Positive Minds Strong Joints for Knee Osteoarthritis
NCT Number: NCT06493903
Acronym: PMSJ
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoarthritis, Knee
Interventions: BEHAVIORAL: Positive Minds, Strong Joints
Sponsor: Boston University Charles River Campus
Collaborators: Rheumatology Research Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-06-30

Summary:
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).

Primary Outcome Measures: Recruitment Rate, Number of participants randomized out of those screened, Throughout the recruitment process, up to 6 months.|Retention, Proportion of participants who complete patient-reported outcome surveys out of those randomized, From the start of the study to 12 weeks post intervention|Attendance, Proportion of participants that attended the intervention sessions in the PMSJ group, During 10 weeks intervention period
Secondary Outcome Measures: 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, It assesses depression symptoms. Each question is scored from 0 to 3 and the sum value of individual questions is the total score. 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. 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 10 (very uncertain) to 100 (very certain). Higher scores indicate greater self-efficacy to manage osteoarthritis., Baseline, week 10, and week 22|Knee osteoarthritis Treatment History, This survey collects information about the treatments the individual has undertaken for their knee osteoarthritis, Baseline, week 5, week 10, week 16 and week 22|Demographics, This survey a survey that collects information about participants characteristics such as race, ethnicity, education, employment status, and family income, Baseline|Comorbidities, This survey collects information on presence of other medical health conditions including heart disease, hypertension, diabetes, etc., Baseline|Fear Avoidance Beliefs Questionnaire - Physical Activity, This question focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their knee pain and resulting disability. Each item is scored from 0 to 6. Total scores are summation of each item scores. 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. It is scored by summing the ratings of its 13 items, each rated on a 5-point scale. 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, institutions, and the scientific process, rated on a Likert scale. 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 Likert scale. Higher scores indicate greater perceived social support across various domains., Baseline and week 10|International Physical Activity Questionnaire, It assesses physical activity levels in adults. IPAQ provides a standardized questionnaire that can be used globally to assess physical activity across diverse populations. The responses are converted into MET (Metabolic Equivalent of Task) minutes per week. The results categorize individuals into different levels of physical activity such as low, moderate and high, Baseline, week 10, week 22|Patient-Reported Outcomes Measurement Information System-sleep, It is used to measure measures various aspects of sleep quality, disturbances, and related daytime impacts., Baseline, week 10|Patient Global Impression of Change, Participant's rating of change in condition on a 7-point scale. Higher scores represent improvement, and lower scores represent worsening or no change in symptoms, Week 10, Week 22|Satisfaction survey, Self-designed questionnaire to determine the satisfaction of participants with the intervention, Week 10 and week 22|Feedback survey, A self-designed questionnaire aimed at collecting information about the entire study from participants, week 10 and week 22|Numerical Rating Scale-nominated activity, It is used to assess average rating of knee pain from 0-10, where 0 represents no pain and 10 represents worst pain imaginable, Weekly 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 mm scale. higher scores represent higher impact of disease or worse global health, Weekly start of intervention to week 22|Medication use, This questionnaire is used to assess the medication use of the participants, Weekly start of intervention to week 22|Adherence to exercise, This questionnaire is used to assess how participants adhere to exercise intervention, Weekly start of intervention to week 22|7-meter gait test, This is a functional measure use4d to assess the comfortable walking pace of participants as the walk 2 laps of a 7-meter path, Baseline and week 10