Virtual Self-Management Program for JIA

NCT06184100 | Recruiting

• 1 other identifier: VISTA-JIA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Juvenile Idiopathic Arthritis

Keywords

Virtual; Education; Clinical Trial; JIA; Self-management Program

Outcome Measures

Primary Outcomes (3)

• Program Adherence Rates (feasability)

  The primary objective is feasibility outcome that will be measured as adherence with the SMP Program. This is defined as Proportion of completed questionnaires (defined as 80% when all measures are completed) at baseline and 8 weeks post-randomization in both groups along with recruitment and withdrawal rates. (\>80% recruitment rate and \<80% withdrawal)

  3 months

• Satisfaction of Program

  Satisfaction with the SMP as measured through a semi-structured virtual interview with the participants following involvement in the SMP to capture participants' experience.

  3 months

• Intervention fidelity

  We are looking at consistent content and technology delivery. This will be assessed by i) Observational checklists ii) qualitative analysis of recorded video sessions after 2, 4 and at completion of all sessions by each facilitator to ensure sessions are consistently delivered and as planned.

  3 months

Secondary Outcomes (5)

• Understanding of JIA

  3 months

• Understanding of Arthritis Self Efficacy

  3 months

• Quality of Life for Teens

  3 months

• Physical Pain Level

  3 months

• How Prepared the patient feels for Adult Care

  3 months

Study Arms (2)

SMP Program with Standard Care

EXPERIMENTAL

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

Other: Virtual Self-Management Program (SMP)

Standard Care Only

ACTIVE COMPARATOR

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

Other: No Intervention

Interventions

Virtual Self-Management Program (SMP) OTHER

Four sessions, 60-90 minutes each, will be conducted over eight weeks with a group size of 4-6 participants via videoconferencing platforms such as Zoom or Microsoft Teams. Each session will include Power Point delivered presentations, interactive activities, and group discussions. This is a multifaceted program that includes JIA disease education, self-management strategies, and peer support.

SMP Program with Standard Care

No Intervention OTHER

No intervention. Participant only receives standard of care.

Standard Care Only

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents between the ages of 12 and 17
• Confirmed diagnosis within 2 years according to the International League of Associations for Rheumatology JIA classification criteria (2)
• Followed in one of the pediatric rheumatology clinics participating in the RCT
• Able to access the Internet on a computer
• Willing and able to complete online measures

You may not qualify if:

• Insufficient English reading and speaking skills
• Untreated psychiatric or comorbid disorders or major cognitive impairments leading to inability to understand materials and participate in the SMP group activities.
• Other chronic conditions such as other autoimmune disease, neurologic, orthopedics or other systems disorder (e.g. heart, kidney) that might influence outcome assessments
• Past participation in the last year or participating in another peer-support or self-management program

Sponsors & Collaborators

• University of Calgary: lead
• The Hospital for Sick Children: collaborator
• University of Toronto: collaborator
• University of Alberta: collaborator
• University of Manitoba: collaborator
• University of British Columbia: collaborator

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

RECRUITING

Related Publications (1)

• Booth J, Birnie KA, Chomistek K, Santana M, Stinson JN, Adebiyi BO, Brooks J, Guzman J, Hellweg R, Lim LS, Rumsey D, Feldman BM, Tagseth J, Wilson J, Schmeling H. A Virtual Self-Management Intervention for Adolescents With Juvenile Idiopathic Arthritis: Protocol for the VISTA-JIA Randomized Controlled Trial. JMIR Res Protoc. 2025 Jun 27;14:e69539. doi: 10.2196/69539.

  PMID: 40577780 DERIVED

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Heinrike Schmeling, MD, PhD

CONTACT

403-955-7698; SchmelingResearch@albertahealthservices.ca

Jessica Booth, BSc

CONTACT

403-955-3194; SchmelingResearch@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The research team and all participants will be aware which arm they are enrolled in throughout the study.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized into an interventional or control group. The control group will be given the option to receive the intervention after post-test outcome measures are recorded.

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: December 28, 2023
• Study Start: December 13, 2023
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)