Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, United Kingdom.
Department of Nursing and Midwifery, Presbyterian University, Agogo, Ghana.
PLoS One. 2024 May 8;19(5):e0302385. doi: 10.1371/journal.pone.0302385. eCollection 2024.
Africa 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.
The 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.
Adjustments 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.
A 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.
Pan African Clinical Trials Registry (PACTR) - PACTR202201708421484: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=19363 or pactr.samrc.ac.za/Search.aspx.
非洲的糖尿病足溃疡患病率估计为 7.2%，高于全球的 6.3%。事实证明，让家庭成员参与自我护理教育干预可以有效预防糖尿病相关的足部溃疡。本研究对加纳基于证据的足部保健家庭干预措施进行了文化适应性改编和可行性及可接受性测试。
研究的初始阶段涉及利益攸关方的参与，包括患者公众参与活动和对关键信息护士和糖尿病患者（N=15）的访谈。在第二阶段，有发生糖尿病相关足部溃疡风险的成年人和指定的照顾者（N=50 对）参加了改编干预措施（N=25）与常规护理（N=25）的随机可行性试验。该研究旨在评估可行性结果，并在随机分组后 12 周评估临床结果的疗效信号。患者报告的结果为足部护理行为、足部自我护理效能、糖尿病知识和照顾者的糖尿病困扰。
对基于证据的干预措施进行了调整，以反映利益攸关方的文化水平、信息需求和偏好，并制定了适合国情的糖尿病足部自我护理干预措施。然后进行了一项可行性试验，该试验满足了所有的招募、保留、数据质量和随机分组进展标准。在随机分组后 12 周，疗效信号有利于干预组，表现为改善了足部护理行为、足部自我护理效能、糖尿病知识和降低了糖尿病困扰。未来需要考虑的实施问题包括提供干预措施所需的人员资源、家庭成员参加面对面课程的可用性以及考虑远程干预交付。
以家庭为导向的足部自我护理教育干预措施是可行的、可接受的，并且可能会提高知识和自我护理水平，从而降低糖尿病相关并发症的风险。该教育干预措施是改善糖尿病护理和预防足部疾病的一种策略，特别是在糖尿病护理资源有限的环境中。未来的研究将探讨远程交付的可能性，以更好地满足患者和工作人员的需求。
泛非临床试验注册中心（PACTR）-PACTR202201708421484：https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=19363 或 pactr.samrc.ac.za/Search.aspx。
