Nurse-led Continuum of Care for People With Diabetes and Pre-diabetes in Nepal (NUCOD): Study Protocol for a Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 1,236
- 主要终点
- Change in Glycated Hemoglobin (HbA1c) level
研究概览
简要总结
The study aims to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing standard diabetes program in Nepal.
详细描述
The purpose of this study will be to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing standard diabetes program in Nepal.
We will conduct a two-arm, open-masked stratified cluster randomized controlled trial of a NUrse-led COntinuum of care for people with diabetes and pre-diabetes (NUCOD), with primary care centers (Outreach centers and Government health posts) as a unit of randomization. NUCOD will be delivered through the trained diabetes nurses in the community to the intervention group and the outcomes will be compared to the enhanced usual-treatment group at 6 and 12 months of the intervention. The primary outcome will be change in glycated hemoglobin (HbA1c) level among diabetes and progression to type 2 diabetes among pre-diabetes, and implementation outcomes measured using the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. Outcomes will be analyzed on an intention to treat basis.
The results of this trial will provide information about the effectiveness of the NUCOD program in improving clinical outcomes for diabetes and pre-diabetes individuals, and implementation outcomes for the organization.
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
- Double (Care Provider, 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
- 是
入选标准
- •with confirmed pre-existing type II diabetes and prediabetes at the time of our screening (i.e., pre-existing diabetes or prediabetes)
- •with confirmed diagnosis of type II diabetes or prediabetes after our community screening process (i.e., newly diagnosed diabetes and prediabetes)
- •is not planning to relocate outside of the current place of living in next 2 years
- •is older than 18 years of age
排除标准
- •are not psychologically capable of communication
- •are diagnosed as type 1 diabetes
研究组 & 干预措施
Continuum of care
Trained diabetes nurses will provide continuum of care to the participants that includes: conducting community awareness campaigns, screening programs, linkage to clinical care, community follow-up counseling and support for individuals with diabetes, and prevention programs for individuals with pre-diabetes.
干预措施: Nurse-led Continuum of Care (Behavioral)
Usual care
The control group will receive usual diabetic care without the nurse coordination and supervision as in the intervention group.
干预措施: Nurse-led Continuum of Care (Behavioral)
结局指标
主要结局
Change in Glycated Hemoglobin (HbA1c) level
时间窗: Baseline, 6 months, 12 months
The HbA1c will be measured using Boronate affinity chromatography (Axis-Shield, Norway)
Change in the incidence of diabetes among individuals with pre-diabetes
时间窗: 6 months, 12 months
Electronic Health Record will be used to measure the incidence of diabetes
次要结局
- Change in the "Adoption at the patient level" measured by the Diabetes Treatment Satisfaction Questionnaire(Baseline, 6 months, 12 months)
- Change in the "Adoption at the patient level" measured by the Summary of Diabetes Self-Care Activities Scale(Baseline, 6 months, 12 months)
- Change in Blood Pressure(Baseline, 6 months, 12 months)
- Change in lipid profile levels (HDL, LDL, Triglycerides, Total cholesterol)(Baseline, 6 months, 12 months)
- Change in the "Reach" of people participating in the program(6 months, 12 months)
- Change in the "Adoption at the clinic level"(6 months, 12 months)
- Change in Body Mass Index(Baseline, 6 months, 12 months)
研究者
Biraj Man Karmacharya
Associate Professor
Kathmandu University School of Medical Sciences