Back to resultsA Digital Solution for Individuals With Non Alcoholic Fatty Liver Disease
Primary Purpose
Non Alcoholic Fatty Liver Disease
Status
Completed
Phase
Not Applicable
Locations
Iceland
Study Type
Interventional
Intervention
A digital care solution for patients with NAFLD
Sponsored by
About this trial
This is an interventional treatment trial for Non Alcoholic Fatty Liver Disease focused on measuring non alcoholic fatty liver disease, digital solution, lifestyle change, remote monitoring, clinical outcome, quality of life, digital intervention, non-alcoholic steatohepatitis
Eligibility Criteria
Inclusion Criteria:
- Adults with a NAFLD diagnosis, defined as:
Confirmed liver steatosis >5%, with a FibroScan CAP cutoff score of > 294 decibel (dB)/m among individuals with one or more of the following: Type 2 diabetes OR BMI>30 OR Metabolic syndrome OR Previous diagnosis of NAFLD within the last 12 months
- for individuals with type 2 diabetes: Stable dose of antidiabetic medication the last 90 days before screening (metformin, glitazones, glucagon like peptide-1 (GLP-1) analogues, sodium-glucose co transporter-2 (SGLT-2) inhibitor, sulfonylurea, insulin)
- Capacity to give informed consent and understands verbal and written Icelandic
- Owns and knows how to operate a smartphone
- Willing and able to comply with the study intervention, all scheduled visits and procedures
Exclusion Criteria:
- Insulin use
- Known or self-reported cirrhosis
- Alcohol consumption over 14 units/week for males, 7 units/week for women
- Self-reported Hepatitis B (HepB), Hepatitis C (HepC), human immunodeficiency virus (HIV), or autoimmune hepatitis
- Vitamin E intake of > 400 IU/day - unless stable for 12 weeks prior to baseline
- Taking medications associated with liver steatosis; steroids, methotrexate, tamoxifen, amiodarone, tetracycline, valproic acid
- Self-reported pregnancy
- Participation in a weight loss program
- History of, or any existing medical condition (e.g., ongoing cancer treatment, severe cardiopulmonary- or musculoskeletal disease, stroke, or myocardial infarction in the last 6 months) that, in the opinion of the investigator, would interfere with evaluation of the study intervention or affect the interpretation of the results of the study
Sites / Locations
- Hjartamiðstöðin
- Hjartavernd
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Digital solution group
Arm Description
Participants will be instructed to download a lifestyle-changing mobile application to which they will have access for 9 months. The program aims to provide remote symptom monitoring by a health coach and by having participants enter data (on diet, exercise, weight, stress and energy levels, etc) and patient reported outcomes (PROs) via the SidekickHealth platform to empower positive lifestyle changes. The intervention consists of a 12-week digital behavioral change program with an additional 6-month maintenance program, during which time the patient still has access to the application but with limited features compared to the first 12 weeks. During the total 9-month study period all participants will also receive standard of care.
Outcomes
Primary Outcome Measures
Acceptability and feasibility of the digital program (SK-241) - retention.
Assess retention by percentage of users that complete the SK-241 program at week 12. 'Complete the program' is defined as finishing 75% of the program.
Acceptability and feasibility of the digital program (SK-241) - engagement.
Assess engagement by percentage of users that are active in the SK-241 program during the 12 weeks. 'Active' is defined as visiting the application at least once per week.
Acceptability and feasibility of the digital program (SK-241) - satisfaction.
Assess satisfaction based on the scores in the 18-item mobile health (mHealth) App Usability Questionnaire at week 12.
Answers are scored on a 7-point Likert scale (ranging from 1 for "strongly disagree"to 7 "strongly agree") and total scores range from 18 to 126. The higher the score, the better the usability.
Secondary Outcome Measures
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on weightloss.
Change in weight, from baseline to week 12 and month 9
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on HbA1c.
Changes, from baseline to week 12 and month 9 in:
Hemoglobin A1c (HbA1c), expressed in millimol per mol (mmol/mol).
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on fasting glucose.
Changes, from baseline to week 12 and month 9 in:
fasting glucose, measured in millimol per liter (mmol/L)
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on fasting insulin.
Changes, from baseline to week 12 and month 9 in:
fasting insulin, measured in picomol per liter (pmol//L)
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on liver function.
Changes, from baseline to week 12 and month 9, in liver enzymes in the serum:
Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Gamma- Glutamyl Transferase (GGT), all measured in international units per liter (IU/L)
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on cholesterol.
Changes, from baseline to week 12 and month 9 in:
Total cholesterol, Low Density Lipoprotein - Cholesterol (LDL-C), High Density Lipoprotein - Cholesterol (HDL-C), and triglycerides. These are all measured in millimol per liter (mmol/L)
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on hs-CRP.
