RESUMO
OBJECTIVES: To evaluate the effect of a practice-based, culturally appropriate patient education intervention on blood pressure (BP) and treatment adherence among patients of African origin with uncontrolled hypertension. METHODS: Cluster randomised trial involving four Dutch primary care centres and 146 patients (intervention n=75, control n=71), who met the following inclusion criteria: self-identified Surinamese or Ghanaian; ≥ 20 years; treated for hypertension; SBP ≥ 140 mmHg. All patients received usual hypertension care. The intervention-group was also offered three nurse-led, culturally appropriate hypertension education sessions. BP was assessed with Omron 705-IT and treatment adherence with lifestyle- and medication adherence scales. RESULTS: 139 patients (95%) completed the study (intervention n=71, control n=68). Baseline characteristics were largely similar for both groups. At six months, we observed a SBP reduction of ≥ 10 mmHg -primary outcome- in 48% of the intervention group and 43% of the control group. When adjusted for pre-specified covariates age, sex, hypertension duration, education, baseline measurement and clustering effect, the between-group difference was not significant (OR; 0.42; 95% CI: 0.11 to 1.54; P=0.19). At six months, the mean SBP/DBD had dropped by 10/5.7 (SD 14.3/9.2)mmHg in the intervention group and by 6.3/1.7 (SD 13.4/8.6)mmHg in the control group. After adjustment, between-group differences in SBP and DBP reduction were -1.69 mmHg (95% CI: -6.01 to 2.62, P=0.44) and -3.01 mmHg (-5.73 to -0.30, P=0.03) in favour of the intervention group. Mean scores for adherence to lifestyle recommendations increased in the intervention group, but decreased in the control group. Mean medication adherence scores improved slightly in both groups. After adjustment, the between-group difference for adherence to lifestyle recommendations was 0.34 (0.12 to 0.55; P=0.003). For medication adherence it was -0.09 (-0.65 to 0.46; P=0.74). CONCLUSION: This intervention led to significant improvements in DBP and adherence to lifestyle recommendations, supporting the need for culturally appropriate hypertension care. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN35675524.