Efficacy of an Evidence-based Telehealth Intervention in Modifying Health Behaviors Associated With Post-Traumatic Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Knee Function
研究概览
简要总结
The overall objective of this study is to evaluate the efficacy of the mare telehealth intervention platform and the intervention on patients' readiness to manage osteoarthritis and patient reported outcomes. To accomplish the stated objectives the investigators will conduct a randomized controlled trial. The independent variable will be group (Intervention vs. Control) and the dependent variables will be patient reported knee status (SA1) and readiness to manage arthritis measures (SA2a), as well as activity level (SA2b). We will also compare knowledge about post-traumatic osteoarthritis (PTOA) between groups prior to and following the intervention (SA3).
详细描述
The Specific Aims of this project are:
Specific Aim 1: Compare the change in patient reported outcomes for knee pain, knee symptoms, and lack of vigorous knee function, from pre-intervention to immediately post-intervention and 6 and 12 months post-intervention, between the intervention group and the control group.
Hypothesis 1: From pre-intervention to post-intervention and 6 and 12 months post-intervention, significant decreases in knee pain, knee symptoms, and lack of vigorous knee function will be observed in the intervention group. However, there will be no significant decreases in these outcomes for control participants.
Specific Aim 2: Compare the proportion of participants that demonstrate changes on intermediate outcomes (increased readiness to manage PTOA and decreased knee loads from discretionary physical activity), from pre-intervention to immediately post-intervention and 6 and 12 months post-intervention, between the intervention group and the control group.
Hypothesis 2a: The proportion of participants that demonstrate an improvement in readiness to manage PTOA risk factors, as indicated by a one-step change on the Readiness to Manage Arthritis Questionnaire, will be significantly higher in the intervention group than in the control group, at 6 and 12 months post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current or former United States Military Academy (USMA) cadet or active duty service member who has had at least one Anterior Cruciate Ligament (ACL) surgery
排除标准
- •Do not have access to a personal mobile device (tablet or smart phone)
- •Are less than 6 months post-surgery
- •Known deployment within the next 12 months that would remove them from connectivity with a telehealth application for more than 3 months
- •Have not been cleared for full unrestricted return to activity/duty post ACL reconstruction
研究组 & 干预措施
Intervention
The participants randomized to the intervention arm will be assigned to the mCare PTOA application, which consists of five modules that include basic information on joint health following injury, self-management strategies, weight management strategies, physical activity recommendations, and occupational management strategies to optimize joint health. These modules are delivered through the mCARE platform to a secure application on the participant's mobile device, provide interactive educational content on PTOA risk factors and strategies to mitigate those factors.
干预措施: mCare PTOA Intervention (Behavioral)
Control
The participants randomized to the control arm will receive standard care treatment but will not be exposed to the intervention. In addition to the baseline data collection they will complete online surveys at 6±2 weeks (Post-intervention), 6±1 month, and 12±2 months post study enrollment.
结局指标
主要结局
Knee Function
时间窗: pre-intervention, immediately post-intervention (~6-weeks), 6-months Post Intervention, 12 months post intervention
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Readiness to Manage Arthritis
时间窗: pre-intervention, immediately post-intervention (~6 weeks), 6 months post-intervention, 12 months post-intervention
Readiness to Manage Arthritis Questionnaire
Knee Function
时间窗: pre-intervention, immediately post-intervention (~6-weeks), 6-months Post Intervention, 12 months post intervention
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Readiness to Manage Arthritis
时间窗: pre-intervention, immediately post-intervention (~6 weeks), 6 months post-intervention, 12 months post-intervention
Readiness to Manage Arthritis Questionnaire
次要结局
- Physical Activity(pre-intervention, immediately post-intervention (~ 6-weeks), 6 months post-intervention, 12 months post-intervention)
- OA Knowledge(pre-intervention and immediately post-intervention (~6-weeks))
- Physical Activity(pre-intervention, immediately post-intervention (~ 6-weeks), 6 months post-intervention, 12 months post-intervention)
- OA Knowledge(pre-intervention and immediately post-intervention (~6-weeks))
研究者
Kenneth Cameron
Director of Orthopaedic and Sports Medicine Research
Keller Army Community Hospital