Recruiting

Virtual Self-Management

Sponsor:

University of Calgary

Code:

NCT06184100

Conditions

Juvenile Idiopathic Arthritis

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Virtual Self-Management Program (SMP)

No Intervention

Study Details

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

Study ID

NCT06184100

Start date

Dec 13, 2023

Status verified date

Oct, 2024

Completion date

Mar, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: SMP Program with Standard Care

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

active comparator: Standard Care Only

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

Interventions

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.

No Intervention

No intervention. Participant only receives standard of care.

Primary outcome measure

  • Program Adherence Rates (feasability) [ Time Frame: 3 months ]
  • Satisfaction of Program [ Time Frame: 3 months ]
  • Intervention fidelity [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Heinrike Schmeling, MD, PhD

403-955-7698SchmelingResearch@albertahealthservices.ca

Jessica Booth, BSc

403-955-3194SchmelingResearch@albertahealthservices.ca

Locations

Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Contacts

Jessica Booth, BSc

403-955-3194SchmelingResearch@albertahealthservices.cS

Principal Investigator:

Heinrike Schmeling, MD, PhD

More Information

Sponsor

University of Calgary

Last update posted

Dec 9, 2024

Last verified

Oct, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2024-12-09.