Twenty-Four Seven Functional Status in Total Hip Replacement

Completed

• Conditions: Total Hip Replacement

• Registration Number: NCT06209216
• Lead Sponsor: Koneksa Health

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.

Study Timeline

• Study Start: 2023-12-13
• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2024-01-07
• Study First Posted: 2024-01-17
• Primary Completion: 2024-10-07
• Study Completion: 2024-10-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Motor Function Assessments via Koneksa Application	Baseline Day 1 through Day 42 End of Participation	Gait (20 second walk test)
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
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
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
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
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)
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

Trial Locations

Locations (1)

Premier Medical Associates; 🇺🇸 The Villages, Florida, United States