Health TrialsbyHealthPanel

Virtual Self-Management Program for JIA

ConditionJuvenile Idiopathic Arthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorUniversity of Calgary

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Self-Management Program (SMP)

    Other intervention

    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

    Other intervention

    No intervention. Participant only receives standard of care.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: SMP Program with Standard CareExperimental treatment 1 intervention
Group B: Standard Care OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
3 months
2

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.

Time frame
3 months
3

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.

Time frame
3 months

Secondary outcomes

1

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 .

Time frame
3 months
2

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.

Time frame
3 months
3

Quality of Life for Teens

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

Time frame
3 months
4

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

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

The Hospital for Sick Children

Collaborator

University of Toronto

Collaborator

University of Alberta

Collaborator

University of Manitoba

Collaborator

University of British Columbia

Collaborator

Source ClinicalTrials.gov
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