Twenty-Four Seven Functional Status in Total Hip Replacement

NCT06209216 | Completed

• 1 other identifier: KH009
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Replacement

Keywords

Functional Status

Outcome Measures

Primary Outcomes (10)

• 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

• 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

Study Arms (1)

Total Hip Replacement

No intervention

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants requiring total hip replacement surgery will participate in this study for \~6 weeks.

You may qualify if:

• Participants diagnosed with osteoarthritis of the hip or degenerative joint disease and have decided to undergo total hip arthroplasty
• Patients willing to sign the informed consent form
• Age 30 and older
• 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

You may not qualify if:

• 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
• Secondary total hip replacement on the same side
• Hip replacement for neoplasm, proximal femoral fracture, or other causes than osteoarthritis
• Contemporary bilateral replacement
• History of substance abuse in the last 6 months, excluding medical or recreational non-inhaled marijuana
• Current cancer
• Presence of neurological diseases previous to and/or following surgery (peripheral neuropathy is generally acceptable)
• Congenital abnormalities
• Patients with active infection within last 30 days
• Psychotropic drugs except for pain management and antidepressants

Sponsors & Collaborators

• Koneksa Health: lead

Study Sites (1)

Premier Medical Associates

The Villages, Florida, 32159, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 17, 2024
• Study Start: December 13, 2023
• Primary Completion: October 7, 2024
• Study Completion: October 7, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

US (1)