Total Hip ReplacementLEARNTNCT06209216
Twenty-Four Seven Functional Status in Total Hip Replacement
An observational study of Total Hip Replacement, run by Koneksa Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Total Hip Replacement
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2023to 7 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants requiring total hip replacement surgery will participate in this study for ~6 weeks.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Premier Medical Associates
The Villages, Florida, 32159
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Total Hip Replacement
- Keywords
- Functional Status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Total Hip Replacement | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Hip Assessment - In Clinic
Harris Hip Score
Measured: Baseline Day 1 through Day 42 End of Participation
Mobile Vital Signs via Mobile Blood Pressure Cuff
Orthostatic blood pressure
Measured: 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
Measured: 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
Measured: Baseline Day 1 through Day 42 End of Participation
Motor Function Assessments via Koneksa Application
Gait (20 second walk test)
Measured: Baseline Day 1 through Day 42 End of Participation
Participant Diary via Koneksa Application
Pain level likert scale, pain medication use, walking aid use
Measured: Baseline Day 1 through Day 42 End of Participation
Sleep Electronic Patient Reported Outcomes
Sleep Diary and Stanford Sleepiness Scale
Measured: 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
Measured: 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
Measured: 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)
Measured: Baseline Day 1 through Day 365 End of Participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start13 Dec 2023
- Primary completion7 Oct 2024
- Study completion7 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koneksa Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209216
- Sponsor's protocol ID
- KH009
- Acronym
- LEARNT
- Status last verified
- Nov 2024
- First submitted
- 21 Dec 2023
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Explore Twenty-Four Seven Functional Status Measures in Total Hip Replacement (LEARNT)
- ClinicalTrials.gov ID
- NCT06209216
- Acronym / sponsor ID
- LEARNT / KH009
- Conditions
- Total Hip Replacement
- Keywords
- Functional Status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Koneksa HealthIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 7 Oct 2024 (actual)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Hip Replacement | – | –No intervention |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants requiring total hip replacement surgery will participate in this study for ~6 weeks.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Hip Assessment - In Clinic
Time frame: Baseline Day 1 through Day 42 End of Participation
Harris Hip Score
Mobile Vital Signs via Mobile Blood Pressure Cuff
Time frame: Baseline Day 1 through Day 42 End of Participation
Orthostatic blood pressure
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
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
Motor Function Assessments via Koneksa Application
Time frame: Baseline Day 1 through Day 42 End of Participation
Gait (20 second walk test)
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
Sleep Electronic Patient Reported Outcomes
Time frame: Baseline Day 1 through Day 42 End of Participation
Sleep Diary and Stanford Sleepiness Scale
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
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Replacement, run by Koneksa Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Hip Assessment - In Clinic (time frame: Baseline Day 1 through Day 42 End of Participation). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.