Changes, from baseline to week 12 and month 9, in:
high-sensitivity C-reactive protein (hs-CRP), measured in milligram per liter (mg/L)
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on the cardiovascular risk factor blood pressure
Changes, from baseline to week 12 and month 9, in:
Blood pressure in millimeters of mercury (mmHg)
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on the cardiovascular risk factor waist circumference.
Changes, from baseline to week 12 and month 9, in:
Waist circumference in centimeters (cm)
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on the cardiovascular risk factor activity level.
Changes, from baseline to week 12 and month 9, in:
Activity level, as assessed with an in-app step counter, and measured in number of steps
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on body composition.
Changes in body composition (fat mass and lean mass), measured by dual-energy X-ray absorptiometry (DXA) at baseline, week 12 and 9 months.
Fat mass and lean mass are both expressed as percentage (%).
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on liver fat content.
Changes in liver fat fraction (%) assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at baseline, week 12 and 9 months.
The feasibility of adding a digital program (SK-241) to standard of care, by assessing health related quality of life (HRQoL)
Changes in self-reported scores on the EuroQuol Five Dimension - Five Level (EQ-5D-5L) health questionnaire from baseline to week 12 and month 9.
EQ-E5-5L scores range from -0.530 to 1, with higher scores indicating a better health status. A score of 1 indicates full health.
The feasibility of adding a digital program (SK-241) to standard of care, by assessing mental health.
Changes in self-reported scores of the Depression, Anxiety and Stress Scale - 21 Items (DASS-21) questionnaire from baseline to week 12 and month 9.
Each question has a Likert scale of 4 options where 0 represents "did not apply to me" to 3 "applied to me very much". The scores on the subscales range from 0 to 42, and low scores indicate a better mental health status.
The feasibility of adding a digital program (SK-241) to standard of care, by assessing medication adherence.
Changes in self-reported scores on the Morisky Medication adherence Scale (MMAS-8) questionnaire from baseline to week 12 and month 9. The MMAS-8 is an 8-item structured, self-reported medication adherenece measure.
Scores on the MMAS-8 range from 0-8, with 0 reflecting high adherence, 1-2 medium adherence and 3-8 low adherence.
Full Information
NCT ID
NCT05426382
First Posted
June 10, 2022
Last Updated
April 24, 2023
Sponsor
Sidekick Health
Collaborators
Hjartamiðstöðin, Iceland, Hjartavernd, Iceland
1. Study Identification
Unique Protocol Identification Number
NCT05426382
Brief Title
A Digital Solution for Individuals With Non Alcoholic Fatty Liver Disease
Official Title
Sidekick Health Digital Solution (SK-241) for Individuals With Non Alcoholic Fatty Liver Disease (NAFLD): A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
April 24, 2023 (Actual)
Study Completion Date
April 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidekick Health
Collaborators
Hjartamiðstöðin, Iceland, Hjartavernd, Iceland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Sidekick Health has developed a digital behavioral change program (SK-241) specifically designed for people with metabolic derangements and non-alcoholic fatty liver disease (NAFLD). The SK-241 is delivered through a mobile application and aims at improving lifestyle and health outcomes by focusing on improving diet, increasing activity levels and reducing stress. In this study, the feasibility of the newly developed digital behavioral change program (SK-241) will be evaluated in a minimum of 30 individuals with a NAFLD diagnosis. The primary aim is to explore the acceptability of the SK-241 program by its users, in addition to exploring changes in clinical outcomes and medication adherence after a 12-week intervention with 6 months follow up.
Detailed Description
Non-alcoholic fatty liver disease (NAFLD) is an umbrella term used to describe a spectrum of liver pathology, characterized by >5% fat accumulation in the liver (steatosis), among people who drink little or no alcohol. Both genetic and lifestyle-related factors contribute to the pathogenesis of NAFLD. It is strongly associated with metabolic derangements, obesity, insulin resistance and type 2 diabetes mellitus. NAFLD is considered the liver manifestation of metabolic syndrome.
NAFLD can progress from a simple steatosis to a more severe and progressive condition, referred to as non-alcoholic steatohepatitis (NASH), which is characterized by additional liver inflammation and hepatocyte injury with or without fibrosis. In general, 20% of NAFLD patients are believed to progress to NASH.
Finding convenient and effective ways to incorporate lifestyle changes into daily lives of people with NAFLD and NASH is important. Sidekick Health has developed a digital behavioral change program (SK-241) for NAFLD and NASH patients consisting of an interactive mobile application.
