Post-traumatic OsteoarthritisMIRROR_14NCT07187024
Efficacy of an Evidence-based Telehealth Intervention in Modifying Health Behavior
A study testing mCare PTOA Intervention in people with Post-traumatic Osteoarthritis and Knee Sprain, run by Keller Army Community Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 54 years
- Conditions the study is for
- Post-traumatic Osteoarthritis, Knee Sprain, Knee Injuries
- What is being tested?
- mCare PTOA Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2020to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Keller Army Community Hospital
West Point, New York, 10996
About this study
Official title: Efficacy of an Evidence-based Telehealth Intervention in Modifying Health Behaviors Associated With Post-Traumatic Osteoarthritis
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).
Read the 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.
- Conditions
- Post-traumatic Osteoarthritis, Knee Sprain, Knee Injuries
- Being tested
- mCare PTOA Intervention
- Keywords
- Telehealth, Behavioral Intervention, PTOA
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mCare PTOA InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Function
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: pre-intervention, immediately post-intervention (~6-weeks), 6-months Post Intervention, 12 months post intervention
Readiness to Manage Arthritis
Readiness to Manage Arthritis Questionnaire
Measured: pre-intervention, immediately post-intervention (~6 weeks), 6 months post-intervention, 12 months post-intervention
Secondary outcomes (2)
Physical Activity
Marx Activity Rating
Measured: pre-intervention, immediately post-intervention (~ 6-weeks), 6 months post-intervention, 12 months post-intervention
OA Knowledge
OA Knowledge
Measured: pre-intervention and immediately post-intervention (~6-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start24 Jul 2020
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keller Army Community Hospital
- Sponsor type
- US federal agency
- Collaborators
- University of North Carolina, Chapel Hill, Uniformed Services University of the Health Sciences
- Responsible party
- Principal investigator, Kenneth Cameron, Keller Army Community Hospital
- Investigators
- Kenneth L Cameron, PhD, Principal investigator, Keller Army Community Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187024
- Sponsor's protocol ID
- RHC-A-19-034
- Other IDs
- 19KACH009
- Acronym
- MIRROR_14
- Status last verified
- Sep 2026
- First submitted
- 7 Jul 2020
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Evidence-based Telehealth Intervention in Modifying Health Behaviors Associated With Post-Traumatic Osteoarthritis
- ClinicalTrials.gov ID
- NCT07187024
- Acronym / sponsor ID
- MIRROR_14 / RHC-A-19-034
- Conditions
- Post-traumatic Osteoarthritis, Knee Sprain, Knee Injuries
- Keywords
- Telehealth, Behavioral Intervention, PTOA
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Keller Army Community HospitalUS federal agency
- Collaborators
- University of North Carolina, Chapel Hill, Uniformed Services University of the Health Sciences
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: mCare PTOA InterventionThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mCare PTOA InterventionThe 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. | Behavioural | Intervention |
Primary outcome
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)
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
2 secondary outcomes
Physical Activity
Time frame: pre-intervention, immediately post-intervention (~ 6-weeks), 6 months post-intervention, 12 months post-intervention
OA Knowledge
Time frame: pre-intervention and immediately post-intervention (~6-weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth L Cameron, PhD principal investigator
Keller Army Community Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mCare PTOA Intervention in people with Post-traumatic Osteoarthritis and Knee Sprain, run by Keller Army Community Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Function (time frame: pre-intervention, immediately post-intervention (~6-weeks), 6-months Post Intervention, 12 months post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.