Walking After Surgery to Improve Recovery and Outcomes After Surgery, AIRTECH Study
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Best Practice, Health Promotion and Education, Medical Device Usage and Evaluation, Quality-of-Life Assessment.
- Кому может быть актуально
- Состояния в реестре: Lung Carcinoma. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Ambulation to Improve Recovery With Wearable TECHnology (AIRTECH) Study
Обзор
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.
Подробное описание
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).
III. Hospital length of stay. IV. Hospital readmission rate within 30 days for lung surgery related events. V. Return of bowel function. VI. Postoperative complications and step numbers. VII. Fitbit user experience in the FB arm.
EXPLORATORY OBJECTIVES:
I. Sleep disturbances. II. Cost analysis.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: 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.
ARM II: 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.
ARM III: 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.
After completion of study intervention, patients are followed up at postoperative clinic and at 30 days after surgery.
Вмешательства
- Другое Best Practice
Receive usual care - Другое Health Promotion and Education
Install and use Fitbit app - Другое Medical Device Usage and Evaluation
Use Fitbit to monitor step count - Другое Quality-of-Life Assessment
Ancillary studies - Другое Questionnaire Administration
Ancillary studies
Первичные конечные точки
- Clavien-Dindo postoperative morbidity (POM) score [Срок оценки: Up to 30 days after surgery]
Вторичные конечные точки (7)
- Differences in steps regained at each postoperative day (Fitbit only arm [F0] and Fitbit integration arm [FB]) [Срок оценки: Up to 30 days after surgery]
- Change in quality of life [Срок оценки: Baseline to 30 days after surgery]
- Hospital length of stay [Срок оценки: Up to 30 days after surgery]
- Hospital readmission rate for lung surgery related events [Срок оценки: Up to 30 days after surgery]
- Return of bowel function [Срок оценки: Up to 30 days after surgery]
- Postoperative complications and step numbers [Срок оценки: Up to 30 days after surgery]
- Fitbit user experience (F0 and FB arm) [Срок оценки: Up to 30 days after surgery]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- M D Anderson Cancer Center — Houston
Идентификаторы
NCT: NCT04783168 · 2020-0453 · NCI-2020-14126 · 2020-0453