Design and rationale of a randomized-controlled trial of home-delivered meals for the management of symptomatic ascites: the SALTYFOOD trial.

ABSTRACT:

Background

When patients with cirrhosis develop ascites, it is associated with sharply increased mortality and healthcare utilization with decreased quality of life. Dietary salt restriction is first-line therapy for ascites but it is limited by poor adherence.

Methods

We will recruit 40 patients with cirrhosis and ascites who have received a recent paracentesis or hospitalization for a 1:1 randomized trial of standard care (education on salt restriction) versus home-delivered meals. Our primary outcome is the number of paracenteses needed over 12 weeks. Secondary outcomes include hospital-bed days, health-related quality of life (HRQOL, Ascites Symptom Inventory-7 and Visual Analogue Scale) and performance on batteries of physical function including hand grip (kg) and walk

SUBMITTER: Tapper EB 

PROVIDER: S-EPMC6454849 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature