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

NCT07187024 | Active Not Recruiting

• 2 other identifiers: RHC-A-19-03419KACH009
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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).

Conditions

Post-traumatic Osteoarthritis; Knee Sprain; Knee Injuries

Keywords

Telehealth; Behavioral Intervention; PTOA

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• 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)

Other Outcomes (2)

• Knee Function

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

• Measure of Intermittent and Constant Osteoarthritis Pain

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

Study Arms (2)

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.

Behavioral: mCare PTOA Intervention

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.

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Keller Army Community Hospital: lead
• University of North Carolina, Chapel Hill: collaborator
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Keller Army Community Hospital

West Point, New York, 10996, United States

Location

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Kenneth L Cameron, PhD

  Keller Army Community Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Orthopaedic and Sports Medicine Research

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: September 22, 2025
• Study Start: July 24, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)