Improving The Management Of Leprosy Ulcers Through A Community Self-Care Intervention Using A Stepped Wedge Cluster Randomised Trial In South-East Nigeria

BackgroundPeople with sensory neuropathy caused by leprosy suffer from recurrent ulcers. Self-care is used to promote ulcer healing and reduce recurrence. The challenge is to maximise use of self-care and to optimise the way it is practised. RedAid Nigeria in South-East Nigeria adapted and implemented a recently developed international guideline for self-care of ulcers in an area with a high prevalence of leprosy. We report a prospective evaluation of the effectiveness of this intervention in reducing the prevalence and severity of ulcers and in improving wellbeing. MethodsA mixed methods partial stepped wedge cluster randomized trial across 15 clinics serving patients affected by neuropathy and recurrent ulcers. Outcomes were number and area of ulcers, self-rated health and wellbeing. We used a Bayesian analysis to estimate treatment effects and a process analysis based on descriptive statistics and thematic analysis of qualitative data. ResultsThe ulcers at baseline were long-standing - mean (sd) of ulcer duration at baseline was 58.55 (94.49) months and total disability rate was high (65.99%). 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 (cm2) 1.12 (0.53 - 2.27). 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). 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. Improved wellbeing was described in terms of improved confidence in administering self-care and better integration in local communities. DiscussionThe intervention improved perceptions of health and wellbeing, despite having small and uncertain effects on ulcer-related outcomes. Effecting an improvement in ulcer size and number through a community intervention may be difficult to achieve in poor, rural contexts, even if patients respond positively to the intervention. Trial Registration: Retrospectively registered on the ISRCTN registry with trial registration number ISRCTN12572449 and can be viewed at: https://www.isrctn.com/ISRCTN12572449.