Telemedicine for Psoriatic Arthritis

(PsOWell Trial)

Recruiting at 1 trial location

Overseen By Jessica Walsh, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Inability to consent, PsAID score ≤4, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

87 Participants Needed

Trial Summary

What is the purpose of this trial?

This will be a single-arm interventional study to test the acceptability, feasibility, and effectiveness of structured telemedicine visits to encourage lifestyle changes that will improve quality of life, disease impact, and disease activity in patients with psoriatic arthritis (PsA).

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you should be stable on your current therapy and not planning to switch treatments during the study.

What data supports the idea that Telemedicine for Psoriatic Arthritis is an effective treatment?

The available research shows that telemedicine can be effective for managing chronic conditions similar to Psoriatic Arthritis. For example, telehealth has been shown to improve care for patients with osteoarthritis and spinal pain by reducing pain intensity and disability. Additionally, telehealth has been beneficial for patients in remote areas with chronic neurological conditions by improving access to specialized care and reducing costs. These findings suggest that telemedicine could also be effective for Psoriatic Arthritis by providing better access to care and potentially improving patient outcomes. ^{1 2 3 4 5}

What safety data exists for telemedicine in treating psoriatic arthritis?

The research does not provide specific safety data for telemedicine in treating psoriatic arthritis. However, it highlights the potential benefits of telemedicine, such as improved access to healthcare, early diagnosis, and better disease management. Challenges include difficulties in diagnosing PsA without in-person examinations. The studies focus on the effectiveness and feasibility of telemedicine, but specific safety data is not detailed. ^{6 7 8 9 10}

Is telemedicine a promising treatment for psoriatic arthritis?

Yes, telemedicine is a promising treatment for psoriatic arthritis because it improves access to healthcare, allows for early diagnosis, and helps manage the disease more effectively. It can connect patients with specialists remotely, reducing delays in care and making it easier for patients to receive timely treatment. ^{7 8 11 12 13}

Research Team

Alexis Ogdie-Beatty, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for adults aged 18-89 with active psoriatic arthritis symptoms, stable on current therapy, and not planning to change treatment soon. Participants must be willing to follow study procedures, have a mobile device for telemedicine visits, and score over 4 on the PsAID questionnaire or patient global assessment.

Inclusion Criteria

I am willing and able to follow all study rules and attend all appointments.

I am not planning to change my current treatment plan.

Provision of signed and dated informed consent form

Exclusion Criteria

Inability to provide informed consent

My PsA symptoms are mild.

I plan to change my psoriasis or PsA treatment soon.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in structured telemedicine visits using PsOWellTM to encourage lifestyle changes for holistic management of psoriasis

24 months

Regular telemedicine visits

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 months

Treatment Details

Interventions

• Telemedicine

Trial Overview The study tests how well patients with psoriatic arthritis respond to structured telemedicine visits aimed at encouraging lifestyle changes. It will evaluate if these remote consultations can improve life quality and disease management effectively.

Participant Groups

Group I: Interventional Telemedicine Arm Experimental Treatment 1 Intervention

Single Arm Intervention

Telemedicine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Telemedicine for:

• General medical consultations
• Chronic disease management
• Urgent care needs

Approved in European Union as Telemedicine for:

• General medical consultations
• Chronic disease management
• Urgent care needs

Approved in Canada as Telemedicine for:

• General medical consultations
• Chronic disease management
• Urgent care needs

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Findings from Research

The eHealth intervention was delivered with high fidelity, with 93% of participants receiving initial training and 98.45% of expected follow-ups conducted, indicating strong program adherence.

Despite high engagement from 40.4% of users over 12 months, increased usage did not lead to significant improvements in clinical outcomes or lifestyle changes, suggesting that simply using the intervention more frequently does not guarantee better health results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-Based Intervention for Cardiovascular Disease Management Integrated With Primary Care Electronic Health Records: Mixed Methods Evaluation of Implementation Fidelity and User Engagement. Coorey, G., Peiris, D., Scaria, A., et al.[2021]

A study involving 27 participants with chronic low back disorders showed that a virtual care model using videoconferencing between nurse practitioners and physical therapists had diagnostic and management agreement similar to traditional in-person assessments.

