Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06184100
Status:
RECRUITING
Last Update Posted:
2023-12-28
First Post:
2023-11-10
Brief Title:
Virtual Self-Management Program for JIA
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
A Pilot Randomized Controlled Trial Feasibility and Acceptability of a Virtual Adolescent Self-management Program for Juvenile Idiopathic Arthritis
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 11 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 Childrens Arthritis Self-Efficacy Scale CASES C Pediatric Quality of Life Inventory 30 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
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 Childrens Arthritis Self-Efficacy Scale CASES C Pediatric Quality of Life Inventory 30 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None