NCT06209216

Twenty-Four Seven Functional Status in Total Hip Replacement

An Observational Study to Explore Twenty-Four Seven Functional Status Measures in Total Hip Replacement (LEARNT)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Koneksa Health · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to define digital remote monitoring measures for functional status (activities of daily living) in patients receiving total hip replacement. Functional status will be collected using a study iPhone and two wearable wrist monitors.

Detailed description

Approximately 25 participants will be enrolled in this study. The study consists of a 1-week Screening period, a 1-week Baseline period, up to 6-week assessment period (post-surgery), and an end of participation (EOP) visit. With the exception of in clinic visits at the beginning and end of study, this observational study will leverage fully remote data capture. The categories of functional status and corresponding measures captured in this study include: 1. Physical activity and mobility, with outcome measures including hourly and daily step count, gait speed, and metabolic equivalent of task. 2. Vital signs, with outcome measures including heart rate, heart rate variability and blood pressure. 3. Sleep concept, with outcome measures including sleep duration, sleep quality, sleepiness and sleep timing. 4. HRQoL captured using validated instruments and diaries via electronic patient reported outcomes (ePRO) platforms, assessing aspects of health that are meaningful to individual's hip replacement such as disease- and treatment-related symptoms and the impact their physical health may have on activities of daily living, their work life, and socializing.

Conditions

• Total Hip Replacement

Timeline

• Start date: 2023-12-13
• Primary completion: 2024-10-07
• Completion: 2024-10-07
• First posted: 2024-01-17
• Last updated: 2024-11-12

Locations

1 site across 1 country: United States