糖尿病患者の黒人成人を対象とした文化的に調整されたピアサポート介入の付加価値の調査：ランダム化混合法パイロットトライアル

This randomized controlled mixed methods pilot study evaluated the preliminary signal of effectiveness of a culturally tailored intervention embedded within a standard Diabetes Self-Management Education (DSME) program.

Fourteen Black adults with uncontrolled diabetes (A1C ≥ 7.5) enrolled in the study. The study was conducted at a community center and over the phone within a US Midwestern State. All participants participated in a 6-week evidence-based DSME program, with a subset of participants (n=7) randomized to the intervention receiving additional education sessions and race-congruent phone-based peer support throughout the 6-month intervention. Changes in Hemoglobin A1c (A1C) (primary outcome) and self-reported medication adherence (secondary outcome), and other psychosocial outcomes (beliefs about diabetes, self-efficacy, diabetes empowerment, etc.) were assessed at 3 and 6 months using paired t-tests. Between-group differences were analyzed using the Mann-Whitney U-test and within-group differences were analyzed using Wilcoxon signed-rank test. Qualitative data on participant's perceived impact of the intervention on primary and secondary outcomes were collected through semi-structured interviews and analyzed to identify themes. Subsequently, a mixed methods analysis was conducted to compare quantitative and qualitative findings.

At 6-months, A1C was statistically significantly lower in the intervention group (7.9% (SD =0.4; 95% CI [7.6-8.2]); n=7) compared to the control group (10.6% (SD =0.7; 95% CI [9.9-11.2]); p =0.01; d=0.73; n = 6). There were no significant between-group differences (p =0.22) in medication adherence between the 2 groups. Qualitative themes related to beliefs about medicines, diabetes distress, etc. were identified, and integrated with quantitative psychosocial outcomes further explaining the findings.

The findings suggest a signal of evidence for a future adequately powered, randomized controlled trial, testing whether the addition of the theory and evidence-informed culturally specific components of the intervention improve outcomes compared to the DSME program alone.