The virtual model demonstrated strong concordance for urgent surgical referrals and recommendations for physical therapy follow-up, suggesting it can effectively enhance access to care for rural patients with chronic low back issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A physical therapist and nurse practitioner model of care for chronic back pain using telehealth: Diagnostic and management concordance. Lovo, S., Harrison, L., O'Connell, ME., et al.[2022]

A study involving 13 patients with chronic diseases showed that 100% reported satisfaction with their telehealth consultations, highlighting its effectiveness in providing access to specialized care.

Telehealth not only improved patient access to healthcare but also resulted in significant cost savings, with patients collectively saving nearly $17,000 in travel expenses and avoiding an average of 937 km of travel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of telehealth to remote and rural Australians with chronic neurological conditions. Le, S., Aggarwal, A.[2021]

A systematic review of 23 studies involving 4,994 participants found that telephone-based interventions, often combined with educational materials, significantly reduced pain intensity and disability in patients with osteoarthritis and spinal pain compared to usual care.

However, adding face-to-face components to telephone interventions did not provide any additional benefits over standard care, indicating that simple telephone-based support may be sufficient for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of telephone-based interventions for managing osteoarthritis and spinal pain: a systematic review and meta-analysis. O'Brien, KM., Hodder, RK., Wiggers, J., et al.[2022]

Internet-based rehabilitation programs significantly reduce pain in patients with knee osteoarthritis compared to conventional rehabilitation, based on a meta-analysis of 4 randomized controlled trials involving 791 patients.

However, these programs did not show a significant improvement in physical function over conventional rehabilitation, indicating that while they may help with pain management, further research is needed to enhance their overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Internet-Based Rehabilitation Programs on Improvement of Pain and Physical Function in Patients with Knee Osteoarthritis: Systematic Review and Meta-analysis of Randomized Controlled Trials. Xie, SH., Wang, Q., Wang, LQ., et al.[2021]

Patients with psoriasis (PsO) and psoriatic arthritis (PsA) who started treatment with apremilast via telehealth had similar medication adherence and persistence compared to those who initiated treatment in-person, indicating that telehealth can be an effective alternative for managing these conditions.

Among 505 patients studied, 54.3% achieved high adherence and 65.1% were persistent with their treatment over a 6-month follow-up, demonstrating that telehealth visits do not compromise treatment outcomes for apremilast.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apremilast Adherence and Persistence in Patients with Psoriasis and Psoriatic Arthritis in the Telehealth Setting Versus the In-person Setting During the COVID-19 Pandemic. Das, AK., Chang, E., Paydar, C., et al.[2023]

Telemedicine can significantly enhance access to healthcare for patients with psoriatic arthritis (PsA), helping to address issues of misdiagnosis and undiagnosed cases, which can lead to severe outcomes like joint damage.

Despite its benefits, diagnosing PsA through telemedicine poses challenges due to the need for thorough in-person examinations, highlighting the importance of optimizing telemedicine practices for effective management of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine and psoriatic arthritis: best practices and considerations for dermatologists and rheumatologists. Gottlieb, AB., Wells, AF., Merola, JF.[2022]

Psoriatic arthritis (PsA) can develop in up to 30% of psoriasis patients, often after unnoticed inflammation, making early identification crucial for effective treatment and potentially preventing the disease.

Digital health technologies, such as telemedicine and mobile apps, can enhance monitoring and early diagnosis of PsA in psoriasis patients, improving access to care and disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Approaches for a Reliable Early Diagnosis of Psoriatic Arthritis. Fagni, F., Knitza, J., Krusche, M., et al.[2021]

In a study of 131 patients with psoriatic arthritis (PsA), apremilast was primarily prescribed for those with oligoarticular PsA and significant comorbidities, often as a first-line treatment or after biologic failures.

