입원 후 기능 회복을 개선하기 위한 HF 환자의 NMES (NeuHFRecover)
입원 후 기능 회복을 개선하기 위한 심부전 환자의 신경근 전기 자극(NeuHF-Recover)
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Vermont
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Burlington, Vermont, 미국, 05405
- University of Vermont Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 50-90세
- 입원 중 적극적으로 관리되는 HFpEF의 임상 진단
- 의료 센터에서 30마일 이내에 거주
- 정보에 입각한 동의를 수행할 수 있음
제외 기준:
- 류마티스 관절염 또는 기타 염증성/자가면역 질환
- 비 흑색 종 피부암 또는 저 등급 전립선 암을 제외한 암
- 중증 치매/알츠하이머병
- 말초 혈관 질환을 제한하는 운동
- 뇌혈관 사건과 관련된 신경근 질환 또는 신경근 기능 장애
- 체질량 지수 ≥40kg/m2
- 하지 혈전 또는 이식형 제세동기 또는 심박조율기
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 신경근 전기 자극
대퇴사두근의 신경근 전기 자극.
주 5일 45분
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양측 대퇴사두근 자극
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간섭 없음: 제어
처리 제어 없음
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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도보 6분 거리 (6MW)
기간: 퇴원(1일 이내)에서 퇴원 후 4주로 변경
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6MW는 폐 및 심장 질환 환자의 심폐 건강을 평가하기 위해 개발되었으며 심부전 환자에서 검증되었습니다.
표준 코스를 기준으로 6분 동안 환자가 걸을 수 있는 거리를 평가합니다.
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퇴원(1일 이내)에서 퇴원 후 4주로 변경
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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짧은 물리적 성능 배터리
기간: 퇴원(1일 이내)에서 퇴원 후 4주로 변경
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Short Physical Performance Battery는 균형, 보행 속도 및 의자에서 일어설 수 있는 능력을 평가하는 세 가지 작업으로 구성됩니다.
각 영역에 대한 척도의 단위는 총 점수 0-12에 대해 0-4 범위이며 점수가 높을수록 더 나은 신체 기능을 나타냅니다.
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퇴원(1일 이내)에서 퇴원 후 4주로 변경
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의학적 결과 약식 36
기간: 퇴원(1일 이내) 및 퇴원 후 4주
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Medical Outcomes Short Form 36은 자가 보고한 건강 및 신체 기능 상태를 평가하는 설문지입니다.
이 설문지에 포함된 건강의 8개 하위 영역을 반영하는 36개의 질문이 있습니다.
각 영역에 대한 점수는 각 하위 영역에 있는 질문의 가중 합계를 나타냅니다.
각 척도는 각 질문에 동일한 가중치가 적용된다는 가정하에 0-100 척도로 직접 변환됩니다.
이 측정값은 모든 하위 도메인에서 계산된 총 점수를 나타냅니다.
점수가 낮을수록 전반적인 건강 상태가 좋지 않음을 나타내고 점수가 높을수록 건강 상태가 양호함을 나타냅니다.
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퇴원(1일 이내) 및 퇴원 후 4주
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일상 생활 활동에서 Katz 독립 지수
기간: 퇴원(1일 이내) 및 퇴원 후 4주
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일반적으로 Katz ADL이라고 하는 일상 생활 활동의 Katz 독립 지수는 클라이언트가 독립적으로 일상 생활 활동을 수행할 수 있는 능력을 측정하는 기능적 상태를 평가하는 데 가장 적합한 도구입니다.
임상의는 일반적으로 일상 생활 활동을 수행하는 데 있어 문제를 감지하고 그에 따라 치료를 계획하기 위해 이 도구를 사용합니다.
이 지수는 목욕, 옷입기, 화장실 사용, 이동, 자제, 수유의 6가지 기능에서 수행의 적절성을 평가합니다.
