A Randomized, Prospective Study of a Behaviorally-based Tailored Disease Management Intervention vs Control in Patients With Risk Factors for Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Change in FIB-4 score
研究概览
简要总结
To determine the effectiveness of a behaviorally-based tailored disease management intervention in patients with fibrosis or steatosis and risk factors for cirrhosis.
详细描述
Hypothesis
A technology-assisted self-management intervention that addresses diet, physical activity, alcohol use, and medication adherence can produce regression in fibrosis as measured by FIB-4 in patients with fibrosis or steatosis and risk factors for cirrhosis, including chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, alcohol use, or non-alcoholic fatty liver disease (NAFLD).
Primary objective:
To test the effect of the behavioral intervention on fibrosis in a randomized trial. We will randomize eligible HOPE Clinic patients to (i) a 6-month self-management intervention to help participants implement behavioral changes to manage their disease or (ii) a wait-list control group that will receive the intervention after their 6-month assessment.
Secondary objective:
Evaluate changes in behavioral risk factors for liver fibrosis or steatosis (body composition, physical activity, diet, medication adherence, alcohol use), metabolic syndrome, and patient activation and other behavioral determinants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •1. Evidence of steatosis (CAP score ≥ 290 by vibration controlled transient elastography) OR Evidence of liver fibrosis (FIB-4 index ≥ 1.6 or fibrosis grade ≥ F2 by vibration controlled transient elastography [F2 score ≥ 8kPa]) AND meets one of the following criteria: i. overweight or obese (BMI≥23 in Asians or BMI≥25 in other racial groups), OR ii. presence of type II diabetes mellitus, OR iii. lean/normal weight with presence of at least two metabolic risk abnormalities, OR:
- •Waist circumference ≥90/80 cm in Asians or ≥102/88 cm in other racial groups)
- •Blood pressure ≥130/85 mmHg or specific drug treatment
- •Plasma triglycerides ≥150 mg/dl or specific drug treatment
- •Plasma HDL-cholesterol <40 mg/dl for men and <50 mg/dl for women, or specific drug treatment
- •Prediabetes (fasting glucose levels 100-125 mg/dl , or HbA1c 5.7-6.4% ) iv. AUDIT-C ≥4 for men and ≥3 for women AND AUDIT-10 = 8-15
- •Evidence of liver fibrosis (FIB-4 index ≥ 1.6 or fibrosis grade ≥ F2 by vibration controlled transient elastography) and presence of one of the following:
- •chronic HBV (HBsAg+ or taking anti-HBV therapy), or
- •chronic HCV (
- •detectable HCV RNA > 4 months or a
- •history of HCV infection and taking anti-HCV therapy)
- •3. At least 18 years old
- •Speak and read English or Spanish
- •Access to smartphone with data plan or Wi-Fi access
- •Willing to receive up to 12 text messages per week
排除标准
- •Pregnant or planning to become pregnant in next 12 months (by self-report)
- •Medical contraindications to home-based exercise or low-fat, high-vegetable-and-fruit diet
- •Recent or planned surgery that would interfere with home-based exercise or a low-fat, high vegetable and fruit diet
- •Current or prior history of primary liver cancer or cancer that is metastatic to the liver
- •AUDIT-10 score >15
- •Family or household member already enrolled into study
研究组 & 干预措施
Arm 2: Delayed Intervention
participants will receive the intervention after the 6-month follow-up visit
干预措施: Control Group (Behavioral)
Arm 1: Immediate Intervention
participants will receive the 6 months intervention immediately
干预措施: Intervention Group (Behavioral)
结局指标
主要结局
Change in FIB-4 score
时间窗: up to 6 months
a serum-based biomarker of fibrosis
次要结局
未报告次要终点