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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06209216
Other study ID # KH009
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 13, 2023
Est. completion date May 31, 2024

Study information

Verified date January 2024
Source Koneksa Health
Contact Koneksa Health
Phone 551-866-0025
Email KH009@koneksahealth.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 30 Years and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
United States Premier Medical Associates The Villages Florida

Sponsors (1)

Lead Sponsor Collaborator
Koneksa Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Hip Assessment - In Clinic Harris Hip Score Baseline Day 1 through Day 42 End of Participation
Primary Mobile Vital Signs via Mobile Blood Pressure Cuff Orthostatic blood pressure Baseline Day 1 through Day 42 End of Participation
Primary 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
Primary 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
Primary Motor Function Assessments via Koneksa Application Gait (20 second walk test) Baseline Day 1 through Day 42 End of Participation
Primary Participant Diary via Koneksa Application Pain level likert scale, pain medication use, walking aid use Baseline Day 1 through Day 42 End of Participation
Primary Sleep Electronic Patient Reported Outcomes Sleep Diary and Stanford Sleepiness Scale Baseline Day 1 through Day 42 End of Participation
Primary 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
Primary 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
Primary 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
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