Sidekick Health Digital Solution (SK-241) for Individuals With Non Alcoholic Fatty Liver Disease (NAFLD): A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Acceptability and feasibility of the digital program (SK-241) - retention.
研究概览
简要总结
Sidekick Health has developed a digital behavioral change program (SK-241) specifically designed for people with metabolic derangements and non-alcoholic fatty liver disease (NAFLD). The SK-241 is delivered through a mobile application and aims at improving lifestyle and health outcomes by focusing on improving diet, increasing activity levels and reducing stress. In this study, the feasibility of the newly developed digital behavioral change program (SK-241) will be evaluated in a minimum of 30 individuals with a NAFLD diagnosis. The primary aim is to explore the acceptability of the SK-241 program by its users, in addition to exploring changes in clinical outcomes and medication adherence after a 12-week intervention with 6 months follow up.
详细描述
Non-alcoholic fatty liver disease (NAFLD) is an umbrella term used to describe a spectrum of liver pathology, characterized by >5% fat accumulation in the liver (steatosis), among people who drink little or no alcohol. Both genetic and lifestyle-related factors contribute to the pathogenesis of NAFLD. It is strongly associated with metabolic derangements, obesity, insulin resistance and type 2 diabetes mellitus. NAFLD is considered the liver manifestation of metabolic syndrome.
NAFLD can progress from a simple steatosis to a more severe and progressive condition, referred to as non-alcoholic steatohepatitis (NASH), which is characterized by additional liver inflammation and hepatocyte injury with or without fibrosis. In general, 20% of NAFLD patients are believed to progress to NASH.
Finding convenient and effective ways to incorporate lifestyle changes into daily lives of people with NAFLD and NASH is important. Sidekick Health has developed a digital behavioral change program (SK-241) for NAFLD and NASH patients consisting of an interactive mobile application.
The aim of this study is primarily to assess the acceptability and feasibility of adding a digital lifestyle intervention (SK-241) to the standard of care (SoC) for NAFLD patients, by assessing participants engagement, retention and satisfaction with the SK-241 program in a minimum of 30 individuals with a NAFLD diagnosis. In addition, the clinical effectiveness of the program will be explored. A minimum of 30 individuals with a NAFLD diagnosis will be included for a 12-week intervention with 6 months follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with a NAFLD diagnosis, defined as:
- •Confirmed liver steatosis >5%, with a FibroScan CAP cutoff score of > 294 decibel (dB)/m among individuals with one or more of the following: Type 2 diabetes OR BMI>30 OR Metabolic syndrome OR Previous diagnosis of NAFLD within the last 12 months
- •for individuals with type 2 diabetes: Stable dose of antidiabetic medication the last 90 days before screening (metformin, glitazones, glucagon like peptide-1 (GLP-1) analogues, sodium-glucose co transporter-2 (SGLT-2) inhibitor, sulfonylurea, insulin)
- •Capacity to give informed consent and understands verbal and written Icelandic
- •Owns and knows how to operate a smartphone
- •Willing and able to comply with the study intervention, all scheduled visits and procedures
排除标准
- •Insulin use
- •Known or self-reported cirrhosis
- •Alcohol consumption over 14 units/week for males, 7 units/week for women
- •Self-reported Hepatitis B (HepB), Hepatitis C (HepC), human immunodeficiency virus (HIV), or autoimmune hepatitis
- •Vitamin E intake of > 400 IU/day - unless stable for 12 weeks prior to baseline
- •Taking medications associated with liver steatosis; steroids, methotrexate, tamoxifen, amiodarone, tetracycline, valproic acid
- •Self-reported pregnancy
- •Participation in a weight loss program
- •History of, or any existing medical condition (e.g., ongoing cancer treatment, severe cardiopulmonary- or musculoskeletal disease, stroke, or myocardial infarction in the last 6 months) that, in the opinion of the investigator, would interfere with evaluation of the study intervention or affect the interpretation of the results of the study
结局指标
主要结局
Acceptability and feasibility of the digital program (SK-241) - retention.
时间窗: 12 weeks
Assess retention by percentage of users that complete the SK-241 program at week 12. 'Complete the program' is defined as finishing 75% of the program.
Acceptability and feasibility of the digital program (SK-241) - engagement.
时间窗: 12 weeks
Assess engagement by percentage of users that are active in the SK-241 program during the 12 weeks. 'Active' is defined as visiting the application at least once per week.
Acceptability and feasibility of the digital program (SK-241) - satisfaction.
时间窗: 12 weeks
Assess satisfaction based on the scores in the 18-item mobile health (mHealth) App Usability Questionnaire at week 12. Answers are scored on a 7-point Likert scale (ranging from 1 for "strongly disagree"to 7 "strongly agree") and total scores range from 18 to 126. The higher the score, the better the usability.
次要结局
- The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on fasting glucose.(9 months)
- The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on liver function.(9 months)
- The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on cholesterol.(9 months)
- The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on the cardiovascular risk factor activity level.(9 months)
- The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on body composition.(9 months)
- The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on HbA1c.(9 months)
- The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on hs-CRP.(9 months)
- The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on fasting insulin.(9 months)
- The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on liver fat content.(9 months)
- The feasibility of adding a digital program (SK-241) to standard of care, by assessing health related quality of life (HRQoL)(9 months)
- The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on weightloss.(9 months)
- The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on the cardiovascular risk factor blood pressure(9 months)
- The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on the cardiovascular risk factor waist circumference.(9 months)
- The feasibility of adding a digital program (SK-241) to standard of care, by assessing mental health.(9 months)
- The feasibility of adding a digital program (SK-241) to standard of care, by assessing medication adherence.(9 months)