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Original Investigation
July 2017

Effect of a Community Health Worker Intervention Among Latinos With Poorly Controlled Type 2 DiabetesThe Miami Healthy Heart Initiative Randomized Clinical Trial

Author Affiliations
  • 1Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida
  • 2Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, Florida
  • 3Mrs Alonzo is no longer at the University of Miami.
  • 4now affiliated with Department of Medicine, George Washington University School of Medicine, Washington, DC
JAMA Intern Med. 2017;177(7):948-954. doi:10.1001/jamainternmed.2017.0926
Key Points

Question  Can a community health worker intervention improve outcomes among Latinos with poorly controlled type 2 diabetes?

Finding  In this randomized clinical trial of 300 Latino adults, a community health worker intervention resulted in modest improvements in hemoglobin A1c levels. The effect on systolic blood pressure varied and did not meet the preplanned target, and no changes in low-density lipoprotein cholesterol levels were observed.

Meaning  The community health worker intervention showed improvement in only 1 of the 3 preplanned primary outcomes.

Abstract

Importance  Community health worker (CHW) intervention is a promising approach to address type 2 diabetes among Latinos. However, evidence from randomized clinical studies is limited.

Objective  To compare a CHW intervention with enhanced usual care.

Design, Setting, and Participants  This 52-week, single-blind, randomized clinical trial included 300 Latino adults aged 18 to 65 years who were treated in 2 public hospital outpatient clinics in Miami-Dade County, Florida, from July 1, 2010, through October 31, 2013. Eligible participants had a hemoglobin A1c (HbA1c) level of 8.0 or greater. Follow-up was completed January 31, 2015, and data were analyzed from March 10, 2015, to June 6, 2016.

Interventions  A 1-year CHW intervention consisted of home visits, telephone calls, and group-level activities.

Main Outcomes and Measures  Primary outcomes included systolic blood pressure (SBP), low-density lipoprotein cholesterol (LDLC) levels, and HbA1c levels. Secondary outcomes included body mass index, medication regimen intensification, and self-reported measures of diet, physical activity, and medication regimen adherence.

Results  Of the 300 participants randomized (135 men [45%] and 165 women [55%]; mean [SD] age, 55.2 [7.0] years), we obtained follow-up data on 215 (71.7%). Participants in the CHW group received a median of 4 home visits and 20 telephone calls. After adjusting for baseline values and covariates, participants in the CHW group had an HbA1c level that was 0.51% lower (95% CI, −0.94% to −0.08%) than that of participants in the enhanced usual care group. The reduction in SBP of 4.62 mm Hg (95% CI, −9.01 to −0.24 mm Hg) did not meet the preplanned target of 8 mm Hg and was not statistically significant in unadjusted models. No significant differences in LDLC levels (mean difference, −8.2 mg/dL; 95% CI, −18.8 to 2.3 mg/dL) or any of the preplanned secondary outcomes were observed. Post hoc analyses suggest that the intervention may be more beneficial among those with worse control of their type 2 diabetes at baseline.

Conclusions and Relevance  Among Latinos with poorly controlled type 2 diabetes, a 12-month CHW intervention lowered HbA1c levels by 0.51%. The intervention did not lead to improvements in LDLC levels, and the findings with respect to SBP were variable and half of what was targeted. Future studies should examine whether CHW interventions affect other measures, such as access to health care or social determinants of health.

Trial Registration  clinicaltrials.gov Identifier: NCT01152957

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