Impact of a Structured Multimodal Educational Program on Clinical Outcomes and Quality of Life in Patients With Critical Limb Ischemia: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Frequency of CLI-related hospitalizations
研究概览
简要总结
Critical limb ischemia (CLI) is a severe condition where poor blood flow to the legs causes pain, non-healing wounds, and may require amputation. It affects 10% of people over 40, rising to 20% in those over 70. Within the first year after diagnosis, 30% of patients need amputation and 25% die.
Current treatments include medications, surgery to restore blood flow, or amputation, but results remain poor. Research shows that lifestyle changes like quitting smoking and regular exercise can significantly improve outcomes, yet most CLI patients struggle to make these changes and lack knowledge about their condition.
This study tests whether a structured educational program called the "Critical Limb Ischemia School" can help patients. The program teaches patients about their condition, symptom management, lifestyle modifications, and when to seek medical help. The investigators will compare patients receiving this education to those getting standard care.
The study will evaluate several important health outcomes during a 12-month period to determine if the educational program makes a meaningful difference in patients' lives. The investigators will assess how the intervention affects patients' overall well-being, their ability to manage symptoms and daily activities, and whether it helps prevent serious complications that could lead to disability.
If successful, this program could provide a cost-effective way to help CLI patients manage their condition and potentially avoid serious complications like amputation.
详细描述
This randomized controlled trial evaluates the effectiveness of a structured multimodal educational program (School of Critical Limb Ischemia) compared to standard medical care in improving clinical outcomes for patients with critical limb ischemia (CLI).
Modifiable risk factors including smoking, physical inactivity, uncontrolled diabetes, hypertension, and dyslipidemia play crucial roles in disease progression. Research demonstrates that comprehensive risk factor modification significantly improves outcomes-patients who quit smoking have 14% five-year mortality compared to 31% among continued smokers. Despite this evidence, patient adherence remains low, with only 5-30% successfully quitting smoking and fewer than 50% engaging in recommended exercise programs.
Educational interventions have proven effective in other chronic conditions such as diabetes and heart failure, improving patient self-management and clinical outcomes. However, significant knowledge gaps exist among CLI patients-only 54% are aware of multiple treatment options, 24% incorrectly believe no additional treatment is needed after surgery, and only 31% understand the priority of conservative therapy over invasive interventions. This highlights the critical need for structured educational programs specifically designed for CLI patients.
The intervention combines traditional face-to-face education with digital technologies to create a personalized, accessible learning experience addressing disease understanding, risk factor modification, symptom recognition and management, and shared decision-making. The program utilizes interactive group sessions, individual counseling, digital platforms with multimedia materials, printed resources, peer support, and regular follow-up contact. Participants are randomly assigned to receive either the educational program plus standard medical care or standard medical care alone, with 12-month follow-up to assess both short-term and medium-term outcomes.
If successful, this research could transform CLI management by providing evidence for implementing structured educational programs in vascular surgery practices. Given the substantial economic burden of CLI treatment (estimated at USD 24,000-72,000 per patient in the first year), even modest improvements in clinical and economic outcomes could result in significant healthcare cost savings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Confirmed diagnosis of chronic critical limb ischemia (CLI)
- •Rutherford category 2-5
- •Ability to understand study procedures and provide signed and dated written informed consent
- •Fluency in Russian language
- •Access to telephone and internet
排除标准
- •Severe cognitive impairment
- •Participation in another clinical trial that might interfere with study outcomes
- •Planned major amputation within 3 months
- •Diabet 1 and 2 type
- •Inability to attend scheduled educational sessions
- •Severe visual or hearing impairments that would interfere with participation in educational sessions
- •Patients who declined to participate after being informed about the study protocol
研究组 & 干预措施
Educational Program + Standard Medical Care
Participants receive a comprehensive 4-week multimodal educational program including interactive group sessions, digital platform access, printed materials, and medical hotline access in addition to standard medical care.
干预措施: Structured Multimodal Educational Program for Critical Limb Ischemia (Other)
Standard Medical Care
Participants receive standard medical care for critical limb ischemia including routine vascular surgery consultation, standard medical management, and usual wound care instructions without any structured educational intervention.
干预措施: Standard medical care (Other)
结局指标
主要结局
Frequency of CLI-related hospitalizations
时间窗: 12 months from enrollment
Total number of hospitalizations related to critical limb ischemia or its complications (such as limb infections, need for revascularization, amputation) per patient during the follow-up period.
SF-12 Quality of Life Score
时间窗: Baseline, 6 months, and 12 months from enrollment
12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS): 0-100 Mental Component Summary (MCS): 0-100 Higher scores indicate better quality of life and better health status.
次要结局
- Visual Analog Scale (VAS) Pain Score(Baseline, 6 months, and 12 months from enrollment)
- Proportion of disability cases(12 months from enrollment)
- Smoking cessation rate(12 months from enrollment)
- Pain-free walking distance(Baseline, 12 months from enrollment)
- Quality-Adjusted Life Years (QALY)(12 months from enrollment)
研究者
Didar Khassenov
Head of department
Tulip Medicine