An Open Label Data Collection Study of My Connect Post-Op, a Post-Operative Communication Tool
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 652
- 试验地点
- 4
- 主要终点
- Collect structured conversation logs
研究概览
简要总结
This open label, multi-center study will collect data from the participant's use of My Connect Post-Op Software as a post-operative communication solution in supporting patient recovery through Technology-Assisted Conversation (TAC). The application will be tested by patients who have undergone total joint replacement as a post-op communication tool. Data will be collected on how effectively the product guides patients through their recovery, identifying potential complications, and providing appropriate recommendations based on structured question pairs.
详细描述
Patients who are scheduled to undergo orthopedic total hip or total knee replacement surgery who meet the eligibility criteria will be enrolled in the study. Prior to surgery, participants will be trained on the use of the product and study requirements will be discussed. The training provides instructions at an in-office visit, outlining the device's usage. The instructions, along with warnings that the interface is with a computer and not a person, are emphasized in the device's app and user manual.
Daily prompts will interact with the patient, and the app will answer questions and direct specialized care/instructions. Participants will be instructed to engage with the software throughout the 30-day study period, responding to prompts and questions as the participant recovers from surgery. The software will log and archive all participants' interactions with the chatbot in the backend. Participants will be expected to utilize the investigational product after discharge and complete the 30-day study period.
For every active participant enrolled, a retrospective chart review patient from the same site will be enrolled in the study in a 1:1 manner. The retrospective review of approximately 200 patient's post-op clinical interactions will be collected as a control group for comparison.
An initial technical assessment of the application will be done with the first 10 active patients who have used the product for at least 2 weeks, focusing on the overall performance of the communication tool.
The primary objective of the study is to collect a structured conversation log, document product's decision-making patterns, and to ensure sufficient coverage of clinical scenarios.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Orthopedic patients scheduled for elective joint arthroplasty (single or double knee, or single or double hip replacement surgery).
- •Age 22-80 years. Owns a smart phone. Speaks and understands written and spoken English. Ability to give written informed consent.
排除标准
- •Known diagnosis of a psychiatric disorder. Known opioid dependence in the Investigator's opinion that may complicate participation.
- •Participation in another clinical trial investigating a drug, medical device, or a medical procedure in the 30 days preceding trial inclusion and throughout the duration of the trial.
- •Any condition that in the Investigator's opinion may complicate or preclude the subject from participating in this trial, such as physical impairment or noncooperation
研究组 & 干预措施
Adults undergoing total hip or knee replacement surgery
The entire active group will be utilizing the MyConnect Post Op communication tool.
干预措施: post op communication software (Device)
结局指标
主要结局
Collect structured conversation logs
时间窗: From enrollment to the end of treatment at 4 weeks
Collect conversations between the participant and the clinically conversant AI
次要结局
未报告次要终点