Positive Minds Strong Joints for Knee Osteoarthritis
- Conditions
- Osteoarthritis, Knee
- Interventions
- Behavioral: Positive Minds, Strong Joints
- Registration Number
- NCT06493903
- Lead Sponsor
- Boston University Charles River Campus
- Brief 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).
- Detailed Description
In this feasibility RCT study, 40 Black Adults will be enrolled to either receive PMSJ or usual care. Participants who will take part in this research study will be in it for about 26 weeks. Participants in the PMSJ group will receive a one-hour individual session of psycho-education, 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 in this group will also continue to receive their usual care. Participants in the usual care will not receive any additional intervention from the researchers. All 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 be asked to wear a small movement sensor on their lower back. They will complete a remote assessment of their walking function while wearing this sensor and also wear this sensor for 7 days of continuous movement and physical activity monitoring. Feasibility of the intervention will be determined post-intervention by outcome measures such as recruitment rate, retention rate, and adherence.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Positive Minds Strong Joints Positive Minds, Strong Joints Participants in this group 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.
- Primary Outcome Measures
Name Time Method Retention From the start of the study to 12 weeks post intervention Proportion of participants who complete patient-reported outcome surveys out of those randomized
Recruitment Rate Throughout the recruitment process, up to 6 months. Number of participants randomized out of those screened
Attendance During 10 weeks intervention period Proportion of participants that attended the intervention sessions in the PMSJ group
- Secondary Outcome Measures
Name Time Method Feedback survey week 10 and week 22 A self-designed questionnaire aimed at collecting information about the entire study from participants
Comorbidities Baseline This survey collects information on presence of other medical health conditions including heart disease, hypertension, diabetes, etc.
Fear Avoidance Beliefs Questionnaire - Physical Activity Baseline and week 10 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
Knee Injury and Osteoarthritis Outcome Score Baseline, week 5, week 10, week 16 and week 22 Patient-reported outcome for knee pain and disability; a score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Patient Global Impression of Change Week 10, Week 22 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
Satisfaction survey Week 10 and week 22 Self-designed questionnaire to determine the satisfaction of participants with the intervention
Generalized anxiety 7-item scale Baseline, week 5, week 10, week 16 and week 22 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
Multidimensional Scale of Perceived Social Support Baseline and week 10 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.
Numerical Rating Scale-nominated activity Weekly start of intervention to week 22 It is used to assess average rating of knee pain from 0-10, where 0 represents no pain and 10 represents worst pain imaginable
Patient Global Assessment of Osteoarthritis Weekly start of intervention to week 22 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
7-meter gait test Baseline and week 10 This is a functional measure use4d to assess the comfortable walking pace of participants as the walk 2 laps of a 7-meter path
Trust in Medical Research Questionnaire Baseline and week 10 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
Patient-Reported Outcomes Measurement Information System-sleep Baseline, week 10 It is used to measure measures various aspects of sleep quality, disturbances, and related daytime impacts.
Adherence to exercise Weekly start of intervention to week 22 This questionnaire is used to assess how participants adhere to exercise intervention
Patient Health Questionnaire 9-item Baseline, week 5, week 10, week 16 and week 22 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
Arthritis Self Efficacy Scale Baseline, week 10, and week 22 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.
Knee osteoarthritis Treatment History Baseline, week 5, week 10, week 16 and week 22 This survey collects information about the treatments the individual has undertaken for their knee osteoarthritis
Demographics Baseline This survey a survey that collects information about participants characteristics such as race, ethnicity, education, employment status, and family income
Pain Catastrophizing Scale Baseline and week 10 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.
International Physical Activity Questionnaire Baseline, week 10, week 22 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
Medication use Weekly start of intervention to week 22 This questionnaire is used to assess the medication use of the participants