Effectiveness of a nurse-led management intervention on systolic blood pressure among type 2 diabetes patients in Uganda: a cluster randomized trial

Abstract

Background Hypertension (HT) is an orchestrator of atherosclerotic cardiovascular disease (ASCVD) in persons living with type 2 Diabetes (T2D). Control of systolic blood pressure (SBP) and HT as a whole is suboptimal in diabetes partly due to scarcity of doctors. While nurse-led interventions are pragmatic and cost-effective in the control of HT in primary health care, their effectiveness on SBP control among patients with T2D in Uganda is scantly known. Aim We evaluated the effectiveness of a nurse-led management intervention on SBP among T2D patients with a high ASCVD risk in Uganda. Methods A two-armed cluster randomized controlled trial was conducted to compare the nurse-led management intervention with usual doctor-led care. The intervention involved training of nurses to provide structured health education, protocol based HT/CVD management, 24-hour phone calls and 2 monthly text messages for 6 months. The primary outcome was mean change in SBP between baseline and after 6 months. The secondary outcome was change in proportion of patients reaching treatment targets for SBP, total cholesterol (TC), fasting blood sugar (FBS), glycated hemoglobin (HbA1C), low density lipoprotein cholesterol (LDL), triglycerides (TG) and body mass index (BMI). The study was analyzed with intention to treat principle. Generalized estimating equations were used to assess for intra-cluster effect modifiers. Statistical significance was set at 0.05 for all analyses. Results Eight clinics (n = 388 patients) were included (intervention 4 clinics; n = 192, control 4 clinics; n = 196).A nurse-led intervention reduced SBP by 11.21 ± 16.02mmhg with a mean difference between the groups of -13.75mmHg (95% CI-16.48 to 11.02, P < 0.001).Diastolic blood pressure was reduced by 6.77 ± 9.48mmHg with a mean difference between groups of -7.17mmHg (95%C1 -8.87 to -5.48, p < 0.001). An increase in SBP of 2.53 ± 10.95mmhg was noted in the control group. The proportions of patients reaching target for SBP(95%CI -0.234 to 0.077,p < 0.001),diastolic blood pressure(95% CI-0.359 to 0.137,p < 0.001),LDL(95% -0.075 to 0.007,p < 0.001)and TGs(95% -0.0155 to 0.032,p = 0.002) increased while those of FBS (P = 0.66), HbA1c (P = 0.710) and BMI (P = 0.414) did not change. Conclusion A nurse-led management intervention reduces SBP and ASCVD risk among patients with T2D.Such an intervention may be pragmatic in screening and management of HT/ASCVD in Uganda. Trial Registration: Pan African Clinical Trial Registry, PACTR202001916873358, registered 6th October 2019.