Clinical trial NCT06184100: Virtual Self-Management Program for JIA
Official title: Feasibility and Acceptability of a Virtual Self-management Program - A Pilot Randomized Controlled Trial for Adolescents With Juvenile Idiopathic Arthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Keywords: Virtual
Education
Clinical Trial
JIA
Self-management Program
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
name: University of Toronto
name: University of Alberta
name: University of Manitoba
name: University of British Columbia
First posted: 2023-12-28
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Program Adherence Rates (feasability)
timeFrame: 3 months
measure: Satisfaction of Program
timeFrame: 3 months
measure: Intervention fidelity
timeFrame: 3 months
Secondary outcomes:
measure: Understanding of JIA
timeFrame: 3 months
measure: Understanding of Arthritis Self Efficacy
timeFrame: 3 months
measure: Quality of Life for Teens
timeFrame: 3 months
measure: Physical Pain Level
timeFrame: 3 months
measure: How Prepared the patient feels for Adult Care
timeFrame: 3 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
Study officials:
References: