Virtual Self-Management Program for JIA

A Pilot Randomized Controlled Trial: Feasibility and Acceptability of a Virtual Adolescent Self-management Program for Juvenile Idiopathic Arthritis

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.

Study Overview

• Status: Recruiting
• Conditions: Juvenile Idiopathic Arthritis
• Intervention / Treatment: Other: Virtual Self-Management Program (SMP); Other: No Intervention

Detailed Description

A pilot RCT will be conducted to evaluate the feasibility and preliminary effectiveness comparing the SMP intervention group with a wait-list control group receiving usual care. A total of 100 participants with confirmed JIA (ages 12 to 17) will be recruited from five Canadian pediatric rheumatology centres of different provinces and randomized in a 1:1 ratio to the control or intervention groups. Adolescents in the intervention group will receive the virtual SMP program in addition to standard of care. The intervention is a multifaceted program that includes JIA disease education, self-management strategies, and peer support. Four 60-90- minute sessions will be conducted over eight weeks with a group size of 4-6 participants. Both groups will receive usual care. Participants in the control group will be offered the SMP after completion of the post-control outcome measure. If participants choose to enroll in the SMP, the participants will be asked to complete outcome measures a second time upon completion of the program.

The primary objective is feasibility outcome that will be measured as adherence with the SMP Program (defined as 80% completion). Other feasibility outcomes will include:

(A) recruitment and withdrawal rates (>80% recruitment rate and <80% withdrawal); (B) proportion of completed questionnaires (C) engagement and satisfaction with the SMP program as measured through a semi-structured virtual interview with the participants following involvement in the SMP; (D) intervention fidelity (consistent content and technology delivery).

The secondary objective on preliminary effectiveness includes completion of five validated and reliable patient-reported outcome measures at two-time points: perceived ability to manage JIA (self-management), pain interference, self-efficacy, health-related quality of life (HRQL) and transition readiness. These questionnaires will include:

(A) Medical Issues, Exercise, Pain, and Social Support Questionnaire (MEPS), (B) Children's Arthritis Self-Efficacy Scale (CASES), (C) Pediatric Quality of Life Inventory 3.0 Rheumatology - Teen Module (Peds QL, (D) PROMIS Pediatric Pain Interference Scale (PROMIS) and RACER (Readiness for Adult Care in Rheumatology). Descriptive statistical methods and non-parametric tests will be used to analyze the data.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heinrike Schmeling, MD, PhD; Phone Number: 403-955-7698; Email: SchmelingResearch@albertahealthservices.ca
• Study Contact Backup: Name: Jessica Booth, BSc; Phone Number: 403-955-3194; Email: SchmelingResearch@albertahealthservices.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 6A8
      • Recruiting
      • Alberta Children's Hospital
      • Contact: Jessica Booth, BSc; Phone Number: 403-955-3194; Email: SchmelingResearch@albertahealthservices.cS
      • Principal Investigator: Heinrike Schmeling, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SMP Program with Standard Care; four 60-90 minute virtual educational sessions over 8 weeks with a group of 4-6 participants	Other: Virtual Self-Management Program (SMP); 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.
Active Comparator: Standard Care Only; Standard of care(no formal education program similar to SMP) and placed on 8-week waitlist for optional intervention.	Other: No Intervention; No intervention. Participant only receives standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Understanding of JIA	The medical issues, exercise, pain, and social-support [MEPS] questionnaire is a measure for perceived ability (e.g., knowledge, skill, behavior, attitudes, and self-efficacy) to manage JIA .	3 months
Understanding of Arthritis Self Efficacy	The Children's Arthritis Self-Efficacy Scale is a validated (e.g., concurrent validity, construct validity) and reliable (e.g., internal consistency) measure used for arthritis self-efficacy.	3 months
Quality of Life	The Pediatric Quality of Life Inventory 3.0 Rheumatology Teen Module is a validated (e.g. construct validity) and reliable (e.g., internal consistency) measure used for pediatric rheumatology specific health related quality of life in children aged 13-18	3 months
Physical Pain Level	The PROMIS Pediatric Pain Interference Scale is validated and reliable (e.g., internal consistency) measure for pain behavior in children aged 8-17	3 months
How Prepared the patient feels for Adult Care	Readiness for Adult Care in Rheumatology (RACER) questionnaire a reliable and validated instrument used to assess transition readiness in adolescents with JIA.	3 months

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: University of Manitoba; The Hospital for Sick Children; University of British Columbia; University of Alberta; University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 28, 2023

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: JIA; Clinical Trial; Virtual; Education; Self-management Program
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Juvenile
• Other Study ID Numbers: VISTA-JIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No