assessed at 3-month survey

    Measured: 3-months following enrollment

  9. Participant-reported measures: Motivation and locus of control

    Assessed at 3-month survey

    Measured: 3-months following enrollment

  10. Participant-reported measures: Diabetes distress

    Assessed at 3-month survey

    Measured: 3-months following enrollment

  11. Participant-reported measures: Diabetes stigma

    Assessed at 3-month survey

    Measured: 3-months following enrollment

Timeline

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

  1. First posted3 Mar 2023
  2. Study start31 Mar 2023
  3. Primary completion1 Apr 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study team will conduct a patient-level randomized, parallel-group pragmatic trial of usual care vs. the AURORA care strategy among Latinx members (ages 18-44), recently diagnosed with T2D with a diagnosis HbA1c ≥8% (n=102/study arm). Outcomes assessed at 6 months post-enrollment will include HbA1c changes, medication initiation and adherence, and changes in patient-reported measures (e.g., self-efficacy).
Masking
None (open label)
Enrolment
204 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05754008
Sponsor's protocol ID
1833646
Acronym
AURORA
Status last verified
May 2024
First submitted
23 Feb 2023
Last updated
3 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Wilmot E, Idris I. Early onset type 2 diabetes: risk factors, clinical impact and management. Ther Adv Chronic Dis. 2014 Nov;5(6):234-44. doi: 10.1177/2040622314548679.

    PubMed 25364491

  • Gopalan A, Mishra P, Alexeeff SE, Blatchins MA, Kim E, Man A, Karter AJ, Grant RW. Initial Glycemic Control and Care Among Younger Adults Diagnosed With Type 2 Diabetes. Diabetes Care. 2020 May;43(5):975-981. doi: 10.2337/dc19-1380. Epub 2020 Mar 4.

    PubMed 32132007

  • Laiteerapong N, Ham SA, Gao Y, Moffet HH, Liu JY, Huang ES, Karter AJ. The Legacy Effect in Type 2 Diabetes: Impact of Early Glycemic Control on Future Complications (The Diabetes & Aging Study). Diabetes Care. 2019 Mar;42(3):416-426. doi: 10.2337/dc17-1144. Epub 2018 Aug 13.

    PubMed 30104301

  • Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008 Oct 9;359(15):1577-89. doi: 10.1056/NEJMoa0806470. Epub 2008 Sep 10.

    PubMed 18784090

  • American Diabetes Association. 1. Improving Care and Promoting Health in Populations: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S7-S14. doi: 10.2337/dc21-S001.

    PubMed 33298412

  • Hildebrand JA, Billimek J, Lee JA, Sorkin DH, Olshansky EF, Clancy SL, Evangelista LS. Effect of diabetes self-management education on glycemic control in Latino adults with type 2 diabetes: A systematic review and meta-analysis. Patient Educ Couns. 2020 Feb;103(2):266-275. doi: 10.1016/j.pec.2019.09.009. Epub 2019 Sep 9.

    PubMed 31542186

  • Flores-Luevano S, Pacheco M, Shokar GS, Dwivedi AK, Shokar NK. Impact of a Culturally Tailored Diabetes Education and Empowerment Program in a Mexican American Population Along the US/Mexico Border: A Pragmatic Study. J Clin Med Res. 2020 Aug;12(8):517-529. doi: 10.14740/jocmr4273. Epub 2020 Jul 22.

    PubMed 32849940

  • Rosal MC, Ockene IS, Restrepo A, White MJ, Borg A, Olendzki B, Scavron J, Candib L, Welch G, Reed G. Randomized trial of a literacy-sensitive, culturally tailored diabetes self-management intervention for low-income latinos: latinos en control. Diabetes Care. 2011 Apr;34(4):838-44. doi: 10.2337/dc10-1981. Epub 2011 Mar 4.

    PubMed 21378213

  • Islam NS, Wyatt LC, Taher MD, Riley L, Tandon SD, Tanner M, Mukherji BR, Trinh-Shevrin C. A Culturally Tailored Community Health Worker Intervention Leads to Improvement in Patient-Centered Outcomes for Immigrant Patients With Type 2 Diabetes. Clin Diabetes. 2018 Apr;36(2):100-111. doi: 10.2337/cd17-0068.

    PubMed 29686448

  • Spencer MS, Gunter KE, Palmisano G. Community health workers and their value to social work. Soc Work. 2010 Apr;55(2):169-80. doi: 10.1093/sw/55.2.169.

    PubMed 20408358

  • Hartzler AL, Tuzzio L, Hsu C, Wagner EH. Roles and Functions of Community Health Workers in Primary Care. Ann Fam Med. 2018 May;16(3):240-245. doi: 10.1370/afm.2208.

    PubMed 29760028

  • Adair R, Wholey DR, Christianson J, White KM, Britt H, Lee S. Improving chronic disease care by adding laypersons to the primary care team: a parallel randomized trial. Ann Intern Med. 2013 Aug 6;159(3):176-84. doi: 10.7326/0003-4819-159-3-201308060-00007.

    PubMed 23922063

  • Palmas W, March D, Darakjy S, Findley SE, Teresi J, Carrasquillo O, Luchsinger JA. Community Health Worker Interventions to Improve Glycemic Control in People with Diabetes: A Systematic Review and Meta-Analysis. J Gen Intern Med. 2015 Jul;30(7):1004-12. doi: 10.1007/s11606-015-3247-0. Epub 2015 Mar 4.

    PubMed 25735938

  • Kvedar J, Coye MJ, Everett W. Connected health: a review of technologies and strategies to improve patient care with telemedicine and telehealth. Health Aff (Millwood). 2014 Feb;33(2):194-9. doi: 10.1377/hlthaff.2013.0992.

    PubMed 24493760

  • Ray KN, Chari AV, Engberg J, Bertolet M, Mehrotra A. Disparities in Time Spent Seeking Medical Care in the United States. JAMA Intern Med. 2015 Dec;175(12):1983-6. doi: 10.1001/jamainternmed.2015.4468. No abstract available.

    PubMed 26437386

Questions about this trial

What is this clinical trial studying?

A study testing AURORA Care Strategy in people with Diabetes Mellitus, Type 2, run by Kaiser Permanente 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 4 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: status not confirmed, as of the sponsor's last update on 3 May 2024. 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?

Results are not available in the source record.

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

Contact Amy Valdati (510-410-6659, amy.valdati@kp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences between study arms in HbA1c change 6-months following enrollment (time frame: 6-months following enrollment). 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 NCT05754008, which also lists 32 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 3 May 2024.

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