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NCT Number: NCT07187024

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Post-traumatic Osteoarthritis Knee Injuries Knee Sprain Leg Injuries Wounds and Injuries

Age range

18 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keller Army Community Hospital

West Point, New York, 10996, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Knee Function

    Time frame: pre-intervention, immediately post-intervention (~6-weeks), 6-months Post Intervention, 12 months post intervention

    Knee Injury and Osteoarthritis Outcome Score (KOOS)

  2. Readiness to Manage Arthritis

    Time frame: pre-intervention, immediately post-intervention (~6 weeks), 6 months post-intervention, 12 months post-intervention

    Readiness to Manage Arthritis Questionnaire

Secondary outcomes

  1. Physical Activity

    Time frame: pre-intervention, immediately post-intervention (~ 6-weeks), 6 months post-intervention, 12 months post-intervention

    Marx Activity Rating

  2. OA Knowledge

    Time frame: pre-intervention and immediately post-intervention (~6-weeks)

    OA Knowledge

Other outcomes

  1. Knee Function

    Time frame: pre-intervention, immediately post-intervention (~6-weeks), 6 months post-intervention, 12 months post-intervention

    WOMAC

  2. Measure of Intermittent and Constant Osteoarthritis Pain

    Time frame: pre-intervention, immediately post-intervention (~6-weeks), 6 months post-intervention, 12 months post-intervention

    ICOAP (Intermittent and Constant OA Pain)

Sponsors and collaborators

Lead sponsor

Keller Army Community Hospital

Fed

Collaborators

  • Uniformed Services University of the Health Sciences
  • University of North Carolina, Chapel Hill

Registry information

Official study title

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

Acronym: MIRROR_14

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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