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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Hip Replacement | No intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Hip Assessment - In Clinic | Harris Hip Score | Baseline Day 1 through Day 42 End of Participation |
| Mobile Vital Signs via Mobile Blood Pressure Cuff | Orthostatic blood pressure | Baseline Day 1 through Day 42 End of Participation |
| Daily Measurements via Wrist-worn Device | Heart rate variability, body temperature, step count, blood oxygen saturation | Baseline Day 1 through Day 42 End of Participation |
| Objective Measures of Sleep via Wrist-worn Device | Sleep staging measured by a combination of heart rate variability + actigraphy + blood oxygen saturation and vital signs during sleep | Baseline Day 1 through Day 42 End of Participation |
| Motor Function Assessments via Koneksa Application | Gait (20 second walk test) | Baseline Day 1 through Day 42 End of Participation |
| Participant Diary via Koneksa Application | Pain level likert scale, pain medication use, walking aid use | Baseline Day 1 through Day 42 End of Participation |
| Sleep Electronic Patient Reported Outcomes | Sleep Diary and Stanford Sleepiness Scale | Baseline Day 1 through Day 42 End of Participation |
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Inclusion Criteria:
Exclusion Criteria:
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Participants requiring total hip replacement surgery will participate in this study for ~6 weeks.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premier Medical Associates | The Villages | Florida | 32159 | United States |
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| Quality of Life Patient Reported Questionnaire Scores |
Instrumental Activities of Daily Living Scale, PHQ-9 for Depression Score, Functional Assessment of Chronic Illness Therapy - Fatigue (PROMIS SF v1.0 Fatigue 13a) Score, Brief Pain Inventory Short Form for Pain Score |
| Baseline Day 1 through Day 42 End of Participation |
| Additional Questionnaire via Koneksa Platform | Usability for devices and app-based study-specific assessments questionnaire, questionnaires for site clinical care team likelihood to recommend all devices used, and app-based assessments, questionnaires for understanding of tasks and assessment of meaningfulness, participant and/or caregiver likelihood to recommend, ease of use and satisfaction | Baseline Day 1 through Day 365 End of Participation |
| Clinician Reported Adverse Events | Clinical event defined as event requiring medical intervention from call to doctor or emergency room services (such as fall) | Baseline Day 1 through Day 365 End of Participation |