Efficacy of an Evidence-based Telehealth Intervention in Modifying Health Behavior
NCT ID: NCT07187024
Last Updated: 2025-09-22
Study Results
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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ACTIVE_NOT_RECRUITING
NA
65 participants
INTERVENTIONAL
2020-07-24
2026-09-01
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
54 Years
ALL
No
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Uniformed Services University of the Health Sciences
FED
Keller Army Community Hospital
FED
Responsible Party
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Kenneth Cameron
Director of Orthopaedic and Sports Medicine Research
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
Countries
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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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