Improving the management of leprosy ulcers through a community self-care intervention using a stepped wedge cluster randomised trial in South-East Nigeria

Background Self-care is used to promote leprosy ulcer healing and reduce recurrence. RedAid Nigeria in South-East Nigeria adapted and implemented a recently developed international guideline for self-care of leprosy ulcers. We report a prospective, mixed methods evaluation of this intervention and in improving wellbeing. Methods A mixed methods partial stepped wedge cluster randomized trial across 15 clinics serving 148 patients affected by neuropathy and recurrent ulcers. Outcomes were number self-rated health and wellbeing and area of ulcers. We used a Bayesian analysis to estimate treatment effects and a process analysis based on descriptive statistics and thematic analysis of qualitative data. Results The ulcers were long-standing – mean (sd) 58.55 (94.49) months and total disability rate was high (65.99%). There was evidence of an increase in self-reported health and wellbeing associated with the intervention (EQ-5D VAS mean difference 10.93 (8.60, 13.23) out of 100; life satisfaction 1.18 (0.65, 1.72) out of 10). There was no evidence of an intervention effect on the persistence of ulcers (OR: 1.00 (95% credible interval (CrI) 0.29–3.56) or relative area of ulcers (cm 2 ) 1.12 (0.53–2.27). Process data indicate the intervention was delivered as planned. Qualitative data triangulated with quantitative data findings suggest enthusiasm among participants for and adherence to the intervention. Discussion The intervention improved perceptions of health and wellbeing, despite having small and uncertain effects on ulcer-related outcomes. Trial Registration: Retrospectively registered on 18.08.2022 on the ISRCTN registry with trial registration number ISRCTN12572449 and can be viewed at: https://www.isrctn.com/ISRCTN12572449.