Tackling 30-day Readmissions in Patients With Cirrhosis: The SALTYFOOD Trial

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT03493204

Collaborator

(none)

Enrollment

Location

Arms

15.8

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the feasibility of a home meal delivery program for patients with cirrhosis and ascites and to determine the effectiveness of a salt-restricted (2 gram sodium) meal delivery program in reducing the need for therapeutic paracenteses and/or all-cause re-admissions for these patients. Many patients with cirrhosis don't have enough nutrients in the body and are frail and these meals may help them maintain a good diet and lead to improved quality of life.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Encephalopathy Ascites Liver Diseases Cirrhosis	Other: Meal delivery Other: Standard pamphlet with Dietary Advice	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Tackling 30-day Readmissions in Patients With Cirrhosis: The SALTYFOOD Trial

Actual Study Start Date :

Apr 24, 2018

Actual Primary Completion Date :

Aug 19, 2019

Actual Study Completion Date :

Aug 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Home-delivered, salt restricted Meal description: salt-restricted (1500 mg to 2000 mg daily), > 2100 kilocalorie, high protein (>80 g daily) in addition to receiving standard pamphlet receipt	Other: Meal delivery The food will be pre-packaged for storage and patient will prepare these meals at home
Active Comparator: Dietary Advice Standard of care, advice on salt-restriction using standard pamphlet receipt	Other: Standard pamphlet with Dietary Advice Explains how to maintain a low-sodium diet

Arm

Intervention/Treatment

Experimental: Home-delivered, salt restricted

Meal description: salt-restricted (1500 mg to 2000 mg daily), > 2100 kilocalorie, high protein (>80 g daily) in addition to receiving standard pamphlet receipt

Other: Meal delivery

The food will be pre-packaged for storage and patient will prepare these meals at home

Active Comparator: Dietary Advice

Standard of care, advice on salt-restriction using standard pamphlet receipt

Other: Standard pamphlet with Dietary Advice

Explains how to maintain a low-sodium diet

Outcome Measures

Primary Outcome Measures

Number of therapeutic paracenteses [From date of randomization until 12 weeks]
Number of paracenteses

Secondary Outcome Measures

Change in Quality of life [baseline, week 12]
Measured by Ascites Symptom Inventory (ASI-7). This is a 7 question scale that measures the subject's symptoms with a value from 0-4 (0=does not apply / 4=very strong applies). The higher the subject's score the worse the subject's symptoms. The mean change will be compared between groups.

Other Outcome Measures

Number of hospital-bed days in 12 weeks [From date of randomization until 12 weeks]
The number of days the participants were hospitalized after randomization
Change in diuretic dose [baseline, week 12]
The dose amount changes the participant's medications that are considered diuretics
Change in frailty measures [baseline, week 12]
Change in the hand grip strength using a hand-held dynamometer. The device will be squeezed 3 times with their dominant hand and the force measured in kilograms. The best recorded value (highest force number) will be their value.
Change in frailty measures [baseline, week 12]
Change in time taken to walk 5 meters (walk speed measured in meters per second)
Quality of life [baseline, week 12]
Change in Visual Analog Scale. The subject selects how their health is today by marking an X on the scale from 0-100; 0= worst imaginable health state / 100= best imaginable health state

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult 18 years or older of age
Clinical diagnosis of cirrhosis with ascites. Diagnosis of cirrhosis will be based upon:

liver biopsy, OR
history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR
2 of the following 4 criteria: i. Ultrasound (US), computerized axial tomography (CT) or Magnetic Resonance Imaging (MRI) imaging findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites) ii. Fibroscan liver stiffness score >13 kPa iii. Laboratory testing: Aspartate Aminotransferase (AST)/platelet ratio index (APRI) >2.0 iv. CT, MRI or Esophagogastroduodenoscopy (EGD) showing presence of esophageal varices