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

NCT ID: NCT07187024

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-24

Study Completion Date

2026-09-01

Brief Summary

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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).

Detailed Description

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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

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Post-traumatic Osteoarthritis Knee Sprain Knee Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

mCare PTOA Intervention

Intervention Type 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.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

Uniformed Services University of the Health Sciences

FED

Sponsor Role collaborator

Keller Army Community Hospital

FED

Sponsor Role lead

Responsible Party

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Kenneth Cameron

Director of Orthopaedic and Sports Medicine Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth L Cameron, PhD

Role: PRINCIPAL_INVESTIGATOR

Keller Army Community Hospital

Locations

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Keller Army Community Hospital

West Point, New York, United States

Site Status

Countries

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United States

Other Identifiers

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19KACH009

Identifier Type: OTHER

Identifier Source: secondary_id

RHC-A-19-034

Identifier Type: -

Identifier Source: org_study_id

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