The aim of this study is primarily to assess the acceptability and feasibility of adding a digital lifestyle intervention (SK-241) to the standard of care (SoC) for NAFLD patients, by assessing participants engagement, retention and satisfaction with the SK-241 program in a minimum of 30 individuals with a NAFLD diagnosis. In addition, the clinical effectiveness of the program will be explored. A minimum of 30 individuals with a NAFLD diagnosis will be included for a 12-week intervention with 6 months follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Alcoholic Fatty Liver Disease
Keywords
non alcoholic fatty liver disease, digital solution, lifestyle change, remote monitoring, clinical outcome, quality of life, digital intervention, non-alcoholic steatohepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multi-center single-arm open label intervention study
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Digital solution group
Arm Type
Experimental
Arm Description
Participants will be instructed to download a lifestyle-changing mobile application to which they will have access for 9 months. The program aims to provide remote symptom monitoring by a health coach and by having participants enter data (on diet, exercise, weight, stress and energy levels, etc) and patient reported outcomes (PROs) via the SidekickHealth platform to empower positive lifestyle changes.
The intervention consists of a 12-week digital behavioral change program with an additional 6-month maintenance program, during which time the patient still has access to the application but with limited features compared to the first 12 weeks. During the total 9-month study period all participants will also receive standard of care.
Intervention Type
Device
Intervention Name(s)
A digital care solution for patients with NAFLD
Other Intervention Name(s)
SK-241
Intervention Description
A digital solution that provides remote symptom monitoring and support of healthy lifestyle choices through tasks that are made more attractive with gamification and rewards.
Primary Outcome Measure Information:
Title
Acceptability and feasibility of the digital program (SK-241) - retention.
Description
Assess retention by percentage of users that complete the SK-241 program at week 12. 'Complete the program' is defined as finishing 75% of the program.
Time Frame
12 weeks
Title
Acceptability and feasibility of the digital program (SK-241) - engagement.
Description
Assess engagement by percentage of users that are active in the SK-241 program during the 12 weeks. 'Active' is defined as visiting the application at least once per week.
Time Frame
12 weeks
Title
Acceptability and feasibility of the digital program (SK-241) - satisfaction.
Description
Assess satisfaction based on the scores in the 18-item mobile health (mHealth) App Usability Questionnaire at week 12.
Answers are scored on a 7-point Likert scale (ranging from 1 for "strongly disagree"to 7 "strongly agree") and total scores range from 18 to 126. The higher the score, the better the usability.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on weightloss.
Description
Change in weight, from baseline to week 12 and month 9
Time Frame
9 months
Title
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on HbA1c.
Description
Changes, from baseline to week 12 and month 9 in:
Hemoglobin A1c (HbA1c), expressed in millimol per mol (mmol/mol).
Time Frame
9 months
Title
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on fasting glucose.
Description
Changes, from baseline to week 12 and month 9 in:
fasting glucose, measured in millimol per liter (mmol/L)
Time Frame
9 months
Title
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on fasting insulin.
Description
Changes, from baseline to week 12 and month 9 in:
fasting insulin, measured in picomol per liter (pmol//L)
Time Frame
9 months
Title
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on liver function.
Description
Changes, from baseline to week 12 and month 9, in liver enzymes in the serum:
Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Gamma- Glutamyl Transferase (GGT), all measured in international units per liter (IU/L)
Time Frame
9 months
Title
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on cholesterol.
Description
Changes, from baseline to week 12 and month 9 in:
Total cholesterol, Low Density Lipoprotein - Cholesterol (LDL-C), High Density Lipoprotein - Cholesterol (HDL-C), and triglycerides. These are all measured in millimol per liter (mmol/L)
Time Frame
9 months
Title
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on hs-CRP.
Description
Changes, from baseline to week 12 and month 9, in:
high-sensitivity C-reactive protein (hs-CRP), measured in milligram per liter (mg/L)
Time Frame
9 months
Title
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on the cardiovascular risk factor blood pressure
Description
Changes, from baseline to week 12 and month 9, in:
Blood pressure in millimeters of mercury (mmHg)
Time Frame
9 months
Title
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on the cardiovascular risk factor waist circumference.
Description
Changes, from baseline to week 12 and month 9, in:
Waist circumference in centimeters (cm)
Time Frame
9 months
Title
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on the cardiovascular risk factor activity level.
Description
Changes, from baseline to week 12 and month 9, in:
Activity level, as assessed with an in-app step counter, and measured in number of steps
Time Frame
9 months
Title
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on body composition.
Description
Changes in body composition (fat mass and lean mass), measured by dual-energy X-ray absorptiometry (DXA) at baseline, week 12 and 9 months.
Fat mass and lean mass are both expressed as percentage (%).
Time Frame
9 months
Title
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on liver fat content.
