Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Effectiveness of CARE-D-Foot-Nav: 20-week wound healing with complete re-epithelialization of the wound
研究概览
简要总结
The purpose of this interventional study is to assess the effectiveness of CARE-D-Foot, a patient navigator intervention, as compared to usual care, on 20-week diabetic foot ulcer healing.
The study will further:
- Evaluate fidelity to and acceptability of the CARE-D-Foot-Nav program using mixed methods
- Perform a CARE-D-Foot-Nav cost-effectiveness analysis (CEA)
详细描述
The CARE-D-Foot-Nav (Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation) study is a randomized controlled trial testing whether a patient navigator-led intervention can improve healing outcomes for patients hospitalized with diabetic foot ulcers (DFUs). DFUs are a serious complication of diabetes that contribute to over 100,000 amputations annually in the U.S. and account for a significant portion of diabetes-related healthcare costs. Healing requires complex, multidisciplinary care focused on glycemic control, wound management, vascular disease treatment, and infection therapy. However, many patients, especially underserved populations such as non-Hispanic Black and Hispanic individuals, face barriers related to social determinants of health that hinder access to this care.
In this trial, 270 patients hospitalized with DFUs will be randomized to receive either usual care or participate in the CARE-D-Foot-Nav program for 20 weeks after hospital discharge. Participants in the intervention group will receive weekly support from a certified diabetes educator acting as a patient navigator, who will provide personalized care coordination, diabetes education, transportation assistance, and help connecting patients to medical and social resources.
Navigators have proven effective in improving outcomes for other chronic diseases by overcoming healthcare system and patient-level barriers, but no prior randomized trials have tested their impact on DFU care specifically. This study aims to fill that gap by evaluating whether the CARE-D-Foot-Nav program improves DFU healing rates, enhances patient engagement, and can be implemented cost-effectively. The intervention is designed to be scalable and focused on reducing healthcare disparities to help curb the diabetes-related amputation epidemic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Adults with diabetes admitted for any reason who have a full-thickness DFU (defined as a wound below the ankle through the dermis) or undergo a single toe amputation
- •History of prior amputations and DFUs of any severity
排除标准
- •Adults unable to understand the nature and scope of the study, enrolled in another clinical trial, or planned for discharge to an acute or long-term care facility,
- •Patients who undergo amputation of two or more toes during hospitalization and/or have a Society for Vascular Surgery Wound, Ischemia, foot Infection grade 4
研究组 & 干预措施
Standard of Care
Following discharge, the team will conduct research retention phone calls at 4, 8, 12, 16, and 20 weeks to review resource utilization over the past month.
Participants will have access to hospital and community resources available to all patients treated within the healthcare system.
Other resources may include, but are not limited to, social worker assistance with transportation, diabetes education (with referral by medical provider), nutritional support through Grady's "Food as Medicine Program", and interpreter services
干预措施: Standard of care (Other)
CARE-D-Foot-Nav
Participants in this arm will be assigned a dedicated DFU patient navigator The navigators will conduct 30-to 60-minute encounters, either by phone or in person, at least once a week during the 20-week program.
Participants can call the navigator with DFU-related concerns during the navigator's working hours.
干预措施: CARE-D-Foot-Nav (Other)
结局指标
主要结局
Effectiveness of CARE-D-Foot-Nav: 20-week wound healing with complete re-epithelialization of the wound
时间窗: Baseline, Week 20 (day 140 +/- 7 days)
Pictures will be taken at baseline and week 20 and compared by two different reviewers. The number of participants with complete wound healing will be reported.
次要结局
- Number of participants with confirmed wound healing(Baseline, week 22)
- DFU care clinic attendance(Within 14 and 30 days post hospital discharge)
- Wound area reduction(Baseline, Week 20)
- Major amputation(Baseline, Week 20)
- Number of deaths(Baseline, Week 20)
- EuroQol five-dimensional (EQ-5D) score(Baseline, Week 20)
- Glycemic control: Change in HbA1c(Baseline, Week 20)
- Perceived social support: Interpersonal Support Evaluation List-12(Baseline, Week 20)
- Medical mistrust: Change in the Trust in Physicians Scale(Baseline, Week 20)
- Tobacco cessation(Baseline, Week 20)
- Acute care utilization(After hospital discharge (up to 20 weeks))
- Services accessed(Baseline, Week 20)
- Peer support group attendance(Baseline, Week 20)
- Diabetic foot ulcer - short form (DFS-SF) score(Baseline, 20 weeks)
- Patient Health Questionnaire-2 (PHQ-2)(Baseline, 20 weeks)
- Patient Health Questionnaire-9 (PHQ-9)(Baseline, 20 weeks)
- Food insecurity(Baseline, Week 20)
- Housing stability(Baseline, Week 20)
- Financial resource strain questionnaire(Baseline, Week 20)
- Transportation needs(Baseline, Week 20)
研究者
Marcos C. Schechter
Associate Professor
Emory University