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

Not Applicable

Active, not recruiting

• Conditions: Post-traumatic Osteoarthritis; Knee Sprain; Knee Injuries

• Registration Number: NCT07187024
• Lead Sponsor: Keller Army Community Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2020-07-07
• Study Start: 2020-07-24
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-18
• Last Update Submitted: 2025-09-18
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Knee Function	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	pre-intervention, immediately post-intervention (~6 weeks), 6 months post-intervention, 12 months post-intervention	Readiness to Manage Arthritis Questionnaire

Secondary Outcome Measures

Name	Time	Method
Physical Activity	pre-intervention, immediately post-intervention (~ 6-weeks), 6 months post-intervention, 12 months post-intervention	Marx Activity Rating
OA Knowledge	pre-intervention and immediately post-intervention (~6-weeks)	OA Knowledge

Trial Locations

Locations (1)

Keller Army Community Hospital; 🇺🇸 West Point, New York, United States