Description
Changes in liver fat fraction (%) assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at baseline, week 12 and 9 months.
Time Frame
9 months
Title
The feasibility of adding a digital program (SK-241) to standard of care, by assessing health related quality of life (HRQoL)
Description
Changes in self-reported scores on the EuroQuol Five Dimension - Five Level (EQ-5D-5L) health questionnaire from baseline to week 12 and month 9.
EQ-E5-5L scores range from -0.530 to 1, with higher scores indicating a better health status. A score of 1 indicates full health.
Time Frame
9 months
Title
The feasibility of adding a digital program (SK-241) to standard of care, by assessing mental health.
Description
Changes in self-reported scores of the Depression, Anxiety and Stress Scale - 21 Items (DASS-21) questionnaire from baseline to week 12 and month 9.
Each question has a Likert scale of 4 options where 0 represents "did not apply to me" to 3 "applied to me very much". The scores on the subscales range from 0 to 42, and low scores indicate a better mental health status.
Time Frame
9 months
Title
The feasibility of adding a digital program (SK-241) to standard of care, by assessing medication adherence.
Description
Changes in self-reported scores on the Morisky Medication adherence Scale (MMAS-8) questionnaire from baseline to week 12 and month 9. The MMAS-8 is an 8-item structured, self-reported medication adherenece measure.
Scores on the MMAS-8 range from 0-8, with 0 reflecting high adherence, 1-2 medium adherence and 3-8 low adherence.
Time Frame
9 months
Other Pre-specified Outcome Measures:
Title
Exploratory objective: liver steatosis
Description
Changes in Controlled Attenuation Parameter (CAP) Fibroscan score. CAP Fibroscan score is measured in decibels per meter (dB/m) and assessed at baseline, week 12 and 9 months.
CAP Fibroscan scores range from from 100 to 400 dB/m, with a lower score indicating a better outcome as it indicates less liver steatosis.
Time Frame
9 months
Title
Exploratory objective: liver fibrosis
Description
Changes in Liver Stiffness Measurement (LSM) Fibroscan score.The LSM Fibroscan scores are measured in kilopascal (kPa) and assessed at baseline, week 12 and 9 months.
LSM FibroScan scores range from 2.5 kPa to 75 kPa. A lower scores indicates a better outcome.
Time Frame
9 months
Title
Safety objective: Monitor the safety and any potential adverse effects of the digital solution on patients and outcomes.
Description
Incidence of adverse events (AE) and serious adverse events (SAE) reportings at week 12 and 9 months.
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults with a NAFLD diagnosis, defined as:
Confirmed liver steatosis >5%, with a FibroScan CAP cutoff score of > 294 decibel (dB)/m among individuals with one or more of the following: Type 2 diabetes OR BMI>30 OR Metabolic syndrome OR Previous diagnosis of NAFLD within the last 12 months
for individuals with type 2 diabetes: Stable dose of antidiabetic medication the last 90 days before screening (metformin, glitazones, glucagon like peptide-1 (GLP-1) analogues, sodium-glucose co transporter-2 (SGLT-2) inhibitor, sulfonylurea, insulin)
Capacity to give informed consent and understands verbal and written Icelandic
Owns and knows how to operate a smartphone
Willing and able to comply with the study intervention, all scheduled visits and procedures
Exclusion Criteria:
Insulin use
Known or self-reported cirrhosis
Alcohol consumption over 14 units/week for males, 7 units/week for women
Self-reported Hepatitis B (HepB), Hepatitis C (HepC), human immunodeficiency virus (HIV), or autoimmune hepatitis
Vitamin E intake of > 400 IU/day - unless stable for 12 weeks prior to baseline
Taking medications associated with liver steatosis; steroids, methotrexate, tamoxifen, amiodarone, tetracycline, valproic acid
Self-reported pregnancy
Participation in a weight loss program
History of, or any existing medical condition (e.g., ongoing cancer treatment, severe cardiopulmonary- or musculoskeletal disease, stroke, or myocardial infarction in the last 6 months) that, in the opinion of the investigator, would interfere with evaluation of the study intervention or affect the interpretation of the results of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigríður Björnsdóttir, MD PhD
Organizational Affiliation
Hjartamiðstöðin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hjartamiðstöðin
City
Kopavogur
ZIP/Postal Code
203
Country
Iceland
Facility Name
Hjartavernd
City
Kópavogur
ZIP/Postal Code
203
Country
Iceland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Anonymized Individual Participant Data (IPD) may be shared with other researchers for relevant research purposes following complementary ethical review and approval from the Ethical Review Board.
Learn more about this trial
A Digital Solution for Individuals With Non Alcoholic Fatty Liver Disease
We'll reach out to this number within 24 hrs