- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04985409
Stepping Up: A Trial of Activity Monitoring Devices in Patients Undergoing Autologous Stem Cell Transplant
연구 개요
상세 설명
This study will enroll 20 subjects with a diagnosis of multiple myeloma or lymphoma (10 with each diagnosis) scheduled to undergo ASCT at Cedars-Sinai Medical Center.
After signing the informed consent form, intake data will be collected on all subjects will include age, diagnosis, Karnofsky performance status, and comorbidity index. Subjects will complete an SF-36 questionnaire that assesses their functional and emotional status. Each subject will undergo a 6-minute walk test (6MWT) while wearing a Fitbit monitor to record the number of steps taken. After admission, subjects will be randomly assigned to either the control or intervention group. Subjects in the control arm will receive an activity monitor but the physician, nurse, and patient will not receive any feedback from the device. Patients will be blinded to any data capture from their activity monitor. Participants in the intervention arm will receive an activity monitor and they will receive feedback from the activity tracker and the in-room TV screen. Study participants in this arm will engage with their physicians and nurses around achievement of daily step goals by viewing the in-room TV display of daily step counts on rounds. After discharge, all subjects will again complete the SF-36 questionnaire and perform a 6MWT at a routine clinic visit, within 30 days of the transplant procedure. Descriptive statistics in the form of mean and standard deviation will be used to summarize patient physical activity as measured by 6MWT.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90048
- Cedars-Sinai Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- diagnosis of multiple myeloma or lymphoma with plan to undergo autologous stem cell transplant
- at least 18 years of age
- English or Spanish speaking
- have access to an IOS or Android device
- able to provide informed consent.
Exclusion Criteria:
- pre-existing physical limitations which would preclude achievement of the ambulation goals
- inability to wear the activity monitor
- Jehovah's Witness patients enrolled in the bloodless transplant program are excluded as they require strict bed rest for long periods of time
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Feedback
Participants in the intervention arm will receive a Fitbit upon admission and will receive feedback from the activity tracker and the in-room TV screen as demonstrated by the Study Navigator.
Study participants in this arm will be engaging with their physicians around achievement of daily step goals by viewing the in-room TV display of their daily step counts on rounds.
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The system uses Sonifi health (TV content and visualizations) and Fitabase (3rd party server to process Fitbit data and export to Sonifi).
The system utilizes the patient's TVs to engage the patient and multidisciplinary team in monitoring ambulation status.
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간섭 없음: Control
Subjects in the control arm will receive a Fitbit upon admission for their transplant but neither the physician, nurse, nor patient will receive any feedback from the device.
They will be blinded to any data capture by their activity monitor.
Nurses and doctors will not monitor ambulation with the activity monitor, they will use standard methods to encourage ambulation.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Fitness measured by 6 minute walk test after discharge
기간: 3-4 weeks
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Standard 6 minute walk test will be performed
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3-4 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Fitness assessed by SF-36 questionnaire after discharge
기간: 3-4 weeks
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Standard SF-36 questionnaire will be completed
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3-4 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ron Paquette, MD, Cedars-Sinai Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Feedback에 대한 임상 시험
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Istituto Ortopedico Galeazzi모병수술 후 혈종, 고관절 치환술, 수술이탈리아
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Xuanwu Hospital, Beijingthe Alberto Santos Dumont Association for Research Support알려지지 않은