Virtual Self-Management Program for JIA

NCT ID: NCT06184100

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-13

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Juvenile Idiopathic Arthritis

Keywords

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Virtual Education Clinical Trial JIA Self-management Program

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

The research team and all participants will be aware which arm they are enrolled in throughout the study.

Study Groups

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SMP Program with Standard Care

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

Group Type EXPERIMENTAL

Virtual Self-Management Program (SMP)

Intervention Type 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.

Standard Care Only

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

Group Type ACTIVE_COMPARATOR

No Intervention

Intervention Type OTHER

No intervention. Participant only receives standard of care.

Interventions

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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.

Intervention Type OTHER

No Intervention

No intervention. Participant only receives standard of care.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alberta Children's Hospital

Calgary, Alberta, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Heinrike Schmeling, MD, PhD

Role: CONTACT

Phone: 403-955-7698

Email: [email protected]

Jessica Booth, BSc

Role: CONTACT

Phone: 403-955-3194

Email: [email protected]

Facility Contacts

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Jessica Booth, BSc

Role: primary

References

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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.

Reference Type DERIVED
PMID: 40577780 (View on PubMed)

Other Identifiers

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VISTA-JIA

Identifier Type: -

Identifier Source: org_study_id