NCT07187024

Efficacy of an Evidence-based Telehealth Intervention in Modifying Health Behavior

Efficacy of an Evidence-based Telehealth Intervention in Modifying Health Behaviors Associated With Post-Traumatic Osteoarthritis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Keller Army Community Hospital · Federal
• Sex: All
• Age: 18 Years – 54 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Post-traumatic Osteoarthritis
• Knee Sprain
• Knee Injuries

Interventions

Type	Name	Description
BEHAVIORAL	mCare PTOA Intervention	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.

Timeline

• Start date: 2020-07-24
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2025-09-22
• Last updated: 2025-09-22

Locations

1 site across 1 country: United States