- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00951691
Enhanced Medical Rehabilitation for Disablement
Enhanced Acute Medical Rehabilitation for Disablement
연구 개요
상세 설명
Disabling medical events are common for elderly people, causing immobilization, requiring extensive rehabilitation, and generating fears of loss of function and need for institutionalization. Existing acute medical rehabilitation settings-skilled nursing facilities (SNFs) and inpatient rehabilitation facilities (IRFs)-often do not adequately meet the needs of depressed elders, resulting in a missed opportunity for effective and functional recovery. This study will test a new program that will enhance acute rehabilitation in SNFs to target mood, motivation, and functional recovery in the 2 to 4 weeks after hospitalization. This program, developed by the research team, increases the intensity and engagement of physical therapy (PT) and occupational therapy (OT).
Participation in this study will last until discharge from the SNF, with follow-up assessments lasting until 3 months after entry. Participants will be randomly assigned to receive either the enhanced acute medical rehabilitation or treatment as usual. Participants receiving the enhanced care will complete up to 3 hours of enhanced PT and OT per day from study entry until discharge, excluding weekends. Participants receiving treatment as usual will receive standard PT and OT. Study assessments will take place at baseline, after 8 and 15 days, and after discharge. Follow-up assessments will occur after 30, 60, and 90 days. Assessments will include questionnaires and interviews measuring positive and negative affect, and functional impairment and disability.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Missouri
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Saint Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Admitted to Barnes Extended Care nursing home
- Acute disablement
- (criterion dropped) Clinically depressive symptoms, including a score of 15 or greater on the Hamilton Depression Rating Scale (HAM-D) and depressed mood or anhedonia present more days than not since the fracture
Exclusion Criteria:
- Unable to provide informed consent due to dementia and severe persistent delirium
- Inability to cooperate with the protocol
- Cardiac or other medical instability that would preclude carrying out high intensity exercises
- Language, visual, or hearing barriers to participation
- Presence of pelvic fractures that do not involve the proximal femur
- Presence of metastatic cancer, including cancer that causes a pathological fracture
- Bilateral acute hip fractures
- Lifetime psychosis or mania
- Alcohol or substance dependence within 6 months, or current (prior to hip fracture) alcohol or substance abuse
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: 평소와 같이 치료
참가자는 평소와 같이 치료를 받게 됩니다.
|
Standard treatment with physical and occupational therapies
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실험적: Enhanced acute medical rehabilitation
Participants will receive enhanced acute medical rehabilitation.
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Daily up to 3-hour sessions of enhanced physical and occupational therapies (see Lenze et al, "Enhanced Medical Rehabilitation Increases Therapy Intensity and Engagement and Improves Functional Outcomes in Postacute Rehabilitation of Older Adults: A Randomized-Controlled Trial."
J American Medical Director's Association, 2012 for details and outcome data.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
functional recovery
기간: baseline, end of nursing home admission
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Barthel Index.
Secondary Measures are gait speed and 6 minute walk.
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baseline, end of nursing home admission
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
positive and negative affect
기간: Measured from baseline to SNF discharge
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13 items assessing positive and negative affect
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Measured from baseline to SNF discharge
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공동 작업자 및 조사자
수사관
- 수석 연구원: Eric J Lenze, MD, Washington University School of Medicine
간행물 및 유용한 링크
일반 간행물
- Hildebrand MW, Host HH, Binder EF, Carpenter B, Freedland KE, Morrow-Howell N, Baum CM, Dore P, Lenze EJ. Measuring treatment fidelity in a rehabilitation intervention study. Am J Phys Med Rehabil. 2012 Aug;91(8):715-24. doi: 10.1097/PHM.0b013e31824ad462.
- Lenze EJ, Host HH, Hildebrand MW, Morrow-Howell N, Carpenter B, Freedland KE, Baum CA, Dixon D, Dore P, Wendleton L, Binder EF. Enhanced medical rehabilitation increases therapy intensity and engagement and improves functional outcomes in postacute rehabilitation of older adults: a randomized-controlled trial. J Am Med Dir Assoc. 2012 Oct;13(8):708-12. doi: 10.1016/j.jamda.2012.06.014. Epub 2012 Aug 3.
- Handoll HH, Cameron ID, Mak JC, Panagoda CE, Finnegan TP. Multidisciplinary rehabilitation for older people with hip fractures. Cochrane Database Syst Rev. 2021 Nov 12;11(11):CD007125. doi: 10.1002/14651858.CD007125.pub3.
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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. .