The Impact of the Self-efficacy Building Nursing Program on Foot Self-care Confidence and Perceived Risk of Diabetes-related Foot Complications Among Diabetic Elderly Patients: A Randomized Virtual Based Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Foot Care Scale for Older Diabetics
研究概览
简要总结
Abstract
Background:
Diabetes-related foot complications are a major cause of morbidity among elderly patients with diabetes, often exacerbated by inadequate self-care practices and low self-efficacy. Innovative, accessible interventions are urgently needed to empower patients in preventive foot care.
Objective:
This study aimed to evaluate the impact of a self-efficacy building nursing program, delivered virtually, on foot self-care confidence and perceived risk of foot complications among elderly diabetic patients.
Methods:
A randomized controlled trial will be conducted with 120 elderly diabetic patients recruited from at the diabetic outpatient clinics at Damanhour City of El-Behaira Governorate, Egypt. Participants will be randomly assigned to either an intervention group (60 participants) receiving the virtual self-efficacy building program or a control group ( 60 participants) receiving no interventions.
Outcomes Evaluation:
Outcomes will be measured at baseline (pretest), and immediately post-interventions (Posttest) using validated scales.
Keywords Self-efficacy, Foot self-care, Diabetes-related foot complications, Elderly patients, Virtual nursing intervention, randomized controlled trial
详细描述
Objectives:
Primary Objective:
• To evaluate the effectiveness of a self-efficacy building nursing program on improving foot self-care confidence among elderly diabetic patients.
Secondary Objectives:
- To assess the impact of the self-efficacy building program on reducing the perceived risk of diabetes-related foot complications among elderly diabetic patients.
- To compare changes in foot self-care confidence and perceived risk between the intervention group and the control group over time (baseline, post-intervention, and 3-month follow-up).
- To determine the feasibility and acceptability of delivering a self-efficacy-based nursing intervention through a virtual platform to elderly diabetic patients.
- To explore the relationship between improvements in foot self-care confidence and reductions in perceived risk of foot complications following the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Adults aged 60 years and above.
- •Diagnosed with type 2 diabetes for at least one year.
- •Able to use a smartphone or device with internet access.
- •Willing to participate in a virtual education program.
- •No current foot ulcers or advanced diabetic foot complications.
排除标准
- •Cognitive impairment or psychiatric illness affecting comprehension.
- •Severe visual or hearing impairments preventing participation.
- •Participation in another educational or foot care intervention study within the past six months.
- •Exclusion Criteria:
研究组 & 干预措施
Usual care
Control Group Participants in the control group will receive routine diabetes care as provided by the clinic, which may include brief verbal advice about foot care but no structured educational content or follow-up.
Intervention
Intervention Description
The Self-Efficacy Building Nursing Program is a structured, theory-based educational intervention grounded in Bandura's Self-Efficacy Theory. It aims to enhance participants' confidence in their ability to perform daily foot self-care behaviors and perceive their risk of complications accurately. The content includes:
Educational modules on diabetes and foot health.
Training on daily foot inspection, hygiene, nail and skin care, and appropriate footwear.
Motivational strategies, goal setting, and problem-solving skills.
Video demonstrations, live discussions, and Q&A sessions with a diabetes nurse educator.
The program will be delivered over four weekly virtual sessions, each lasting approximately 45-60 minutes, via a user-friendly telehealth platform (e.g., Zoom or WhatsApp Video). Follow-up support and reminders will be provided through weekly text messages and phone check-ins.
干预措施: The Self-Efficacy Building Nursing Program (Behavioral)
结局指标
主要结局
Foot Care Scale for Older Diabetics
时间窗: through study completion, an average of 1 year
The Foot Care Scale for Older Diabetics (FCSOD) is a validated tool designed to assess foot self-care behaviors, confidence in performing foot care, and perceived risk of diabetes-related foot complications among elderly diabetic patients. It covers key areas such as daily foot inspection, hygiene, nail and skin care, footwear practices, and professional care seeking. Items are typically rated on a Likert scale, with higher scores indicating better self-care practices and greater confidence. The FCSOD has demonstrated strong reliability and validity, making it a valuable instrument for both clinical assessments and research studies aimed at improving foot health outcomes in older adults. Its user-friendly format also makes it suitable for elderly populations, whether self-administered or conducted via interviews.
次要结局
- Foot Care Confidence Scale (FCCS)(through study completion, an average of 1 year)
研究者
Ahmed Hashem El-Monshed
Department of Psychiatric and Mental Health Nursing, Faculty of Nursing-Mansoura University, Egypt
Mansoura University