Twenty-Four Seven Functional Status in Total Hip Replacement (LEARNT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Total Hip Replacement

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 Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Koneksa Health; Phone Number: 551-866-0025; Email: KH009@koneksahealth.com

Study Locations

• United States
  • Florida
    • The Villages, Florida, United States, 32159
      • Recruiting
      • Premier Medical Associates
      • Contact: Lori Dameron; Phone Number: 407-701-0332; Email: ldameron@vantagetrials.com
      • Contact: Paige A Deckard, LPN; Phone Number: 407-701-0332; Email: pdeckard@vantagetrials.com
      • Principal Investigator: Sanjay B Shah, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Total Hip Replacement; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Koneksa Health

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: January 7, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 7, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Functional Status
• Other Study ID Numbers: KH009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No