Telehealth Intervention for Osteoarthritis

(MIRROR_14 Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Keller Army Community Hospital

Disqualifiers: No mobile device, Recent surgery, Deployment, Not cleared for activity

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new telehealth platform called mCare, part of the mCare PTOA Intervention, to assist individuals in managing osteoarthritis, particularly after surgery for a torn ACL, a major knee injury. Participants will use an app that provides information and strategies for joint health, weight management, and physical activity. The researchers aim to determine if this app improves participants' readiness and ability to manage their arthritis and knee health. It is suitable for current or former U.S. Military Academy cadets or service members who have undergone ACL surgery and have access to a smartphone or tablet. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance post-surgery recovery and arthritis management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this telehealth intervention is safe for osteoarthritis patients?

A previous study found the mCare PTOA Intervention to be a well-tolerated method for managing joint health and osteoarthritis. This program includes educational lessons delivered through a secure app on a mobile device, providing information on joint health, self-care, weight management, and physical activity.

Research has shown that educational and self-care strategies, like those in the mCare PTOA app, are generally safe. They aim to improve understanding and readiness to manage osteoarthritis without causing harm. No specific reports of negative effects have emerged from using the mCare PTOA platform. Since this is not a medication or surgical treatment, the risk of side effects remains low.

Overall, the mCare PTOA Intervention appears safe for individuals seeking to better manage their osteoarthritis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for osteoarthritis, which typically involves medications, physical therapy, and sometimes surgery, the mCare PTOA intervention is delivered through a mobile app. This app offers a set of five interactive modules that educate users about joint health, provide self-management and weight management strategies, recommend physical activities, and offer occupational management tips. Researchers are excited about this approach because it empowers patients to manage their condition actively and conveniently from their mobile devices, potentially improving adherence and outcomes without the need for frequent doctor visits.

What evidence suggests that the mCare PTOA Intervention is effective for managing osteoarthritis?

Studies have shown that online programs can help reduce pain and improve movement in people with osteoarthritis. Research indicates that programs focusing on self-care, exercise, and weight management effectively manage knee osteoarthritis. In this trial, participants in the intervention arm will receive the mCare PTOA Intervention, which includes these strategies. Early results suggest that digital health tools can enhance understanding of joint health and improve osteoarthritis symptom management. By providing interactive educational content, the mCare platform aims to empower individuals to take control of their condition. ^{6 7 8 9 10}

Who Is on the Research Team?

Kenneth L Cameron, PhD

Principal Investigator

Keller Army Community Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with knee-related health issues such as osteoarthritis or knee injuries. Participants should be interested in managing their condition and able to use telehealth technology. Specific eligibility details are not provided, but typically include age range, overall health status, and the severity of knee conditions.

Inclusion Criteria

I am or was in the US military and have had ACL surgery.

Exclusion Criteria

I had surgery less than 6 months ago.

I haven't been fully cleared to return to all activities after ACL surgery.

Do not have access to a personal mobile device (tablet or smart phone)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention group use the mCare PTOA application, which includes modules on joint health, self-management, weight management, physical activity, and occupational strategies.

6 weeks

Delivered through mobile application

Control

Participants in the control group receive standard care treatment and complete online surveys.

6 weeks

Online surveys

Follow-up

Participants are monitored for changes in knee function, readiness to manage arthritis, physical activity, and OA knowledge at 6 and 12 months post-intervention.

12 months

Online surveys at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• mCare PTOA Intervention

Trial Overview The study is testing a telehealth intervention called mCare PTOA Intervention aimed at improving patients' ability to manage osteoarthritis and enhancing patient-reported outcomes. It's a randomized controlled trial comparing an intervention group with a control group on various measures including knee status, readiness to manage arthritis, activity level, and knowledge about post-traumatic osteoarthritis.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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 II: Control Active Control 1 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 Is Running the Clinical Trial?

Keller Army Community Hospital

Lead Sponsor

Trials

16

Recruited

2,100+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10952211/

A Cluster Randomized Controlled Trial - PMC - PubMed Central Our results showed that a new primary care model of service delivery (PARTNER) for knee OA led to a modest improvement in function and a small improvement in ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2665913125000585

MonitOring the health trajectory of patients with kNee ... This study will provide real world insights into the burden, treatment pathways, and health trajectories of people with knee osteoarthritis presenting to ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/msc.1465

Outcomes of a conservative care program for knee ... The intervention aim is to apply organized conservative components of care for knee osteoarthritis in an evidence-based management program ...

4. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-020-03339-6

Osteoarthritis physical activity care pathway (OA-PCP) This study collected preliminary data on an intervention to enhance to PA among individuals with OA, designed for delivery in a primary care ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7903254/

Effectiveness of Internet-Based Exercises Aimed at Treating ... Patients receiving the internet-based program experienced decreased pain and improved function at 6 weeks vs the usual care group. Meaning.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1521694222000699

Osteoarthritis today: Lost in translation? Osteoarthritis (OA) is a highly prevalent joint disease that is associated with pain, loss of function, and high direct and indirect economic costs.

7. researchgate.net researchgate.net/publication/382713706_Posttraumatic_osteoarthritis_after_athletic_knee_injury_A_narrative_review_of_diagnostic_imaging_strategies

Posttraumatic osteoarthritis after athletic knee injury In this review, we provide an overview of imaging modalities used to evaluate PTOA among athletes and physically active individuals following ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06096259

Study Details | NCT06096259 | Preventing Injured Knees ... This study is being done to find out if metformin is effective at reducing pain by delaying the onset of post-traumatic osteoarthritis (PTOA) after anterior ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6323612/

Towards prevention of post-traumatic osteoarthritis: report ... An evidence review on acute knee injury interventional studies to prevent PTOA was presented to the group, alongside overviews of challenges in this area.

10. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25725392/

Outcomes associated with early post-traumatic ... This study provides preliminary evidence that youth/young adults following sport-related knee injury report more symptoms and poorer function.