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رادار التجارب AI
حالة التجربة السريرية NCT06493903 (PMSJ) لـ التهاب المفاصل العظمي في الركبة 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
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Positive Minds Strong Joints for Knee Osteoarthritis (PMSJ)

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 NCT06493903 (PMSJ) هي دراسة تدخُّلية لـالتهاب المفاصل العظمي في الركبة وهي قيد التجنيد. بدأت في ١٨ شعبان ١٤٤٦ هـ مع خطة لتجنيد ٤٠ مشاركًا. يقودها جامعة بوسطن، ومن المتوقع اكتمالها بحلول ٢١ رجب ١٤٤٨ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١٨ ذو القعدة ١٤٤٦ هـ.
الملخص
The aim of this research study is to test the feasibility of a physical and mental health intervention (Positive Minds, Strong Joints or PMSJ) for Black adults with knee osteoarthritis (OA).
وصف مفصل
In this feasibility study, at least 20 and up to 40 Black Adults will be enrolled to receive PMSJ intervention. Participants who will take part in this research study will be in it for about 26 weeks. Participants will receive a one-hour individual session of psychoeducation, mindfulness, and cognitive behavior therapy skills for 10 weeks via a HIPAA-protected zoom video-call or over the telephone. In addition, they will receive a community-based group exercise and pain education program once a week for 10 weeks. Participants will also continue to receive their usual care. Participants will be asked to take surveys at five time points (i.e.) before the start of the 10-week intervention (baseline visit), mid-way through the intervention (week 5), end of the 10-week intervention (post-intervention), 6 weeks after the intervention (week 16) and 12 weeks after the intervention (week 22). Brief surveys will also be completed weekly throughout the study. The surveys will be about pain, function, quality of life, mood, social support, sleep, etc. At baseline and post-intervention visits, all participants will also be asked to wear a small movement sensor on their lower back for 7 days of continuous movement and physical activity monitoring. During both of these 7-day periods, participants will complete a single remote assessment of their walking. Feasibility of the intervention will be determined post-intervention by outcome measures such as recruitment rate, retention rate, and adherence.
العنوان الرسمي

Physical and Mental Health Intervention for Black Adults With Knee Osteoarthritis: A Feasibility Study