클라이언트는 여섯 가지 기능 각각에서 독립성에 대해 예/아니오로 점수를 매깁니다.
6점은 완전한 기능, 4점은 중등도 장애, 2점 이하는 심각한 기능 장애를 나타냅니다.
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퇴원(1일 이내) 및 퇴원 후 4주
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Lawton Instrumental Activities of Daily Living (IADL) Scale
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. These skills are considered more complex than the basic activities of daily living as measured by the Katz Index of ADLs. The instrument is most useful for identifying how a person is functioning at the present time, and to identify improvement or deterioration over time. There are eight domains of function measured with the Lawton IADL scale. Women are scored on all 8 areas of function; historically, for men, the areas of food preparation, housekeeping, laundering have been excluded. Since men regularly complete food preparation, housekeeping, and laundering tasks, they were scored in all 8 domains as well. Clients are scored according to their highest level of functioning in that category. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and men. |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 1
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Responses to Q1.
In general, would you say your health is:
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 2
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Responses to Q2.
Compared to one year ago, how would you rate your health in general now?
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3a
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3a.
Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports.
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3b
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3b.
Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf.
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3c
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3c.
Lifting or carrying groceries.
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3d
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3d.
Climbing several flights ofstairs
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3e
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3e.
Climbing one flight of stairs
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3f
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3f.
Bending, kneeling, or stooping
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3g
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3g.
Walking more than a mile
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3h
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3h.
Walking several blocks
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3i
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3i.
Walking one block
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3j
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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The following items are about activities you might do during a typical day.
Does your health now limit you in these activities?
If so, how much?
Responses to Q3j.
Bathing or dressing yourself
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 4a
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health?
Responses to Q4a.
Cut down the amount of time you spent on work or other activities
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 4b
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health?
Responses to Q4b.
Accomplished less than you would like
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 4c
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health?
Responses to Q4c.
Were limited in the kind of work or other activities
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 4d
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health?
Responses to Q4d.
Had difficulty performing the work or other activities (for example, it took extra effort)
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 5a
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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During the past 4weeks, have you had any of he following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)?
Responses to Q5a.
Cut down the amount of time you spent on work or other activities
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 5b
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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During the past 4weeks, have you had any of he following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)?
Responses to Q5b.
Accomplished less than you would like
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 5c
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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During the past 4weeks, have you had any of he following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)?
Responses to Q5c.
Didn't do work or other activities as carefully as usual
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 6
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Responses to Q6.
During the past 4weeks, to what extent has your physical health or emotional problems interfered with your normal social activities with family, friends, neighbors or groups?
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 7
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Responses to Q7.
How much bodily pain have you had during the past four weeks?
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 8
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Responses to Q8.
During the past 4weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 9a
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9a. Did you feel full of pep? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 9b
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9b. Have you been a very nervous person? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 9c
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9c. Have you felt so down in the dumps that nothing could cheer you up? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 9d
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9d. Have you felt calm and peaceful? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 9e
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9e. Did you have a lot of energy? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 9f
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9f. Have you felt down hearted and blue? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 9g
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9g. Did you feel worn out? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 9h
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9h. Have you been a happy person? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 9i
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9i. Did you feel tired? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 9j
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9j. During the past 4weeks, how much of the time has your physical health or emotional problems interfered with your social activities (like visiting with friends, relatives, etc.)? |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 10a
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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How TRUE or FALSE is each of the following statements for you: Responses to Q10a. I seem to get sick a little easier than other people |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 10b
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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How TRUE or FALSE is each of the following statements for you: Responses to Q10b. I am as healthy as anybody I know |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 10c
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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How TRUE or FALSE is each of the following statements for you: Responses to Q10c. I expect my health to get worse |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 10d
기간: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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How TRUE or FALSE is each of the following statements for you: Responses to Q10d. My health is excellent |
Hospital discharge (Within 1 day) and 4-weeks post-discharge
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공동 작업자 및 조사자
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. .