Health Condition 1: K769- Liver disease, unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
Abbott Healthcare Products B.V.
Eligibility
Inclusion criteria
Inclusion criteria: For Cohort A and Cohort B 1. Adult participants aged 18 to 65 years (both inclusive) who are willing to provide written informed consent, including consent for AV recording via a mobile application, and who agree to adhere to all study procedures. Only For Cohort A 2. Adult subjects who do not have CLD, as confirmed by a clinician, and who report no fatigue, as assessed by the Patient Global Impression of Severity (PGI-S) with a response of “none. ?. Only for Cohort B: 3. Participants diagnosed with CLD who are receiving standard care for CLD and self-reported moderate to severe fatigue, as assessed by the Patient Global Impression of Severity (PGI-S) with responses of “moderate, ? “severe, ? or “very severe ?.
Exclusion criteria
Exclusion criteria: 1. Participants will be excluded if they do not have access to a mobile device or if their mobile device does not meet the specifications required to use the Blueskeye AI application, as outlined in the user manual. This will be verified by trained site staff. 2. Participants receiving treatment for fatigue from the last 3 weeks prior to screening. 3. Participants with a known history of Parkinson’s disease. 4. Participants with a history of alcohol or drug abuse within the last three months prior to screening or those currently abusing alcohol (greaterthan 7 drinks per week for females and graterthan 14 drinks per week for males) or drugs, as determined by self-report or medical records. 5. Women of childbearing potential will be excluded if they are currently pregnant, planning to become pregnant during the study, or breastfeeding. Participants must agree to use effective contraception methods during the study. At screening, urine pregnancy tests will be conducted for Women of childbearing potential to confirm the eligibility. 6. Participants who are unable to speak or read English. 7. Participants who have undergone surgery within the past three months or have planned surgery within the next month from the screening date. 8. Participants with any comorbidity or concurrent medical condition (other than CLD or its related comorbidities), including but not limited to depression, that, at the discretion of the Investigator, might prevent adherence to the trial procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary analysis will be the evaluation of the correlation between each of the parameters assessed for fatigue score by the AI interactive tool and each PRO tool, the overall study visits in which both PROs and AI tool were assessed. The correlation will be calculated for all these visits combined as well as over both groups. In addition, both groups will be analyzed separately. The Pearson correlation coefficient will be used to assess correlation. Further details will be defined in the Statistical Analysis Plan (SAP). Primary endpoint outcomes will be assessed based on the PPS population. As a pre-processing step, we will normalize the raw fatigue scores from PROs to the scale 0-1 using the min-max normalization technique. The maximum value of each PRO is the highest value that can be scored (1), and the minimum value of each PRO is the lowest value that can be scored (0). Timepoint: Visit 1(day -2 to day 1) to Visit 10 (Day 22) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint outcomes will be evaluated based on the FAS population. Out of N equal to metrics, those that will have the highest correlation with PRO fatigue scores, the RMSE ranges will be estimated from the linear correlation analysis of combined cohorts from the Primary Efficacy outcomes. Depending on the Primary Efficacy outcome, a numerical scale will be generated to provide value for the next phase of the study related to fatigue scoring models. Supporting information aims to be collected from the combined cohort correlation analysis to formulate a linear model for mapping a subset of relevant metrics identified in the Primary Efficacy to a normalized fatigue score. AV recordings collected without PROs will be used for temporal analysis of the changes in metrics over time. This analysis intends to understand the differences in temporal trends in the collected metrics between Cohort A and Cohort B. Timepoint: Visit 1(day -2 to day 1) to Visit 10 (Day 22) | — |
Countries
India
Contacts
Public ContactGamar Akhundova Unadkat
Abbott EPD - Development SMM
Outcome results
None listed