- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04844307
Comparing Inpatient COVID-19 Outcomes in 2 Different PT Dosing Groups (CCPT)
Comparing COVID-19 Inpatient Outcomes When Treated With a Twice-a-day 15- Minute PT Program Versus a Once-a-day-30-minute PT Program
연구 개요
상태
상세 설명
The 2019 pandemic struck New York City hospitals early and aggressively. In rehabilitating inpatients during the early part of the pandemic, we learned that many of them were too affected by the COVID-19 illness to be able to tolerate the typical 30-minute daily session of physical therapy. At that time, the physical therapy (PT) staff often accommodated patients by dividing the typical 30 minute daily session into two 15 minute sessions in an effort to increase patient tolerance and participation. However, it was discovered at that time that literature was scarce on whether these divided PT sessions were equal or superior to the typical sessions. Nor was there any substantial literature on whether shorter duration higher frequency sessions were better tolerated by the inpatient. The purpose of this prospective randomized non-blinded controlled study is to compare outcomes of COVID inpatients receiving one 30 minute daily session of PT to patients receiving two 15 minute daily sessions of PT.
In order to obtain high quality data on level of mobility during hospitalization, two separate scoring systems will be used: The AMPAC and JH-HLM scores. These two scoring systems have been selected for their wide acceptance in both the physiatry and physical therapy communities, and due to having confirmed inter-rater reliability and validity. These scores will be calculated by the physical therapist on initial evaluation, and then again on every session up until discharge. The physical therapy team at this community hospital have already received extensive education on the utilization of both of these scoring tools.
The rationale for this study is to determine whether shorter duration (15 minute) higher frequency sessions (2x a day) are better tolerated than the standard 30-minute session. We hypothesize that shorter duration higher frequency sessions are superior to standard inpatient PT sessions in terms of patient tolerance and change in mobility scores from admission to discharge. Supporting evidence is based on previous observation and from a recent survey given to 19 physical therapists actively working with COVID-19 inpatients at White plains Hospital: Healthier patients have a higher tolerance of the 30 minute sessions, and sicker patients have a poor tolerance of the 30 minute sessions.
연구 유형
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Ages 18-89.
- positive COVID19 status as confirmed by at least one positive nasopharyngeal/oropharyngeal swab or chest CT.
- PT referral placed and patient seen by PT within 72 hours of admission.
Exclusion Criteria:
- Patients who were deemed unable to actively participate in therapy due to poor cognitive status or being medically unstable.
- Patients who are unable to give consent.
- Patient who are bedbound at baseline.
- Patient who are not fluent in English or Spanish (a Spanish version of consent form will be made available)?
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Standard PT group
The standard PT group (control) will be receiving the standard 30 minute PT sessions 5 days a week.
There will be no variations from standard inpatient PT treatment except that subjects may receive more days of PT than patients who are not participating in study.
|
The standard PT session is 30 minutes once daily.
It routinely involves exercises designed to strengthen and increase mobility of the patient such as bed mobility, transfers, and ambulation.
In this study group there will be no variation from this standard treatment.
|
|
실험적: Divided session PT group
The divided session PT group (experimental) will be receiving 15 minute sessions twice a day, five days a week.
The total number of minutes of PT time per day/week will be identical to the standard PT group, but divided into shorter and more frequent sessions.
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The standard PT session (30 mins) will be divided into two 15 minute sessions spread out during the day.
Therefore, the total number of minutes of PT will not vary from the standard.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient tolerance
기간: Through completion of study, an average of 1 year
|
Patient tolerance will be recorded in minutes at end of each PT session in each group.
|
Through completion of study, an average of 1 year
|
|
Change in mobility scores from admission to discharge
기간: Through completion of study, an average of 1 year
|
Mobility scores including Activity Measure for Post Acute Care (AMPAC) and Johns Hopkins Highest Level of Mobility (JH-HLM) will be recorded at end of each PT session.
The change in scores from admission to discharge will be determined and recorded once patient is discharged.
|
Through completion of study, an average of 1 year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Disposition
기간: Through completion of study, an average of 1 year
|
Disposition possibilities include home, home with services, acute rehab, subacute rehab or skilled nursing facility, LTACH, transfer to another acute care hospital, hospice/home with hospice, expired.
|
Through completion of study, an average of 1 year
|
|
Hospital Length of Stay
기간: Through completion of study, an average of 1 year
|
Total length of stay in the hospital will be determined based on date of admission and date of discharge from acute care hospital.
|
Through completion of study, an average of 1 year
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Anupama Kurra, MD, Montefiore Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2021-12937
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
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