Feasibility of an App-based Nutrition & Exercise Program in Cirrhosis

Study Overview
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Brief Summary
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The personalized nutrition and exercise app was designed for use by individuals living with chronic conditions. The pilot study examines the acceptance and use of the online, interactive program to support self-management in cirrhosis.

Detailed Description
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Patients living with chronic disease are at-risk for frailty because of their potentially sedentary lifestyle and/or symptoms. Supervised exercise programs are useful for improving or maintaining physical capacity as measured by common physical function measures. However, accessibility is limited due to scheduling, transportation, employment, and residential location. Unsupervised, self-directed home-based programs have had limited success due to absence of peer support and accountability. An alternative is an app-based program that offers interactive engagement with study staff and accountability. Further, follow-along videos and tracking for both nutrition and exercise can be completed at the patient's convenience. A 12-week pilot study with patients living with cirrhosis will assess the acceptability of the programming. The hypothesis is that study participants will find the customization of the app and interaction with the study staff acceptable as measured by completion rates (primary study endpoint). Secondary outcomes include change in measures (0-12 weeks) for the 6-minute walk test (6MWT), thigh muscle thickness, and chair sit-to-stands. At the end of the study, participants will also complete a program satisfaction survey (developed in-house). Interviews with participants, caregivers, and study staff, conducted via videoconference at 4-6 weeks and end of study, will be descriptively analysed to identify feasibility, acceptability, and perceived utility of the program. Analyses will also identify areas for program improvement.

Official Title
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The Acceptability of an App-based, Interactive, Personalized Nutrition and Exercise Program to Support Self-management in Cirrhosis: a Pilot Study

Conditions
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Cirrhosis, Liver, Hepatic Encephalopathy

Intervention / Treatment
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* Behavioral: Nutrition and Exercise app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult (aged 18 years and older) diagnosis of cirrhosis (MELD<25) according to biopsy, imaging, elastography, or other fulfill the guideline-based prophylaxis in place for high risk gastroesophageal varices able to communicate (e.g., speak, read, and write) in English provide informed written consent for self Exclusion Criteria: hepatocellular carcinoma (HCC) outside of the Edmonton liver transplant criteria previous myocardial infarction EF <50% ischemia on stress testing oxygen saturation <95% non-HCC malignancy end-stage renal disease. at the discretion of the healthcare team if a participant can participate in the pilot study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Nutrition and Exercise App<br>The exercise and nutrition app intervention will be provided to study participants. The app offers self-directed and supervised (virtual) programming to support nutrition and exercise self-management. Each participant follows a program that has been tailored to their overall health, physical function, and needs. | Behavioral: Nutrition and Exercise app<br>* Personalized, home-based, interactive therapy app<br>* Other names: Heal-Me;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Retention/Adherence | The number of participants who complete the 12-week nutrition and exercise program and meet 70% of the nutrition and exercise goals. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-MWT | The change in distance walked in 6 minutes. | 12 weeks | 
| Program Satisfaction | Self-reported satisfaction with the nutrition and exercise program. | 12 weeks |