Clinical Trials Directory

Trials / Completed

CompletedNCT07090447

Evaluation of a Nutrition Education Guide for Patients With Cirrhosis

Evaluation of a Nutrition Education Guide for Patients With Chronic Liver Disease: Impact on the Patient and Caregiver

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
76 (actual)
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALNutrition in Cirrhosis guidePatients in the intervention group received a paper copy of the Nutrition in Cirrhosis guide and were instructed to read and use it over the 6 months study period. The Nutrition in Cirrhosis guide consists 7 chapters, namely: Chapter 1: Malnutrition - What is it and why is it so important?; Chapter 2: What should patients eat and what to avoid?; Chapter 3: Tips for when patients do not feel like eating; Chapter 4: Recipe list; Chapter 5: Using meal supplements; Chapter 6: Managing weight loss and cirrhosis; Chapter 7: What to expect in the hospital.

Timeline

Start date
2021-02-04
Primary completion
2024-11-13
Completion
2024-11-13
First posted
2025-07-29
Last updated
2025-08-01

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT07090447. Inclusion in this directory is not an endorsement.