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Evaluation of a Nutrition Education Guide for Patients With Cirrhosis

C

Centre hospitalier de l'Université de Montréal (CHUM)

Status

Completed

Conditions

Cirrhosis

Treatments

Behavioral: Nutrition in Cirrhosis guide

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

76 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • cirrhosis diagnosis documented by biopsy, radiological evidence, elastrography or decompensation event (such as hepatic encephalopathy, ascites and gastro-oesophageal bleeding)
  • having access to Internet

Exclusion criteria

  • non-french speaking

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

76 participants in 2 patient groups

Guide+
Experimental group
Description:
Participants who received and used the Nutrition in Cirrhosis guide
Treatment:
Behavioral: Nutrition in Cirrhosis guide
Guide-
No Intervention group
Description:
Participants who received standard of care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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