Virtual Self-Management Program for Juvenile Arthritis

Overseen By Jessica Booth, BSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Untreated psychiatric, Autoimmune, Neurologic, others

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

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim of this project is to conduct a pilot randomized controlled trial (RCT) to evaluate the feasibility and preliminary effectiveness of a virtual group based self-management program (SMP) in adolescents with JIA across different provinces compared to a wait-list control group receiving only standard of care. Participants in the SMP group will partake in four 60-90 minute group sessions conducted over 8 weeks. The intervention is a multifaceted program that includes JIA disease education, self-management strategies, and peer support. Both the interventional and control group will be asked to complete baseline and post-test measures. Participants in the control group will be offered the SMP after completion of the post-control outcome measures.

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 seems focused on a self-management program rather than medication changes.

What data supports the effectiveness of the treatment Virtual Self-Management Program for Juvenile Arthritis?

Research shows that self-management programs, including internet-based ones, can improve health behaviors and outcomes for arthritis patients. Additionally, eHealth and mobile health interventions have been found to be effective in supporting the management of Juvenile Idiopathic Arthritis. ^{1 2 3 4 5}

Is the Virtual Self-Management Program for Juvenile Arthritis safe for humans?

The available research does not specifically address safety concerns, but self-management programs for juvenile arthritis, including virtual ones, are generally focused on providing information and support, which are typically safe for participants. ^{1 2 3 5 6}

How is the Virtual Self-Management Program for Juvenile Arthritis different from other treatments?

The Virtual Self-Management Program for Juvenile Arthritis is unique because it focuses on empowering young patients to manage their condition through online resources, providing disease information, self-management strategies, and social support, which is different from traditional treatments that often rely heavily on medication and in-person care. ^{1 2 3 4 7}

Eligibility Criteria

This trial is for adolescents with Juvenile Idiopathic Arthritis (JIA) who are interested in a virtual program to help manage their condition. Participants should be willing to attend online group sessions and complete certain health measures before and after the program.

Inclusion Criteria

I am between 12 and 17 years old.

Willing and able to complete online measures

Followed in one of the pediatric rheumatology clinics participating in the RCT

Exclusion Criteria

I have other chronic conditions that could affect my treatment results.

I do not have untreated mental health issues that prevent me from understanding or participating in group activities.

Past participation in the last year or participating in another peer-support or self-management program

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the SMP group partake in four 60-90 minute virtual group sessions over 8 weeks, including JIA disease education, self-management strategies, and peer support.

8 weeks

4 virtual group sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completion of outcome measures.

4 weeks

Optional SMP for Control Group

Participants in the control group are offered the SMP after completion of the post-control outcome measures.

8 weeks

Treatment Details

Interventions

• Virtual Self-Management Program (SMP)

Trial Overview The study is testing a Virtual Self-Management Program (SMP) that includes disease education, self-management strategies, and peer support over eight weeks, compared to standard care without this additional support.

Participant Groups

Group I: SMP Program with Standard Care Experimental Treatment 1 Intervention

four 60-90 minute virtual educational sessions over 8 weeks with a group of 4-6 participants

Group II: Standard Care Only Active Control 1 Intervention

Standard of care(no formal education program similar to SMP) and placed on 8-week waitlist for optional intervention.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

University of Manitoba

Collaborator

Trials

628

Recruited

209,000+

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Findings from Research

The self-management program (SMP) for adolescents with juvenile idiopathic arthritis (JIA) was found to be acceptable, with participants believing it would effectively support their self-management needs.

Feedback indicated that having a rheumatology health care provider facilitate the sessions would enhance trust in the information provided, and adjustments were made to the program based on participant suggestions to improve its content and format.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of an Adolescent Self-Management Program for Juvenile Idiopathic Arthritis. Chomistek, K., Barnabe, C., Naqvi, SF., et al.[2022]

The Internet-based Arthritis Self-Management Program (ASMP) significantly improved health status measures, including pain and disability, in patients with arthritis over a 1-year period, compared to usual care.

