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| Name | Class |
|---|---|
| The Hospital for Sick Children | OTHER |
| University of Toronto | OTHER |
| University of Alberta | OTHER |
| University of Manitoba |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMP Program with Standard Care | Experimental | four 60-90 minute virtual educational sessions over 8 weeks with a group of 4-6 participants |
|
| Standard Care Only | Active Comparator | Standard of care(no formal education program similar to SMP) and placed on 8-week waitlist for optional intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Self-Management Program (SMP) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 months |
| 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. | 3 months |
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 . | 3 months |
| Understanding of Arthritis Self Efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heinrike Schmeling, MD, PhD | Contact | 403-955-7698 | SchmelingResearch@albertahealthservices.ca | |
| Jessica Booth, BSc | Contact | 403-955-3194 | SchmelingResearch@albertahealthservices.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Children's Hospital | Recruiting | Calgary | Alberta | T3B 6A8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40577780 | Derived | Booth J, Birnie KA, Chomistek K, Santana M, Stinson JN, Adebiyi BO, Brooks J, Guzman J, Hellweg R, Lim LS, Rumsey D, Feldman BM, Tagseth J, Wilson J, Schmeling H. A Virtual Self-Management Intervention for Adolescents With Juvenile Idiopathic Arthritis: Protocol for the VISTA-JIA Randomized Controlled Trial. JMIR Res Protoc. 2025 Jun 27;14:e69539. doi: 10.2196/69539. |
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| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| OTHER |
| University of British Columbia | OTHER |
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.
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The research team and all participants will be aware which arm they are enrolled in throughout the study.
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|
| No Intervention | Other | No intervention. Participant only receives standard of care. |
|
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. |
| 3 months |
| 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 | 3 months |
| 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 | 3 months |
| How Prepared the patient feels for Adult Care | Readiness for Adult Care in Rheumatology (RACER) questionnaire a reliable and validated instrument used to assess transition readiness in adolescents with JIA. | 3 months |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |