Virtual Self-Management Program for JIA

University of Calgary

Status: Enrolling

Conditions: Juvenile Idiopathic Arthritis

Treatments: Other: Virtual Self-Management Program (SMP); Other: No Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06184100

VISTA-JIA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

SMP Program with Standard Care

Experimental group

Description:

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

Treatment:

Other: Virtual Self-Management Program (SMP)

Standard Care Only

Active Comparator group

Description:

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

Treatment:

Other: No Intervention