Evaluation of a Nutrition Education Guide for Patients With Chronic Liver Disease: Impact on the Patient and Caregiver
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Nutritional knowledge
研究概览
简要总结
The goal of this prospective study is to evaluate the impact of the Nutrition in Cirrhosis guide in patients with chronic liver disease. Researchers compared the patients who received the Guide (Guide+ group) to the patients who received standard of care (Guide- group). Data collection occured at baseline, 3 and 6 months, and included evaluation of nutrition knowledge (questionnaire based on the Guide), quality of life (Chronic Liver Disease Questionnaire) and nutritional risk (Liver Disease Undernutrition Screening Tool). Satisfaction was evaluated with 3 focus groups including patients from the Guide+ group as well as a patient partner and thematic analysis was conducted.
详细描述
In this study, the investigators aimed to evaluate the impact of the Nutrition in Cirrhosis guide, an evidence-based educational resource created by a team of experts in Canada. The Guide was conceived in order to inform patients and help them follow nutritional guidelines for cirrhosis, which has been shown to be a challenge. Specifically, this study aimed to evaluate the impact of the Guide on patients' nutritional knowledge, quality of life and nutritional risk over a 6-month period, as well as changes in dietary intake. Secondly, the goal was to evaluate patients' satisfaction of the Guide using focus groups. In this randomized controlled mixed-methods study conducted at the Centre Hospitalier de l'Université de Montréal Research Center, patients in the intervention group (Guide+) received and used the Guide for 6 months, and a control group (Guide-) received standard of care. Data was collected at baseline, 3 months and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •cirrhosis diagnosis documented by biopsy, radiological evidence, elastrography or decompensation event (such as hepatic encephalopathy, ascites and gastro-oesophageal bleeding)
- •having access to Internet
排除标准
- •non-french speaking
研究组 & 干预措施
Guide+
Participants who received and used the Nutrition in Cirrhosis guide
干预措施: Nutrition in Cirrhosis guide (Behavioral)
Guide-
Participants who received standard of care
结局指标
主要结局
Nutritional knowledge
时间窗: From enrollment to the end of intervention at 6 months
The assessment of participants' nutritional knowledge was conducted using a questionnaire created by experts from the research team with the intent to be solely based on the chapters of the Guide. The questionnaire consists of 14 items related to nutritional recommendations (dietary intake, protein, sodium, etc.), as well as questions regarding nutritional choices in the context of cirrhosis, definitions of nutritional terms, food groups and nutrients.
次要结局
- Satisfaction with the Guide(At the end of the 6-month intervention)
- Health-related quality of life(From enrollment to the end of intervention at 6 months)
- Nutritional risk(From enrollment to the end of intervention at 6 months)
- Dietary intakes(From enrollment to the end of intervention at 6 months)
- Health-related quality of life(From enrollment to the end of intervention at 6 months)
- Nutritional risk(From enrollment to the end of intervention at 6 months)
- Dietary intakes(From enrollment to the end of intervention at 6 months)
- Satisfaction with the Guide(At the end of the 6-month intervention)