الحالات الطبية
التهاب المفاصل العظمي في الركبة
المنشورات
مقالات علمية وأوراق بحثية منشورة حول هذه التجربة السريرية:
معرّفات دراسة أخرى
  • PMSJ
  • 7517
NCT معرّف
NCT06493903
تاريخ البدء (فعلي)
2025-02-17
آخر تحديث مُنشور
2025-05-16
تاريخ الاكتمال (المقدر)
2026-12-30
عدد المشاركين المخطط لهم
٤٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
قيد التجنيد
الكلمات الرئيسية
chronic pain
depression
anxiety
exercise
cognitive behavioral therapy
Black adults
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
غ/م
نموذج التدخل
المجموعة الواحدة
التعمية
لا شيء (مفتوحة)
مجموعات/التدخلات
مجموعة المشاركين/مجموعةتَدَخُّل/علاج
تجريبيةPositive Minds Strong Joints
Participants will receive an individual mental health intervention through a zoom video-call once a week for 10 weeks and a community-based group exercise intervention once a week for 10 weeks.
Positive Minds, Strong Joints
In this10-week physical and mental health intervention, participants will receive recommended exercise intervention and evidence-based mental health intervention for pain, depression and anxiety.
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
Recruitment Rate
Number of participants enrolled out of those screened
Throughout the recruitment process
Retention
Proportion of participants who complete patient-reported outcome surveys at 10 week timepoint
From the start of the study to end of the 10 week intervention
Attendance
Proportion of participants that attended at least 80% of intervention sessions
During 10 weeks intervention period
Satisfaction with treatment
Custom 2-item (0-10 scale) to determine satisfaction with individual components of the intervention (i.e., Positive Minds, Strong Joints). There are 2 items and each item is scored separately. Higher scores for each item mean greater satisfaction for that dimension.
week 10 and week 22
Participant Feedback
Custom survey asking the participants to provide feedback on a 5-point scale from very poor to excellent on various aspects of the intervention including content, interventionists, group aspects, overall rating, etc.
week 10 and week 22
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
Knee Injury and Osteoarthritis Outcome Score
Patient-reported outcome for knee pain and disability; a score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Baseline, week 5, week 10, week 16 and week 22
Patient Health Questionnaire 9-item
9-item questionnaire assessing depression symptoms. Each question is scored from 0 to 3 where higher scores indicate higher frequency of experiencing depressive symptoms. Total score is the sum of individual item scores. Score range is 0-27. Higher total scores indicate greater severity of depression
Baseline, week 5, week 10, week 16 and week 22
Generalized anxiety 7-item scale
It assesses anxiety symptoms. Each question is scored from 0 to 3 and the sum value of individual questions is the total score with range form 0-21. Higher total scores indicate greater severity of anxiety
Baseline, week 5, week 10, week 16 and week 22
Arthritis Self Efficacy Scale
It measures confidence in one's capacity to function despite pain. Scores range from 1 (very uncertain) to 10 (very certain). It has three subscales of pain, function, and other symptoms calculated as average of items contributing to that subscale. Higher scores indicate greater self-efficacy to manage osteoarthritis.
Baseline, week 10, and week 22
Fear Avoidance Beliefs Questionnaire - Physical Activity
4-item questionnaire to determine how one's fear avoidance beliefs contributes to the cognitive/affective part of their knee pain. Each item is scored from 0 to 6. Total scores are summation of each item scores. Range is 0-24. Higher total scores indicate greater fear of physical activity
Baseline and week 10
Pain Catastrophizing Scale
Questionnaire for a person's thought and feeling about pain. The questionnaire has 3 subscales namely rumination, magnification and helplessness. Each question is rated on a 5-point scale, from 0 (not at all) to 4 (always). It is scored by summing the ratings of its 13 items with a range of 0-52. Higher scores indicate greater pain catastrophizing tendencies in response to pain.
Baseline and week 10
Trust in Medical Research Questionnaire
It assesses participants' trust in medical research. It includes items related to confidence in researchers, and the scientific process, rated on a 5 Likert scale (strongly disagree, disagree, neutral, agree and strongly agree) with a total score range of 0-48. Higher scores indicate greater trust in medical research
Baseline and week 10
Multidimensional Scale of Perceived Social Support
It measures perceived social support from family, friends, and significant others. It consists of 12 items rated on a 7- Likert scale for a total score range from 12-84. Higher scores indicate greater perceived social support across various domains.
Baseline and week 10
International Physical Activity Questionnaire
It assesses physical activity levels across diverse populations. The responses are converted into MET (Metabolic Equivalent of Task) minutes per week. The results can be continuous or categorized. For the categorized results, individuals' physical activity categorized as low, moderate and high
Baseline, week 10, week 22
Patient-Reported Outcomes Measurement Information System-sleep
It is used to measure measures perceived sleep quality, difficulty in sleep and having enough and refreshing sleep. The 8 questions are rated on a 5-point scale. The scores are summed together with a raw score of from 8 to 40. The raw scores are then converted to standardized T-scores using conversion tables.
Baseline, week 10
Patient Global Rating of Change
This is a single item questionnaire with 15 options ranging from a very great deal worse to a very great deal better.
Week 10, Week 22
Numerical Rating Scale-nominated activity
average rating of knee pain from 0-10, where 0 represents no pain and 10 represents worst pain imaginable, in the past week in a nominated activity selected at baseline
Weekly from start of intervention to week 22
Patient Global Assessment of Osteoarthritis
It assesses participant's assessment of impact of osteoarthritis on their general health on a 0-100 scale. 0 is very poor and 100 is very well.
Weekly start of intervention to week 22
Adherence to exercise
This questionnaire is used to assess participants adhere to exercise. Participants document their engagement in unsupervised exercise throughout the week by noting minutes of exercise per day of the week
Weekly from start of intervention to week 22
gait speed
A known distance of20-28 meters divided by time taken to walk this distance in m/s
Baseline and week 10
Physical Activity Stages of change (short form)
It assesses participants readiness to engage physical activity. It consists of five stages which include Precontemplation, contemplation, preparation, action and maintenance.
Baseline and week 10
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
50 Years
الجنس المؤهل
الكل
  • Age≥50
  • BMI ≤ 40 kg/m2
  • Self-identify as Black (including African American)
  • Knee pain ≥4/10 on a 11 numeric scale over the past week
  • Scored 5 or more on either the Patient Health Questionnaire (PHQ-9) and/or the Generalized Anxiety Disorder 7-item Scale (GAD-7)
  • Can speak and understand English at a sufficient level to understand the study procedures and informed consent
  • Available for study duration
  • Able to attend remote sessions

  • Knee, hip or ankle replacement
  • Intra-articular corticosteroid or hyaluronic acid knee injection within 3 months
  • Knee surgery within past 6 months
  • Currently receiving or received within 3-months any PT for knee OA
  • Currently receiving or received within 3 months any mental health intervention (excluding pharmacologic treatments)
  • Planning to initiate physical therapy for joint or low back pain in the next 3months
  • Planning to initiate any mental health treatment (excluding pharmacologic treatments) in the next 1 month.
  • Systemic inflammatory arthritis (e.g., rheumatoid arthritis)
  • Neurologic conditions (e.g., stroke, Parkinson's disease, etc.)
  • Contraindications to starting an exercise program.
  • Suspected substance abuse
  • Lack capacity to consent
  • Pregnancy (self-report)
  • Participation in another clinical trial for any joint or muscle pain
  • Planning for a major surgery in the next 6 months
  • Having high risk mental health symptoms (active suicidality, bipolar disorder, mania, psychosis, schizophrenia)
  • Receiving chemotherapy or radiation therapy for cancer (except non-melanoma skin cancer)
Boston University Charles River Campus logoجامعة بوسطن280 تجارب سريرية نشطة للاستكشاف
Rheumatology Research Foundation logoRheumatology Research Foundation
الجهة المسؤولة عن الدراسة
Deepak Kumar, المحقق الرئيسي, Associate Professor, Boston University Charles River Campus
جهة اتصال مركزية للدراسة
جهة اتصال: Deepak Kumar, PhD,PT, 617-358-3037, [email protected]
جهة اتصال: Hosea Boakye, MPH, PT, 6173588142, [email protected]
1 مواقع الدراسة في 1 بلدان

Massachusetts

Boston University, Boston, Massachusetts, 02215, United States
قيد التجنيد