After 6 months, 72.1% of patients continued treatment, with 40.3% achieving low disease activity or remission, indicating that apremilast is effective and has a safety profile consistent with clinical trials, despite some patients experiencing side effects like diarrhea and headaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective evaluation of patient profiling and effectiveness of apremilast in an Italian multicentric cohort of psoriatic arthritis patients. Favalli, EG., Conti, F., Selmi, C., et al.[2020]

This pilot study involving patients who underwent thumb carpometacarpal arthroplasty and reverse shoulder arthroplasty showed that telerehabilitation is feasible and can maintain patient satisfaction, with no significant differences in recovery outcomes compared to traditional in-person therapy.

Patients in the telerehabilitation group reported high satisfaction levels, suggesting that this approach could effectively support upper extremity recovery while potentially reducing costs and improving access to care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, effectiveness and patient satisfaction of telerehabilitation after thumb carpometacarpal arthroplasty and reverse total shoulder arthroplasty: A pilot study. Palm, KB., Blazar, PE., Manna, JC., et al.[2023]

A study involving 431 patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis showed that remote follow-up via telemedicine during the COVID-19 pandemic did not significantly differ in health outcomes compared to traditional in-person visits.

Despite 69.9% of scheduled visits being postponed, telemedicine proved effective, suggesting that many patients may prefer this method of care moving forward, especially during ongoing health crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of telemedicine during the COVID-19 pandemic in patients with inflammatory arthritis: a retrospective study on feasibility and impact on patient-reported outcomes in a real-life setting. Chevallard, M., Belloli, L., Ughi, N., et al.[2023]

Psoriatic arthritis is a challenging condition to diagnose due to its varying symptoms, which can range from mild to severe and progressive.

Effective care management for psoriatic arthritis involves understanding the objectives of treatment and the rationale behind the use of specific medications to address the inflammation and symptoms associated with the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psoriatic arthritis. Holdsworth, J.[2005]

Telemedicine, particularly teledermatology, is an effective alternative for managing chronic inflammatory conditions like psoriasis, allowing for accurate diagnosis and management through virtual evaluations and patient-provided images.

Integrating validated screening tools for psoriatic arthritis into teledermatology can enhance access to specialists and reduce delays in diagnosis and treatment, although it should complement rather than replace in-person visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Psoriasis Foundation Telemedicine Task Force guidance for management of psoriatic disease via telemedicine. Pelet Del Toro, N., Yahia, R., Feldman, SR., et al.[2023]

References

1. Canada pubmed.ncbi.nlm.nih.gov

An Internet-Based Intervention for Cardiovascular Disease Management Integrated With Primary Care Electronic Health Records: Mixed Methods Evaluation of Implementation Fidelity and User Engagement. [2021]

2. England pubmed.ncbi.nlm.nih.gov

A physical therapist and nurse practitioner model of care for chronic back pain using telehealth: Diagnostic and management concordance. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

The application of telehealth to remote and rural Australians with chronic neurological conditions. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of telephone-based interventions for managing osteoarthritis and spinal pain: a systematic review and meta-analysis. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Effect of Internet-Based Rehabilitation Programs on Improvement of Pain and Physical Function in Patients with Knee Osteoarthritis: Systematic Review and Meta-analysis of Randomized Controlled Trials. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Apremilast Adherence and Persistence in Patients with Psoriasis and Psoriatic Arthritis in the Telehealth Setting Versus the In-person Setting During the COVID-19 Pandemic. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Telemedicine and psoriatic arthritis: best practices and considerations for dermatologists and rheumatologists. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Digital Approaches for a Reliable Early Diagnosis of Psoriatic Arthritis. [2021]

9. Italy pubmed.ncbi.nlm.nih.gov

Retrospective evaluation of patient profiling and effectiveness of apremilast in an Italian multicentric cohort of psoriatic arthritis patients. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Feasibility, effectiveness and patient satisfaction of telerehabilitation after thumb carpometacarpal arthroplasty and reverse total shoulder arthroplasty: A pilot study. [2023]

11. Germany pubmed.ncbi.nlm.nih.gov

Use of telemedicine during the COVID-19 pandemic in patients with inflammatory arthritis: a retrospective study on feasibility and impact on patient-reported outcomes in a real-life setting. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Psoriatic arthritis. [2005]

13. United States pubmed.ncbi.nlm.nih.gov

National Psoriasis Foundation Telemedicine Task Force guidance for management of psoriatic disease via telemedicine. [2023]