N/A
Completed N=110
Addressing Social Determinants of Health & Diabetes Self-Management in Vulnerable Populations
Source: ClinicalTrials.gov NCT03802825 ↗Enrolled (actual)
110
Serious AEs
12.7%
Results posted
Nov 2022
Primary outcomePrimary: Percent of Participants With A1C < 8% — 33; 34 percent of participants
Summary
In this pilot and feasibility study, the investigator will randomize 100 African-American, Hispanic, and/or Medicaid (all race/ethnicities) patients from KPNW with A1C ≥ 8 to one of two 6-month interventions: 1) patient navigation only; or 2) patient navigation + diabetes self-management training. Feasibility of a large-scale, pragmatic, randomized trial will be determined and preliminary effectiveness of treatment arms on A1C reduction among racial/ethnic minority and low-income patients with poorly managed diabetes will be examined.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With A1C < 8% |
33; 34 | — |
| SECONDARY Emergency Department (ED) Visits |
0.96; 1.07 | — |
| SECONDARY Primary Care Visit No-show Rate |
0.85; 0.88 | — |
| SECONDARY Medication Refills |
27; 20 | — |
| SECONDARY Mean A1C Change |
0.65; 0.72 | — |
Eligibility Criteria
Inclusion Criteria
- Diabetes diagnosis
- Current Kaiser Permanente Northwest member
- African-American, Hispanic/Latino (English, Spanish-speaking, or bilingual), and/or a Medicaid recipient (from any racial or ethnic background)
- Age 18 or older
- Most recent hemoglobin A1C test of ≥ 8
- Endorses 1 or more social and/or economic need on the Your Current Life Situation assessment
Exclusion Criteria
- Patients who are unable to provide informed consent due to cognitive or psychiatric impairment.
Data sourced from ClinicalTrials.gov (NCT03802825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.