A Digital Mindset Intervention to Improve Pain and Exercise Participation in Individuals With Knee Osteoarthritis: A Randomized, Parallel-group Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 458
- 试验地点
- 1
- 主要终点
- Change From Baseline in Knee Pain Measured by Numeric Pain Rating Scale
研究概览
简要总结
The aim of our clinical trial is to test if an online mindset intervention improves mindsets and physical activity levels more than an education intervention in individuals with knee osteoarthritis.
详细描述
Osteoarthritis affects 7% of the global population and is a leading cause of disability globally. Physical activity improves health outcomes, weight management, and knee function for people with knee osteoarthritis and should be considered first-line treatment. Yet, physical activity levels in this population are low compared to those without knee osteoarthritis.
Existing knowledge: Emerging research has highlighted the powerful influence of mindsets about exercise on engagement in physical activity. Mindsets are core assumptions about a domain or category that orient individuals to a particular set of attributions, expectations, and goals (a "meaning system"). In individuals with knee osteoarthritis, mindsets about the appeal of physical activity relate to future physical activity levels and one's chosen symptom management strategy, and mindsets about osteoarthritis relate to knee symptoms.
The investigators developed a digital mindset intervention to improve mindsets about exercise and osteoarthritis in individuals with knee osteoarthritis. The investigators piloted the intervention on 21 individuals with knee osteoarthritis throughout the United States. Participants improved in exercise and osteoarthritis mindsets. However, this was a small sample size, a control group was not used, and it was cross-sectional, thus, not able to evaluate changes in physical activity and osteoarthritis symptoms.
Need for a trial: A digital, low-cost, and, thus, scalable intervention to improve mindsets about osteoarthritis and exercise may improve pain and function and physical activity levels for the millions of individuals affected with knee osteoarthritis. A large randomized trial is therefore needed to evaluate if our mindset intervention leads to improvements in physical activity levels and osteoarthritis symptoms and, further, if these changes are due to more adaptive mindsets about exercise and osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Blind investigator and outcomes assessor: does not know group label
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 45 years of age
- •Self-reported doctor's diagnosis of knee osteoarthritis OR meets the National Institute for - - Health and Care Excellence osteoarthritis clinical criteria (activity-related knee pain and no knee morning stiffness lasting ≥ 30 minutes)
- •Knee pain for at least 3 months
- •Ability to walk unaided
- •Can read and write in English
- •Consistent internet access
- •Willingness and ability to comply with the study requirements
排除标准
- •Past total knee arthroplasty or scheduled surgical procedure on any back or lower limb with osteoarthritis within the next 12 months
- •Recent serious injury (within the past 2 months) on the knee(s) with osteoarthritis
- •Any condition making it unsafe to participate in physical activity
- •Intra-articular therapy within the past 6 months (e.g. injections such as corticosteroids and hyaluronic acid)
- •Participates in physical exercise for 30 minutes or more 5 days per week
研究组 & 干预措施
Active comparator group
A series of educational videos and reflective questions of the same duration and required attention as the mindset intervention program. The videos are sourced videos from YouTube that educate about osteoarthritis. The content consists of information about osteoarthritis that patients would typically receive if looking for more information about the disease, including disease pathology, risks, symptoms, and treatment strategies. The included videos contain factual content with a similar format to the mindset intervention videos, including live experts sharing information with animations and supplementary b-roll footage.
干预措施: Active comparator (Other)
Mindset intervention group
Four modules, each with a series of videos and reflective questions. Each module takes approximately 20-60 minutes to complete, with a total of about two hours to complete the entire program. Participants have one week to complete the program at their own pace. Participants are suggested to complete one module per day but are encouraged to go at the pace that works best for them.
干预措施: Mindset intervention (Behavioral)
Waitlist control group
This group will take the same surveys as the other groups at the same time points but will not receive any additional content.
结局指标
主要结局
Change From Baseline in Knee Pain Measured by Numeric Pain Rating Scale
时间窗: Change from Baseline at 1 month
Knee pain scored from 0 - 10 (0 being no pain and 10 being the worst pain)
Change From Baseline in Physical Activity Measured by Physical Activity Scale for the Elderly
时间窗: Change from Baseline at 1 month
The Physical Activity Scale for the Elderly (PASE) asks respondents about the frequency of light, moderate, and strenuous work and leisure activities and is a validated measure of self-reported physical activity for individuals with osteoarthritis. The scale is scored from 0 (no physical activity) to 793 (very high physical activity).
Change From Baseline in Mindset About the Process of Health - Physical Activity (MPH-Physical Activity) Scale
时间窗: Change from Baseline at Post-intervention (immediately following intervention completion)
The Process of Health Mindset -- Exercise measure is a one-factor scale developed and validated to assess mindset about the process of engaging in physical activity (e.g., physical activity is difficult/easy, unpleasant/pleasurable, boring/fun). The scale consists of 7 items scored from 1 to 4, with a higher score reflecting a more appeal-focused mindset about physical activity, and then averaged for a total score between 1 to 4.
Change From Baseline in Osteoarthritis Mindset by the Illness Mindset Inventory
时间窗: Change from Baseline at Post-intervention (immediately following intervention completion)
The Illness Mindset Inventory measures three mindsets about the nature and meaning of illness: that it is a catastrophe, manageable, or an opportunity. The scale consists of 20 items measured on a 6-point scale and scored from 1 to 6, with 10 of those questions capturing mindsets about osteoarthritis. The extent to which a participant endorses a particular mindset can be obtained by calculating the mean score for each mindset. A higher score indicates greater agreement with the mindset. The investigators adapted the scale to focus on mindsets about "knee osteoarthritis" as opposed to "chronic disease." There are three subscales, Osteoarthritis is Castrophic, Osteoarthritis is Manageable, and Osteoarthritis is Opportunistic. The questions pertaining to each subscale are averaged for a total score from 1 to 6 for each subscale.
次要结局
- Change From Baseline in Knee Osteoarthritis Knowledge by the Knee Osteoarthritis Knowledge Scale(Change from Baseline at Post-intervention (immediately following intervention completion))
- Change From Baseline in Knee Pain and Functioning by the Short Version of Western Ontario and McMaster Universities Arthritis Index (shortMAC)(Change from Baseline at 1 month)
- Change From Baseline in Perceived Need for Surgery by a Surgery Perception Question(Change from Baseline at 1 month)
- Change From Baseline in Symptom Management Strategy by an Osteoarthritis Symptom Management Question. The Variable is Reported as a % of Participants Who Reported Using the Symptom Management Strategy.(Change from Baseline at 1 month)
- Change From Baseline in Fear of Movement by the Brief Fear of Movement Scale for Osteoarthritis(Change from Baseline at 1 month)
- Change From Baseline in Arthritis Self-efficacy: Pain and Other Symptoms by the Arthritis Self-efficacy Pain and Other Symptoms Subscales(Change from Baseline at 1 month)
- Change From Baseline in Physical and Mental Health: Global Health: Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 - Global Health (Physical and Mental Health Sub-scales)(Change from Baseline at 1 month)
- Change From Baseline in Body Mindset by the Illness Mindset Inventory(Change from Baseline at Post-intervention (immediately following intervention completion))
- Change From Baseline in Adequacy Mindset by the Adequacy of Activity Mindset Measure(Change from Baseline at Post-intervention (immediately following intervention completion))
研究者
Melissa Boswell
Study Investigator
Stanford University