척수 손상 모델 시스템(SCIMS) - 교육 모듈
척수 손상 후 발생하는 초기 심장 내분비 건강 위험을 완화하기 위한 척수 손상(SCI) 이해관계자 심사 교육 모듈.
The purpose of this study is to find out if receiving education regarding increased risks of cardiometabolic disease helps subjects understand these risks and how these risks participants' health.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Patricia Graham, MS
- 전화번호: 3052435119
- 이메일: pgraham1@med.miami.edu
연구 장소
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20010
- 모집하지 않고 적극적으로
- MedStar National Rehabilitation Network
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Florida
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Miami, Florida, 미국, 33136
- 모집하지 않고 적극적으로
- University of Miami - Miami Project to Cure Paralysis
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Texas
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Dallas, Texas, 미국, 75246
- 모병
- Baylor Scott & White Institute for Research
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수석 연구원:
- Simon Driver, PhD
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연락하다:
- Jacqueline Nguyen, MPH
- 전화번호: (469) 831-5321
- 이메일: Jacqueline.Nguyen@BSWHealth.org
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Men and Women with SCI/D aged 18-70 years.
- Neurologically complete and incomplete American Spinal Injury Association (ASIA) Impairment scale (AIS) A-D spinal cord levels C5 and below.
- Enrolled no later than 4 months following discharge from initial rehabilitation from SCI.
Exclusion Criteria:
- Pregnancy determined by urine testing in sexually active females.
- Cognitive impairment that compromises the legitimacy of consent.
- Grade 3-4 pressure injury at the time of study entry.
- Prisoners
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Paralyzed Veterans of America (PVA) Cardio-Metabolic Disease (CMD) Consumer Guide Group
Hard paper copy of as well as an electronic copy of the guide will be provided to subjects and study staff will provide a general review of the contents of the guide with subjects during their education sessions. Participants will be in this group for 6 months. |
Subject's will receive education on the PVA consumer guide 3 times over the course of the study. Each session will be approximately 10-15 minutes and will consist of a general review of the nutrition, exercise, and general healthy living guidelines content included. |
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활성 비교기: WebMD Group
Subjects will be introduced to WebMD and its contents. A brief document will be provided that includes site summary and website. Study staff will provide a very brief overview of the site. Participants will be in this group for 6 months. |
Subject's will receive education on how to navigate the WebMD site and find information on health, exercise and nutrition 3 times over the course of the study. Each session will be approximately 10-15 minutes and will consist of a general review of the health and wellness content available on the website. At study completion, subjects in this group will be provided with the PVA guide and a brief orientation of the nutrition, exercise, and general healthy living guidelines content included in the guide. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Effectiveness of education modules as determined in the Knowledge Test
기간: baseline, up to 6 months
|
Effectiveness as determined by the number of correct answers on the Knowledge Test where the higher number of correct answers indicates increased knowledge of the information provided. |
baseline, up to 6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Body Weight as determined by kilograms (kg)
기간: baseline, up to 6 months
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Body weight will be measured in kilograms |
baseline, up to 6 months
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Change in Body composition as determined by Dual X-ray Absorptiometry (DXA)
기간: baseline, up to 6 months
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Body composition will be measured in grams using DXA |
baseline, up to 6 months
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Change in Body composition as determined by Dual X-ray Absorptiometry (DXA) in Percentage
기간: baseline, up to 6 months
|
Body composition will be expressed as a percentage of body fat (BF) using DXA |
baseline, up to 6 months
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Change in sugar metabolism as determined by Insulin resistance (IR)
기간: baseline, up to 6 months
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Sugar metabolism will be determined as IR calculated using the formula (fasting serum glucose*fasting serum insulin/22.5). Lower values indicate a higher degree of insulin sensitivity. Fasting values are obtained from blood samples |
baseline, up to 6 months
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Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III
기간: baseline, up to 6 months
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A composite score will be obtained to assess change in QoL using a six-point Likert scale. Scores for satisfaction section range from "1- very satisfied" to "6-very dissatisfied". On the important section scoring ranges from "1-very important" to "6- very unimportant" |
baseline, up to 6 months
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Change in Quality of Life (QoL) Using the International Spinal Cord Injury Basic Data Set
기간: baseline, up to 6 months
|
QoL values will be determined using a scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied). |
baseline, up to 6 months
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Change in heart disease risk as determined by cholesterol
기간: baseline, up to 6 months.
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Risk of heart disease will be measured from a blood sample in mg/dL |
baseline, up to 6 months.
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Change in heart disease risk as determined by blood pressure (BP)
기간: baseline, up to 6 months.
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BP will be measured in mmHg using an arm cuff |
baseline, up to 6 months.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Gary Farkas, PhD, University of Miami
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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. .