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NCT Number: NCT06209216

Twenty-Four Seven Functional Status in Total Hip Replacement

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.

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Key information

Conditions

Total Hip Replacement

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Premier Medical Associates

The Villages, Florida, 32159, United States

About this study

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:

  • Physical activity and mobility, with outcome measures including hourly and daily step count, gait speed, and metabolic equivalent of task.
  • Vital signs, with outcome measures including heart rate, heart rate variability and blood pressure.
  • Sleep concept, with outcome measures including sleep duration, sleep quality, sleepiness and sleep timing.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Overall Hip Assessment - In Clinic

    Time frame: Baseline Day 1 through Day 42 End of Participation

    Harris Hip Score

  2. Mobile Vital Signs via Mobile Blood Pressure Cuff

    Time frame: Baseline Day 1 through Day 42 End of Participation

    Orthostatic blood pressure

  3. Daily Measurements via Wrist-worn Device

    Time frame: Baseline Day 1 through Day 42 End of Participation

    Heart rate variability, body temperature, step count, blood oxygen saturation

  4. Objective Measures of Sleep via Wrist-worn Device

    Time frame: 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

  5. Motor Function Assessments via Koneksa Application

    Time frame: Baseline Day 1 through Day 42 End of Participation

    Gait (20 second walk test)

  6. Participant Diary via Koneksa Application

    Time frame: Baseline Day 1 through Day 42 End of Participation

    Pain level likert scale, pain medication use, walking aid use

  7. Sleep Electronic Patient Reported Outcomes

    Time frame: Baseline Day 1 through Day 42 End of Participation

    Sleep Diary and Stanford Sleepiness Scale

  8. Quality of Life Patient Reported Questionnaire Scores

    Time frame: 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

  9. Additional Questionnaire via Koneksa Platform

    Time frame: 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

  10. Clinician Reported Adverse Events

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Koneksa Health

Industry

Registry information

Official study title

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

Acronym: LEARNT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 17, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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