Trial · NCT07912671
Registered outcomes62
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
41 to 60 of 62
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Change in Peripheral Oxygen Saturation (SpO₂) | Baseline and 12 months | Change in peripheral oxygen saturation (percentage points) from baseline to 12 months. |
| Other | Difference in Estimated Life Expectancy | 12 months | Difference in estimated life expectancy (years) between the two groups, derived from the observed difference in Life's Essential 8 (LE8) scores at 12 months using a prespecified life-expectancy estimation model. |
| Other | Heart Rate Variability (HRV) Parameters | Baseline and 12 months | Exploratory changes from baseline to 12 months in time-domain heart rate variability parameters, including SDNN, SDANN, RMSSD, and pNN50, derived from 24-hour Holter recordings. Changes will be compared between the two study groups. Continuous smartwatch-derived heart rate data will be used as supplementary information. |
| Other | Proportion of Participants With Clinically Significant Depressive Symptoms (PHQ-9 Score ≥10) | 12 months | Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report questionnaire with a total score ranging from 0 to 27. Higher scores indicate more severe depressive symptoms. A total score of 10 or higher will be used to identify participants with clinically significant depressive symptoms. The proportion of participants with a PHQ-9 total score of 10 or higher at 12 months will be compared between the intervention and control groups. A positive screening result does not establish a clinical diagnosis of major depressive disorder. |
| Other | Average Daily Steps | From baseline through 12 months | Pre-specified exploratory outcome. The average number of steps taken per day, continuously recorded by smartwatches throughout the study period. |
| Other | Daily Sedentary Time | From baseline through 12 months | Pre-specified exploratory outcome. The average duration of sedentary behavior per day, continuously recorded by smartwatches throughout the study period. |
| Other | Weekly Aerobic Exercise Time | From baseline through 12 months | Pre-specified exploratory outcome. The total duration of aerobic exercise accumulated per week, continuously recorded by smartwatches throughout the study period |
| Other | Average Daily Caloric Expenditure | From baseline through 12 months | Pre-specified exploratory outcome. The average energy expenditure (calories) per day, continuously recorded by smartwatches throughout the study period. |
| Other | Average Daily Wear Time | From baseline through 12 months | Pre-specified exploratory outcome. The average duration of smartwatch wear time per day, used to assess participant adherence to the device protocol. |
| Other | Data Availability (Successful Acquisition Rate) | From baseline through 12 months | Pre-specified exploratory outcome. The proportion of the study period with data successfully collected by the smartwatch, used to assess data availability. |
| Other | Magnitude of Heart Rate Reduction | From baseline through 12 months | Pre-specified exploratory outcome. The extent of reduction in heart rate from baseline levels, derived from continuous smartwatch monitoring. |
| Other | Heart Rate Variability/Fluctuation | From baseline through 12 months | Pre-specified exploratory outcome. The variability or fluctuation of heart rate over time, continuously recorded by smartwatches throughout the study period. |
| Other | Time to First Heart Rate Target Achievement | From baseline through 12 months | Pre-specified exploratory secondary outcome. The time elapsed from the start of the study to the first instance of achieving the predefined heart rate target. |
| Other | System Usability Scale (SUS) Score | 12 months | Usability of the wearable device and accompanying digital health management system will be assessed in the experimental group using the System Usability Scale (SUS) at 12 months. The SUS score ranges from 0 to 100, with higher scores indicating better perceived usability. Results will be summarized descriptively without between-group comparison. |
| Other | Number of Outpatient Visits | From baseline through 12 months | The total number of outpatient visits per participant from baseline through 12 months will be assessed using medical records and structured follow-up records. The outcome will be reported as the number of outpatient visits per participant and compared between the two study groups. |
| Other | Direct Medical Costs | From baseline through 12 months | Exploratory assessment of direct medical costs in both study groups, collected from baseline through 12 months in relation to healthcare resource utilization. |
| Other | Number of Emergency Department Visits | From baseline through 12 months | The total number of emergency department visits per participant from baseline through 12 months will be assessed using medical records and structured follow-up records. The outcome will be reported as the number of emergency department visits per participant and compared between the two study groups. |
| Other | Number of All-Cause Hospitalizations | From baseline through 12 months | The total number of all-cause hospital admissions per participant from baseline through 12 months will be assessed using hospitalization records and structured follow-up records. The outcome will be reported as the number of hospitalizations per participant and compared between the two study groups. |
| Other | Total Length of Hospital Stay | From baseline through 12 months | The cumulative length of hospital stay per participant from baseline through 12 months will be calculated by summing the duration of all hospitalizations, based on hospital admission and discharge records. The outcome will be reported in days per participant and compared between the two study groups. |
| Other | Number of Cardiovascular-Related Diagnostic Examinations | From baseline through 12 months | The total number of cardiovascular-related diagnostic examinations per participant from baseline through 12 months will be assessed using medical records and structured follow-up records. The outcome will be reported as the number of examinations per participant and compared between the two study groups. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07912671/registered?page=3