Despite the improvements in health status, the program did not lead to significant changes in health behaviors or healthcare utilization, indicating that while it helps with health outcomes, it may not influence how patients engage with their healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The internet-based arthritis self-management program: a one-year randomized trial for patients with arthritis or fibromyalgia. Lorig, KR., Ritter, PL., Laurent, DD., et al.[2022]

A qualitative study involving 25 participants (9 young people with Juvenile Arthritis, 8 parents or carers, and 8 healthcare professionals) found strong agreement on the need for a mobile app to support self-management of Juvenile Arthritis, emphasizing the importance of ownership and control for young users.

Key features desired for the app include interactive and engaging content, developmentally appropriate information, symptom monitoring, and access to social support, which could enhance the self-management experience for young people with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Young People's, Parents', and Professionals' Views on Required Components of Mobile Apps to Support Self-Management of Juvenile Arthritis: Qualitative Study. Waite-Jones, JM., Majeed-Ariss, R., Smith, J., et al.[2020]

A systematic review of 15 studies found that eHealth and mHealth interventions can effectively support symptom monitoring in children with juvenile idiopathic arthritis (JIA), particularly through real-time pain tracking, which is preferred over traditional recall methods.

While some interventions showed potential benefits in promoting physical activity and self-management, the overall evidence is limited and requires more rigorous research to confirm their long-term effectiveness and impact on health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of eHealth and mHealth Interventions Supporting Children and Young People Living With Juvenile Idiopathic Arthritis: Systematic Review and Meta-analysis. Butler, S., Sculley, D., Santos, D., et al.[2022]

The Teens Taking Charge Web-based self-management intervention significantly reduced pain intensity and pain interference in adolescents with juvenile idiopathic arthritis (JIA) compared to a Web-based education control, with effects lasting up to 12 months.

Participants in the intervention group also showed improved health-related quality of life (HRQL) related to pain and daily activities, indicating that the program effectively supports long-term health outcomes for adolescents with JIA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teens Taking Charge: A Randomized Controlled Trial of a Web-Based Self-Management Program With Telephone Support for Adolescents With Juvenile Idiopathic Arthritis. Stinson, JN., Lalloo, C., Hundert, AS., et al.[2020]

An online self-management program for adolescents with juvenile idiopathic arthritis (JIA) showed modest improvements in pain and health-related quality of life (HRQOL) over a 12-week period, with no significant differences compared to a control group receiving disease education.

Improvements in self-efficacy, emotional coping, and disease knowledge were linked to better pain and HRQOL outcomes, suggesting that these factors may play a role in managing JIA effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multisite Randomized Clinical Trial Evaluating an Online Self-Management Program for Adolescents With Juvenile Idiopathic Arthritis. Connelly, M., Schanberg, LE., Ardoin, S., et al.[2020]

The usability testing of the bilingual self-management program for adolescents with juvenile idiopathic arthritis (JIA) involved 19 participants (11 English-speaking and 8 French-speaking), revealing that both youth and parents found the program easy to navigate and understand, with no major usability issues identified after iterative testing.

Participants appreciated the interactive features of the program, such as discussion boards and video clips, which helped them feel supported in managing their condition, highlighting the program's effectiveness in meeting the unique needs of adolescents with JIA and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability testing of an online self-management program for adolescents with juvenile idiopathic arthritis. Stinson, J., McGrath, P., Hodnett, E., et al.[2021]

References

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

Acceptability of an Adolescent Self-Management Program for Juvenile Idiopathic Arthritis. [2022]

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

The internet-based arthritis self-management program: a one-year randomized trial for patients with arthritis or fibromyalgia. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Young People's, Parents', and Professionals' Views on Required Components of Mobile Apps to Support Self-Management of Juvenile Arthritis: Qualitative Study. [2020]

4. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness of eHealth and mHealth Interventions Supporting Children and Young People Living With Juvenile Idiopathic Arthritis: Systematic Review and Meta-analysis. [2022]

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

Teens Taking Charge: A Randomized Controlled Trial of a Web-Based Self-Management Program With Telephone Support for Adolescents With Juvenile Idiopathic Arthritis. [2020]

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

Multisite Randomized Clinical Trial Evaluating an Online Self-Management Program for Adolescents With Juvenile Idiopathic Arthritis. [2020]

7. Canada pubmed.ncbi.nlm.nih.gov

Usability testing of an online self-management program for adolescents with juvenile idiopathic arthritis. [2021]