Virtual Self-Management Program for JIA

Официальное название

Feasibility and Acceptability of a Virtual Self-management Program - A Pilot Randomized Controlled Trial for Adolescents With Juvenile Idiopathic Arthritis

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Virtual Self-Management Program (SMP)
  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.
• Другое No Intervention
  No intervention. Participant only receives standard of care.

Первичные конечные точки

• Program Adherence Rates (feasability) [Срок оценки: 3 months]
• Satisfaction of Program [Срок оценки: 3 months]
• Intervention fidelity [Срок оценки: 3 months]

Вторичные конечные точки (5)

• Understanding of JIA [Срок оценки: 3 months]
• Understanding of Arthritis Self Efficacy [Срок оценки: 3 months]
• Quality of Life for Teens [Срок оценки: 3 months]
• Physical Pain Level [Срок оценки: 3 months]
• How Prepared the patient feels for Adult Care [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Канада · 1 центр

• Alberta Children's Hospital — Calgary

Публикации

• 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. PMID 40577780

Идентификаторы

NCT: NCT06184100 · VISTA-JIA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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