Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07401550
Brief Summary:
This prospective, observational cohort study will evaluate the associations between wearable-derived biometrics and cardiovascular health, quantified by the American Heart Association's Life's Essential 8 framework, as well as related cardiovascular risk factors. The study aims to determine whether wearable biometrics can support the assessment of cardiovascular health and cardiovascular disease risk, both when used in isolation and in combination with point-of-care assessments.
Detailed Description:
Participants will be provided with a Fitbit Charge 6 to wear continuously for six-months. These wearable data will be collected via Fitabase (Small Steps Labs LLC) for the duration of the study.
At baseline, mid-point (three months), and end-point (six months), participants will undergo a clinical cardiovascular health assessment and Life's Essential 8 score will be calculated. Life's Essential 8, established by the American Heart Association, is a composite metric comprising four Health Behaviours and four Health Factors, and provides individuals with a score ranging from 0 (poor health) to 100 (optimal health). Life's Essential 8 health tiers are defined as 'Low' (\<50), 'Moderate' (50-79), and 'High' (80-100). Alongside Life's Essential 8, during each clinical assessment, four patient-reported outcome measures will be collected: EQ-5D-5L, International Physical Activity Questionnaire, Patient Health Questionnaire 9, and Generalized Anxiety Disorder 7.
Participants will also complete patient-reported outcome measures online once per week for the duration of the study. These include the Modified Wisconsin Upper Respiratory Symptom Scale (WURSS), Alcohol Intake Questionnaire, Single-Item Sleep Quality Scale (SQS), Patient Health Questionnaire 4 (PHQ-4), and the two-item Modified Hooper Questionnaire for stress and fatigue. Once per month they will complete the Pittsburgh Sleep Quality Index (PSQI).
Study:
NCT07401550
Study Brief:
Protocol Section:
NCT07401550