بيتا
رادار التجارب AI
حالة التجربة السريرية NCT06003686 لـ إصابات الحبل الشوكي، السمنة، متلازمة القلب والأيض هي قيد التجنيد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا.
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
العودة إلى البحث

Spinal Cord Injury Model Systems (SCIMS) - Education Module

قيد التجنيد
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ 'رادار التجارب AI' أن يساعدك؛ ما عليك سوى النقر على 'وصف الدراسة' لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT06003686 هي دراسة تدخُّلية لـإصابات الحبل الشوكي، السمنة، متلازمة القلب والأيض وهي قيد التجنيد. بدأت في ٢٤ شعبان ١٤٤٥ هـ مع خطة لتجنيد ٢٥٠ مشاركًا. يقودها جامعة ميامي، ومن المتوقع اكتمالها بحلول ٢٠ جمادى الأولى ١٤٤٨ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١٣ ربيع الأول ١٤٤٧ هـ.
الملخص
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.
العنوان الرسمي

A Spinal Cord Injury (SCI) Stakeholder-vetted Education Module to Mitigate Early Cardioendocrine Health Risks Occurring After Spinal Cord Injuries.

الحالات الطبية
إصابات الحبل الشوكيالسمنةمتلازمة القلب والأيض
معرّفات دراسة أخرى
  • 20230202
NCT معرّف
NCT06003686
تاريخ البدء (فعلي)
2024-03-05
آخر تحديث مُنشور
2025-09-05
تاريخ الاكتمال (المقدر)
2026-10-31
عدد المشاركين المخطط لهم
٢٥٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
قيد التجنيد
الغرض الأساسي
وقاية
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
لا شيء (مفتوحة)
مجموعات/التدخلات
مجموعة المشاركين/مجموعةتَدَخُّل/علاج
تجريبيةParalyzed 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.
PVA Consumer Guide
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.
مقارن نشطWebMD 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.
ويب إم دي
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.
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
Change in Effectiveness of education modules as determined in the Knowledge Test
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
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
Change in Body Weight as determined by kilograms (kg)
Body weight will be measured in kilograms
baseline, up to 6 months
Change in Body composition as determined by Dual X-ray Absorptiometry (DXA)
Body composition will be measured in grams using DXA
baseline, up to 6 months
Change in Body composition as determined by Dual X-ray Absorptiometry (DXA) in Percentage
Body composition will be expressed as a percentage of body fat (BF) using DXA
baseline, up to 6 months
Change in sugar metabolism as determined by Insulin resistance (IR)
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
Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III
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
Change in Quality of Life (QoL) Using the International Spinal Cord Injury Basic Data Set
QoL values will be determined using a scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied).
baseline, up to 6 months
Change in heart disease risk as determined by cholesterol
Risk of heart disease will be measured from a blood sample in mg/dL
baseline, up to 6 months.
Change in heart disease risk as determined by blood pressure (BP)
BP will be measured in mmHg using an arm cuff
baseline, up to 6 months.
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
  1. Men and Women with SCI/D aged 18-70 years.
  2. Neurologically complete and incomplete American Spinal Injury Association (ASIA) Impairment scale (AIS) A-D spinal cord levels C5 and below.
  3. Enrolled no later than 4 months following discharge from initial rehabilitation from SCI.

  1. Pregnancy determined by urine testing in sexually active females.
  2. Cognitive impairment that compromises the legitimacy of consent.
  3. Grade 3-4 pressure injury at the time of study entry.
  4. Prisoners
University of Miami logoجامعة ميامي289 تجارب سريرية نشطة للاستكشاف
National Institute on Disability, Independent Living, and Rehabilitation Research logoNational Institute on Disability, Independent Living, and Rehabilitation Research
الجهة المسؤولة عن الدراسة
Gary Farkas, المحقق الرئيسي, Principal Investigator, University of Miami
جهة اتصال مركزية للدراسة
جهة اتصال: Patricia Graham, MS, 3052435119, [email protected]
3 مواقع الدراسة في 1 بلدان

District of Columbia

MedStar National Rehabilitation Network, Washington D.C., District of Columbia, 20010, United States
Ana Aguirre, جهة اتصال, 202-877-1875, [email protected]
Suzanne Groah, MD, المحقق الرئيسي
قيد التجنيد

Florida

University of Miami - Miami Project to Cure Paralysis, Miami, Florida, 33136, United States
Gary S Farkas, PhD, جهة اتصال, 305-243-4518, [email protected]
Patricia Graham, MS, CCRC, جهة اتصال, 305-243-5119, [email protected]
Gary J Farkas, PhD, المحقق الرئيسي
قيد التجنيد

Texas

Baylor Scott & White Institute for Research, Dallas, Texas, 75246, United States
Jacqueline Nguyen, MPH, جهة اتصال, (469) 831-5321, [email protected]
Simon Driver, PhD, المحقق الرئيسي
لم يبدأ التجنيد بعد