Evaluation of a Digital Perioperative Support Solution for Colorectal Surgery: Compliance and Impact on Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change, during the preoperative phase, of the psychological condition of the patients, assessed by the PHQ8 questionnaire scoring.
研究概览
简要总结
The Institute of Image-Guided Surgery (IHU) of Strasbourg develops new minimally invasive therapies, the benefit of which is maximized by an integrated approach to the care pathway (pre, per and postoperative).
Encouraging patient engagement in the process responds to its growing demand for information and consideration, enhances its care experience and clinical outcomes.
Medtronic has designed an digital solution for patient engagement (current name: "Get Ready") for scheduled colorectal surgery. The IHU is a pilot experiment site for this solution. This research protocol, of which the IHU is the promoter, aims at evaluating the use and the impact of this solution made available to the patients of the Hepato-Digestive Pole (PHD) of the New Civil Hospital.
The solution deployed at the Strasbourg IHU aims to improve the patient's preparation for his colorectal surgery and follow his rehabilitation after surgery, by reinforcing his compliance with existing protocols and enriching it with complementary practices.
The solution is not a medical device. It is limited to advice, monitoring and restitution of data declared by the patient; it is not intended to prevent, diagnose or treat the pathology; it is independent of any other medical device.
This study aims to assess the pre-operative impact of the solution, in terms of patients' adherence to the pre-operative program and correlations with their physical and psychological condition until their admission to surgery. The secondary purpose of the study is to precise the acceptability of the solution.
详细描述
The Institute of Image-Guided Surgery (IHU) of Strasbourg develops new minimally invasive therapies, the benefit of which is maximized by an integrated approach to the care pathway (pre, per and postoperative).
Encouraging patient engagement in the process responds to its growing demand for information and consideration, enhances its care experience and clinical outcomes. Patient engagement promotes accelerated rehabilitation and reduces complications and readmissions, which is also beneficial in terms of public health.
Medtronic has designed a digital solution for patient engagement (current name: "Get Ready") for scheduled colorectal surgery, for which the IHU is a pilot experiment site. This research protocol aims at evaluating the use and the impact of this solution made available to the patients of the Hepato-Digestive Pole (PHD) of the New Civil Hospital.
Multiple professionals dispense instructions and information to patients. The active accompaniment of the patient in his rehabilitation process is carried out mainly in the postoperative phase, during the hospital stay.
The solution deployed at the Strasbourg IHU aims to improve the patient's preparation for his colorectal surgery and follow his rehabilitation after surgery, by reinforcing his compliance with existing protocols and enriching it with complementary practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major patient candidate for a scheduled colorectal surgery and whose admission is expected within 8 days minimum
- •Patient with an email address and an internet connection
- •Patient able to receive and understand information about the study and give written informed consent
排除标准
- •Patient under the age of 18 years old.
- •Pregnant or lactating patient
- •Patient in exclusion period (determined by a previous or a current study)
- •Patient under guardianship, trusteeship or the protection of justice
结局指标
主要结局
Change, during the preoperative phase, of the psychological condition of the patients, assessed by the PHQ8 questionnaire scoring.
时间窗: At the start of the program (6 weeks before the surgery) and at the admission before the surgery
Positive correlations between compliance and improvement of the patient's condition will help demonstrate the value of the solution. The third part of the primary endpoint of the study is the correlation between the patient compliance and the evolution of the psychological condition assessed by the questionnaire PHQ8 (Brief "Patient Health Questionnaire" depression scale): questions the existence and intensity of depressive symptoms (score from 0 to 24 in case of severe depression).
Change, during the preoperative phase, of the psychological condition of the patients, assessed by GAD7 questionnaire scoring.
时间窗: At the start of the program (6 weeks before the surgery) and at the admission before the surgery
Positive correlations between compliance and improvement of the patient's condition will help demonstrate the value of the solution. The fourth part of the primary endpoint of the study is the correlation between the patient compliance and the evolution of the psychological condition evaluated by the questionnaire GAD7 ("Generalized Anxiety Disorder 7"-item): indicates the severity of the anxiety (score from 0 to 21 in case of generalized anxiety disorder)
Evaluation, during the preoperative phase, of patients' compliance to the program, assessed by a completeness rate.
时间窗: From the inclusion to the surgery
Positive correlations between compliance and improvement of the patient's condition will help demonstrate the value of the solution. The first part of the primary endpoint of the study is the average rate of completeness of the preoperative program: percentage based on the status (done / not done) of pre-operative tasks specific to each patient
Change, during the preoperative phase, of the physical condition of the patients, assessed by 6MTW scoring.
时间窗: At the start of the program (6 weeks before the surgery) and at the admission before the surgery
Positive correlations between compliance and improvement of the patient's condition will help demonstrate the value of the solution. The second part of the primary endpoint of the study is the correlation between the patient compliance and the evolution of the physical condition : comparison between two walk tests, one done at the inclusion, the other when admitted for surgery. The result of the walk test is the distance travelled in meters during the test (6 minutes) by the patient.
次要结局
- Evaluation of patients' compliance with their post-operative program(Everyday for 7 days after the discharge from hospital and on the 14th day after the discharge from hospital)
- Evaluation of the solution and its use by the patient(Visit Day 30)
- Evaluation of duration of hospital stays(from the day before the admission until the end of hospitalisation)
- Persistence of program compliance between pre- and post-operative phases(From the inclusion to the end of participation)
- Patient satisfaction regarding the program(2 days before the surgery and on the 14th day after the discharge from hospital)
- Evaluation, during the preoperative phase, of patient use of the program without compliance, assessed by a rate of undone activities(from 6 weeks before the surgery up to the surgery)
- Patient interactions with the help desk of the solution(from the inclusion to the end of participation)
- Evaluation of the solution and its use by health care providers(End of study)
- Evaluation of the postoperative complication rate(Visit Day 30)
- Evaluation of the number of postoperative critical values(7 days after the discharge of the hospital)