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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-delivered, salt restricted | Experimental | Meal description: salt-restricted (1500 mg to 2000 mg daily), > 2100 kilocalorie, high protein (>80 g daily) in addition to receiving standard pamphlet receipt |
|
| Dietary Advice | Active Comparator | Standard of care, advice on salt-restriction using standard pamphlet receipt |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meal delivery | Other | The food will be pre-packaged for storage and patient will prepare these meals at home |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of therapeutic paracenteses | Number of paracenteses | From date of randomization until 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of life | 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. | baseline, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of hospital-bed days in 12 weeks | The number of days the participants were hospitalized after randomization | From date of randomization until 12 weeks |
| Change in diuretic dose | The dose amount changes the participant's medications that are considered diuretics |
Inclusion Criteria:
Adult 18 years or older of age
Clinical diagnosis of cirrhosis with ascites. Diagnosis of cirrhosis will be based upon:
3) At least one of the following: Any cause hospitalization within 90 days OR outpatient therapeutic paracentesis within 30 days
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elliot Tapper | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| D001201 | Ascites |
| D008107 | Liver Diseases |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D004066 | Digestive System Diseases |
| D001928 | Brain Diseases, Metabolic |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Standard pamphlet with Dietary Advice | Other | Explains how to maintain a low-sodium diet |
|
| baseline, week 12 |
| Change in frailty measures | 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. | baseline, week 12 |
| Change in frailty measures | Change in time taken to walk 5 meters (walk speed measured in meters per second) | baseline, week 12 |
| Quality of life | 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 | baseline, week 12 |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |