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| ID | Type | Description | Link |
|---|---|---|---|
| 19KACH009 | Other Identifier | Keller |
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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
| Uniformed Services University of the Health Sciences | FED |
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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).
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.
Hypothesis 2b: Intervention participants will demonstrate a reduction in recreational activities that place high load on the knee, as indicated by a mean decrease on Marx Activity Scale, that will be significantly larger than any decrease in the control group, immediately post-intervention and at 6- and 12-months post-intervention.
Specific Aim 3: Compare knowledge about osteoarthritis (OA) risk factors between groups pre- and post-intervention.
Hypothesis 3: The proportion of participants that demonstrate knowledge of osteoarthritis pre- and post-intervention will significantly increase in the intervention group compared to the control group post-intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
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| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mCare PTOA Intervention | Behavioral | The mCare PTOA intervention includes five evidence-based modules that focus on 1) basic joint health following injury, 2) self-management strategies, 3) weight management, 4) physical activity, and 5) occupational management. These educational modules will serve as the primary intervention in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Function | Knee Injury and Osteoarthritis Outcome Score (KOOS) | pre-intervention, immediately post-intervention (~6-weeks), 6-months Post Intervention, 12 months post intervention |
| Readiness to Manage Arthritis | Readiness to Manage Arthritis Questionnaire | pre-intervention, immediately post-intervention (~6 weeks), 6 months post-intervention, 12 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity | Marx Activity Rating | pre-intervention, immediately post-intervention (~ 6-weeks), 6 months post-intervention, 12 months post-intervention |
| OA Knowledge | OA Knowledge |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Function | WOMAC | pre-intervention, immediately post-intervention (~6-weeks), 6 months post-intervention, 12 months post-intervention |
| Measure of Intermittent and Constant Osteoarthritis Pain | ICOAP (Intermittent and Constant OA Pain) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth L Cameron, PhD | Keller Army Community Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keller Army Community Hospital | West Point | New York | 10996 | United States |
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| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| pre-intervention and immediately post-intervention (~6-weeks) |
| pre-intervention, immediately post-intervention (~6-weeks), 6 months post-intervention, 12 months post-intervention |