Care Navigator Support for Younger Latinx Adults With Type 2 Diabetes

NCT05754008 | Recruiting

• 1 other identifier: 1833646
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Diabetes Mellitus, Type 2

Keywords

Care Navigator, Latinx

Outcome Measures

Primary Outcomes (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.

  6-months following enrollment

Secondary Outcomes (11)

• Healthcare contact

  6-months following enrollment

• Completion of recommended HbA1c monitoring

  6-months following enrollment

• T2D-related medication initiation

  6-months following enrollment

• T2D-related medication adherence

  6-months following enrollment

• Use of remote glucose monitoring to measure glucose levels

  6-months following enrollment

Study Arms (2)

AURORA Care Strategy

EXPERIMENTAL

Participants will receive the AURORA Care Strategy in addition to their usual diabetes care.

Behavioral: AURORA Care Strategy

Usual Care

NO INTERVENTION

No intervention will be employed. This arm will continue to receive their usual diabetes care.

Interventions

AURORA Care Strategy BEHAVIORAL

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.

AURORA Care Strategy

Eligibility Criteria

• Age: 21 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnant women
• Type 1 Diabetes

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Northern California

Oakland, California, 94612, United States

RECRUITING

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  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Anjali Gopalan, MD, MS

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Valdati

CONTACT

510-410-6659; amy.valdati@kp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 3, 2023
• Study Start: March 31, 2023
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

US (1)