Ambulation to Improve Recovery With Wearable TECHnology (AIRTECH) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Clavien-Dindo postoperative morbidity (POM) score
研究概览
简要总结
This clinical trial evaluates the relationship between walking and sleeping habits and surgical outcomes in patients with lung cancer. Early walking after surgery is associated with decreased or less severe complications. Learning about how much patients walk may be important in improving outcomes after surgery. Information gained from this trial may help researchers develop interventions to improve outcomes after surgery and improve overall quality of life after surgery in patients with lung cancer.
详细描述
PRIMARY OBJECTIVE:
I. Estimate the difference between each Fitbit arm and a control arm in Clavien-Dindo Combined Postoperative Morbidity (POM) Score in the 30-day postoperative period.
SECONDARY OBJECTIVES:
I. For patients in Fitbit only arm (F0) and Fitbit integration arm (FB), evaluate the differences in steps regained at each postoperative day.
II. Quality of life before and after surgery using MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None (Participant, Care Provider)
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
- •18 years or older
- •English speaking
- •Ambulatory preoperatively
- •Patients undergoing at least a lobectomy
- •Must own a smart phone and be willing to install the Fitbit application (App)
- •Adequate internet connection via wifi or wireless network connection with smartphone
- •Patients who are not already using a wearable device to track daily steps
排除标准
- •Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study.
- •Cannot maintain activity monitor in place at the time of consent
- •Pregnant patients
研究组 & 干预措施
Arm I (usual care)
Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and early ambulation in the postoperative setting.
干预措施: Best Practice (Other)
Arm I (usual care)
Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and early ambulation in the postoperative setting.
干预措施: Quality-of-Life Assessment (Other)
Arm I (usual care)
Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and early ambulation in the postoperative setting.
干预措施: Questionnaire Administration (Other)
Arm II (usual care, Fitbit)
Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and early ambulation in the postoperative setting. Patients also receive a Fitbit to monitor step count
干预措施: Best Practice (Other)
Arm II (usual care, Fitbit)
Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and early ambulation in the postoperative setting. Patients also receive a Fitbit to monitor step count
干预措施: Medical Device Usage and Evaluation (Other)
Arm II (usual care, Fitbit)
Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and early ambulation in the postoperative setting. Patients also receive a Fitbit to monitor step count
干预措施: Quality-of-Life Assessment (Other)
Arm II (usual care, Fitbit)
Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and early ambulation in the postoperative setting. Patients also receive a Fitbit to monitor step count
干预措施: Questionnaire Administration (Other)
Arm III (usual care, Fitbit, Fitbit app)
Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and walking in the postoperative setting. Patients also receive a Fitbit device, install and use the Fitbit app on a smartphone. Postoperative step goals are as follows: Postoperative day (POD) 1: 25% of baseline. Subsequent days will be increased by 10% until patient reaches baseline daily step number. Five automatic daily reminders (delivered by the Fitbit Inspire HR^TM device itself) to meet a minimum of 250 steps an hour. Postoperatively, patients will be invited to participate in a private group with a leaderboard that consists of step numbers of other participants in the study in an anonymous fashion.
干预措施: Best Practice (Other)
Arm III (usual care, Fitbit, Fitbit app)
Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and walking in the postoperative setting. Patients also receive a Fitbit device, install and use the Fitbit app on a smartphone. Postoperative step goals are as follows: Postoperative day (POD) 1: 25% of baseline. Subsequent days will be increased by 10% until patient reaches baseline daily step number. Five automatic daily reminders (delivered by the Fitbit Inspire HR^TM device itself) to meet a minimum of 250 steps an hour. Postoperatively, patients will be invited to participate in a private group with a leaderboard that consists of step numbers of other participants in the study in an anonymous fashion.
干预措施: Health Promotion and Education (Other)
Arm III (usual care, Fitbit, Fitbit app)
Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and walking in the postoperative setting. Patients also receive a Fitbit device, install and use the Fitbit app on a smartphone. Postoperative step goals are as follows: Postoperative day (POD) 1: 25% of baseline. Subsequent days will be increased by 10% until patient reaches baseline daily step number. Five automatic daily reminders (delivered by the Fitbit Inspire HR^TM device itself) to meet a minimum of 250 steps an hour. Postoperatively, patients will be invited to participate in a private group with a leaderboard that consists of step numbers of other participants in the study in an anonymous fashion.
干预措施: Medical Device Usage and Evaluation (Other)
Arm III (usual care, Fitbit, Fitbit app)
Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and walking in the postoperative setting. Patients also receive a Fitbit device, install and use the Fitbit app on a smartphone. Postoperative step goals are as follows: Postoperative day (POD) 1: 25% of baseline. Subsequent days will be increased by 10% until patient reaches baseline daily step number. Five automatic daily reminders (delivered by the Fitbit Inspire HR^TM device itself) to meet a minimum of 250 steps an hour. Postoperatively, patients will be invited to participate in a private group with a leaderboard that consists of step numbers of other participants in the study in an anonymous fashion.
干预措施: Quality-of-Life Assessment (Other)
Arm III (usual care, Fitbit, Fitbit app)
Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and walking in the postoperative setting. Patients also receive a Fitbit device, install and use the Fitbit app on a smartphone. Postoperative step goals are as follows: Postoperative day (POD) 1: 25% of baseline. Subsequent days will be increased by 10% until patient reaches baseline daily step number. Five automatic daily reminders (delivered by the Fitbit Inspire HR^TM device itself) to meet a minimum of 250 steps an hour. Postoperatively, patients will be invited to participate in a private group with a leaderboard that consists of step numbers of other participants in the study in an anonymous fashion.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Clavien-Dindo postoperative morbidity (POM) score
时间窗: Up to 30 days after surgery
Two Bayesian probability and inferential models will be utilized: * Model 1: Inferential goals: Probability that POM score in the control arm is greater than F0 or FB arm: mean and 95% Credible Interval * Model 2: Baseline covariates adjusted analysis of model 1 * Performance status * FEV1 * Age * Open vs. Minimally invasive (0 is best, 5 is worst.) 0 - No postoperative complications 1. - Minor complication resolved without intervention 2. - complication requiring pharmaceutical intervention 3. - complication requiring surgical, endoscopic or radiological intervention, 4. - life-threatening complication requiring intensive care 5. - complication leading to the patient's death.
次要结局
- Hospital length of stay(Up to 30 days after surgery)
- Change in quality of life(Baseline to 30 days after surgery)
- Fitbit user experience (F0 and FB arm)(Up to 30 days after surgery)
- Differences in steps regained at each postoperative day (Fitbit only arm [F0] and Fitbit integration arm [FB])(Up to 30 days after surgery)
- Hospital readmission rate for lung surgery related events(Up to 30 days after surgery)
- Return of bowel function(Up to 30 days after surgery)
- Postoperative complications and step numbers(Up to 30 days after surgery)