An Observational Study to Explore Twenty-Four Seven Functional Status Measures in Total Hip Replacement (LEARNT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Overall Hip Assessment - In Clinic
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Overall Hip Assessment - In Clinic
时间窗: Baseline Day 1 through Day 42 End of Participation
Harris Hip Score
Motor Function Assessments via Koneksa Application
时间窗: Baseline Day 1 through Day 42 End of Participation
Gait (20 second walk test)
Mobile Vital Signs via Mobile Blood Pressure Cuff
时间窗: Baseline Day 1 through Day 42 End of Participation
Orthostatic blood pressure
Daily Measurements via Wrist-worn Device
时间窗: 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
时间窗: 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
Quality of Life Patient Reported Questionnaire Scores
时间窗: 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
Participant Diary via Koneksa Application
时间窗: Baseline Day 1 through Day 42 End of Participation
Pain level likert scale, pain medication use, walking aid use
Sleep Electronic Patient Reported Outcomes
时间窗: Baseline Day 1 through Day 42 End of Participation
Sleep Diary and Stanford Sleepiness Scale
Clinician Reported Adverse Events
时间窗: 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)
Additional Questionnaire via Koneksa Platform
时间窗: 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
次要结局
未报告次要终点