Virtual Self-Management Program for JIA
- Conditions
- Juvenile Idiopathic Arthritis
- Interventions
- Other: Virtual Self-Management Program (SMP)Other: No Intervention
- Registration Number
- NCT06184100
- Lead Sponsor
- University of Calgary
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- Willing and able to complete online measures
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SMP Program with Standard Care Virtual Self-Management Program (SMP) four 60-90 minute virtual educational sessions over 8 weeks with a group of 4-6 participants Standard Care Only No Intervention Standard of care(no formal education program similar to SMP) and placed on 8-week waitlist for optional intervention.
- Primary Outcome Measures
Name Time Method Program Adherence Rates (feasability) 3 months 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)
Intervention fidelity 3 months 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.
Satisfaction of Program 3 months Satisfaction with the SMP as measured through a semi-structured virtual interview with the participants following involvement in the SMP to capture participants' experience.
- Secondary Outcome Measures
Name Time Method Understanding of JIA 3 months 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 .
Understanding of Arthritis Self Efficacy 3 months 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.
Quality of Life for Teens 3 months 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
Physical Pain Level 3 months The PROMIS Pediatric Pain Interference Scale is validated and reliable (e.g., internal consistency) measure for pain behavior in children aged 8-17
How Prepared the patient feels for Adult Care 3 months Readiness for Adult Care in Rheumatology (RACER) questionnaire a reliable and validated instrument used to assess transition readiness in adolescents with JIA.
Trial Locations
- Locations (1)
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada