NCT03802825

Addressing Social Determinants of Health & Diabetes Self-Management in Vulnerable Populations

Completed NA Results posted Last updated 29 November 2022

What this trial tests

NA trial testing Diabetes Self-Management Training in Diabetes in 110 participants. Completed in 30 June 2021.

Timeline

1 March 2019

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	Kaiser Permanente
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	110
Start date	1 March 2019
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Diabetes Self-Management Training
• Standard Patient Navigation

Conditions studied

• Diabetes — all drugs for Diabetes →

Sponsor

Kaiser Permanente — full company profile →

Who can join

18 and older, any sex, with Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent of Participants With A1C < 8% Primary · 6 months

Using ITT analysis, percent of participants in each arm with A1C \< 8% at 6-month follow-up was calculated.

Group	Value	95% CI
Patient Navigation	33
Patient Navigation+Diabetes Self-Management Support	34

Emergency Department (ED) Visits Secondary · 6 months

Mean number of visits to the emergency department over the 6-month duration of the intervention.

Group	Value	95% CI
Patient Navigation	0.96	± 1.70
Patient Navigation+Diabetes Self-Management Support	1.07	± 2.95

Primary Care Visit No-show Rate Secondary · 6 months

Mean number of missed primary care visits over duration of the intervention (6 months)

Group	Value	95% CI
Patient Navigation	0.85	± 1.29
Patient Navigation+Diabetes Self-Management Support	0.88	± 1.62

Medication Refills Secondary · 6 months

Number of participants with 1 or more gaps in refilling oral diabetes medications during the study period. A gap is defined as not refilling prescription for 7 or more days after prescription has ran out.

Group	Value	95% CI
Patient Navigation	27
Patient Navigation+Diabetes Self-Management Support	20

Mean A1C Change Secondary · 6 months

Change in A1C from baseline to 6-month follow-up

Group	Value	95% CI
Patient Navigation	0.65	± 1.76
Patient Navigation+Diabetes Self-Management Support	0.72	± 1.88

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected over 6 months for each participant; 2 years total for the overall study period.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Patient Navigation

Serious: 7/54 (13%)

Deaths: 1/54

Patient Navigation+Diabetes Self-Management Support

Serious: 7/56 (13%)

Deaths: 1/56

Serious adverse events (2 terms)

Reaction	System	Patient Navigation	Patient Navigation+Diabete…
Hospitalizations	Endocrine disorders	—	—
Hypoglycemia	Endocrine disorders	—	—

Most-reported serious reactions: Hospitalizations, Hypoglycemia.

Data from ClinicalTrials.gov NCT03802825 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Bridge to Health/Puente a la Salud: a pilot randomized trial to address diabetes self-management and social needs among high-risk patients.
   Fitzpatrick SL, Papajorgji-Taylor D, Schneider JL, Lindberg N, et al · · 2022 · cited 8× · PMID 35849138 · DOI 10.1093/tbm/ibac016