Total Hip Replacement
Conditions
Keywords
Functional Status
Brief 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.
Interventions
None listed
Sponsors
Koneksa Health
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants diagnosed with osteoarthritis of the hip or degenerative joint disease and have decided to undergo total hip arthroplasty 2. Patients willing to sign the informed consent form 3. Age 30 and older 4. Demonstrated ability to perform satisfactory at-home assessments as well as the mobile application to synchronize data collection and respond to questionnaires during the screening period
Exclusion criteria
1. Participants with clinically unstable serious diseases (e.g., heart or lung disease) that would deem them unfit for the study in the Investigator's opinion 2. Secondary total hip replacement on the same side 3. Hip replacement for neoplasm, proximal femoral fracture, or other causes than osteoarthritis 4. Contemporary bilateral replacement 5. History of substance abuse in the last 6 months, excluding medical or recreational non-inhaled marijuana 6. Current cancer 7. Presence of neurological diseases previous to and/or following surgery (peripheral neuropathy is generally acceptable) 8. Congenital abnormalities 9. Patients with active infection within last 30 days 10. Psychotropic drugs except for pain management and antidepressants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Hip Assessment - In Clinic | Baseline Day 1 through Day 42 End of Participation | Harris Hip Score |
| Mobile Vital Signs via Mobile Blood Pressure Cuff | Baseline Day 1 through Day 42 End of Participation | Orthostatic blood pressure |
| Daily Measurements via Wrist-worn Device | Baseline Day 1 through Day 42 End of Participation | Heart rate variability, body temperature, step count, blood oxygen saturation |
| Objective Measures of Sleep via Wrist-worn Device | Baseline Day 1 through Day 42 End of Participation | Sleep staging measured by a combination of heart rate variability + actigraphy + blood oxygen saturation and vital signs during sleep |
| Motor Function Assessments via Koneksa Application | Baseline Day 1 through Day 42 End of Participation | Gait (20 second walk test) |
| Participant Diary via Koneksa Application | Baseline Day 1 through Day 42 End of Participation | Pain level likert scale, pain medication use, walking aid use |
| Sleep Electronic Patient Reported Outcomes | Baseline Day 1 through Day 42 End of Participation | Sleep Diary and Stanford Sleepiness Scale |
| Quality of Life Patient Reported Questionnaire Scores | Baseline Day 1 through Day 42 End of Participation | 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 |
| Additional Questionnaire via Koneksa Platform | Baseline Day 1 through Day 365 End of Participation | 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 |
| Clinician Reported Adverse Events | Baseline Day 1 through Day 365 End of Participation | Clinical event defined as event requiring medical intervention from call to doctor or emergency room services (such as fall) |
Countries
United States
Outcome results
None listed