Original and modified version of intervention.

ObjectiveAfrica presents a higher diabetic foot ulcer prevalence estimate of 7.2% against global figures of 6.3%. Engaging family members in self-care education interventions has been shown to be effective at preventing diabetes-related foot ulcers. This study culturally adapted and tested the feasibility and acceptability of an evidence-based footcare family intervention in Ghana.MethodsThe initial phase of the study involved stakeholder engagement, comprising Patient Public Involvement activities and interviews with key informant nurses and people with diabetes (N = 15). In the second phase, adults at risk of diabetes-related foot ulcers and nominated caregivers (N = 50 dyads) participated in an individually randomised feasibility trial of the adapted intervention (N = 25) compared to usual care (N = 25). The study aimed to assess feasibility outcomes and to identify efficacy signals on clinical outcomes at 12 weeks post randomisation. Patient reported outcomes were foot care behaviour, foot self-care efficacy, diabetes knowledge and caregiver diabetes distress.ResultsAdjustments were made to the evidence-based intervention to reflect the literacy, information needs and preferences of stakeholders and to develop a context appropriate diabetic foot self-care intervention. A feasibility trial was then conducted which met all recruitment, retention, data quality and randomisation progression criteria. At 12 weeks post randomisation, efficacy signals favoured the intervention group on improved footcare behaviour, foot self-care efficacy, diabetes knowledge and reduced diabetes distress. Future implementation issues to consider include the staff resources needed to deliver the intervention, family members availability to attend in-person sessions and consideration of remote intervention delivery.ConclusionA contextual family-oriented foot self-care education intervention is feasible, acceptable, and may improve knowledge and self-care with the potential to decrease diabetes-related complications. The education intervention is a strategic approach to improving diabetes care and prevention of foot disease, especially in settings with limited diabetes care resources. Future research will investigate the possibility of remote delivery to better meet patient and staff needs.Trial registrationPan African Clinical Trials Registry (PACTR) ‐ PACTR202201708421484: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=19363 or pactr.samrc.ac.za/Search.aspx.ObjectiveAfrica提出的糖尿病足溃疡（diabetic foot ulcer）患病率估算值为7.2%，高于全球6.3%的平均水平。已有研究证实，让家属参与自我护理教育干预可有效预防糖尿病相关足溃疡。本研究在加纳地区对一项基于证据的足部护理家庭干预方案进行了文化适配，并检验其可行性与可接受性。 方法 本研究初始阶段开展利益相关方参与工作，包括患者公众参与活动，以及对关键知情护士与糖尿病患者的访谈（N=15）。第二阶段，共50对存在糖尿病相关足溃疡风险的成人及指定照护者参与了一项个体化随机可行性试验：其中25对接受适配后的干预方案（干预组），另外25对接受常规护理（对照组）。本研究旨在评估可行性结局，并于随机分组后12周时识别临床结局的疗效信号。患者报告结局指标包括足部护理行为、足部自我护理效能、糖尿病知识水平，以及照护者的糖尿病困扰程度。 结果 研究团队对原基于证据的干预方案进行了调整，以契合当地利益相关方的识字水平、信息需求与偏好，开发出适配本地情境的糖尿病足自我护理干预方案。随后开展的可行性试验满足了所有招募、受试者保留、数据质量及随机化推进标准。随机分组后12周时，干预组在改善足部护理行为、提升足部自我护理效能、增加糖尿病知识水平及降低糖尿病困扰程度方面均呈现出正向疗效信号。 未来实施该干预方案时需考量的问题包括：开展干预所需的医护人员资源、家属参与线下课程的可获得性，以及远程干预实施的可行性。 结论 适配本地情境的家庭导向型足部自我护理教育干预方案具备可行性与可接受性，或可提升患者的知识水平与自我护理能力，有望降低糖尿病相关并发症的发生风险。该教育干预是改善糖尿病护理与足部疾病预防的策略性方案，尤其适用于糖尿病护理资源有限的地区。未来研究将探索远程实施该方案的可能性，以更好地满足患者与医护人员的需求。 试验注册 泛非临床试验注册库（Pan African Clinical Trials Registry, PACTR） - PACTR202201708421484：https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=19363 或 pactr.samrc.ac.za/Search.aspx。