An Internet-based Self-management Program for Adolescents With Arthritis
1 other identifier
interventional
333
1 country
11
Brief Summary
The purpose of this study is to demonstrate the effectiveness of the "Taking Charge: Managing JIA Online" Internet intervention, when compared with an attention (static education only websites) control group in improving pain and HRQL as well as other health outcomes (anxiety, depression, treatment adherence, pain coping, knowledge, and self-efficacy) in adolescents with JIA. The proposed study will enroll and randomize 294 adolescents with JIA attending 10 pediatric rheumatology hospital clinics in the Canada to either the experimental or control groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2012
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 3, 2012
CompletedFirst Posted
Study publicly available on registry
April 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedApril 4, 2017
March 1, 2017
3.9 years
April 3, 2012
March 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Pain
Pain will be measured using the Recalled Pain Inventory - Short Form.91 The RPI measures current as well as least, average and worst pain intensity, pain unpleasantness, and pain interference ratings over the past week with items rated on a 11-point numerical rating scale (NRS) (e.g., 0 = 'no pain' to 10 = 'severe pain') and painful body locations. This 11-item measure has evidence of construct validity
12 months
Health-related Quality of Life (HRQL)
HRQL will be measured using the teen and parent PedsQL Rheumatology Modules.13 Both of the PedsQL rheumatology modules contain a 22-item self-report and parent scale with five subscales: pain and hurt, daily activities, treatment, worry, and communication.
Baseline
Pain
Pain will be measured using the Recalled Pain Inventory - Short Form.91 The RPI measures current as well as least, average and worst pain intensity, pain unpleasantness, and pain interference ratings over the past week with items rated on a 11-point numerical rating scale (NRS) (e.g., 0 = 'no pain' to 10 = 'severe pain') and painful body locations. This 11-item measure has evidence of construct validity
Baseline
Pain
Pain will be measured using the Recalled Pain Inventory - Short Form.91 The RPI measures current as well as least, average and worst pain intensity, pain unpleasantness, and pain interference ratings over the past week with items rated on a 11-point numerical rating scale (NRS) (e.g., 0 = 'no pain' to 10 = 'severe pain') and painful body locations. This 11-item measure has evidence of construct validity
3months
Health-related Quality of Life (HRQL)
HRQL will be measured using the teen and parent PedsQL Rheumatology Modules.13 Both of the PedsQL rheumatology modules contain a 22-item self-report and parent scale with five subscales: pain and hurt, daily activities, treatment, worry, and communication.
6 months
Pain
Pain will be measured using the Recalled Pain Inventory - Short Form.91 The RPI measures current as well as least, average and worst pain intensity, pain unpleasantness, and pain interference ratings over the past week with items rated on a 11-point numerical rating scale (NRS) (e.g., 0 = 'no pain' to 10 = 'severe pain') and painful body locations. This 11-item measure has evidence of construct validity
6 months
Health-related Quality of Life (HRQL)
HRQL will be measured using the teen and parent PedsQL Rheumatology Modules.13 Both of the PedsQL rheumatology modules contain a 22-item self-report and parent scale with five subscales: pain and hurt, daily activities, treatment, worry, and communication.
3 months
Health-related Quality of Life (HRQL)
HRQL will be measured using the teen and parent PedsQL Rheumatology Modules.13 Both of the PedsQL rheumatology modules contain a 22-item self-report and parent scale with five subscales: pain and hurt, daily activities, treatment, worry, and communication.
12 months
Secondary Outcomes (5)
Emotional Symptoms
Baseline, 3 months, 6 months and 12 months post-intervention
Adherence
Baseline, 3 months, 6 months and 12 months post-intervention
Pain Coping
Baseline, 3 months, 6 months and 12 months post-intervention
Juvenile Idiopathic Arthritis (JIA)
Baseline, 3 months, 6 months and 12 months post-intervention
Self-Efficacy
Baseline, 3 months, 6 months and 12 months post-intervention
Study Arms (2)
Taking Charge Experimental Group
EXPERIMENTALControl Group
ACTIVE COMPARATORInterventions
In addition to standard medical care, adolescents in the experimental group will receive the "Taking Charge: Managing JIA Online" Internet self-management program. The intervention is a 12-module interactive multi-component treatment protocol - that consists of JIA-specific education, self-management strategies, and social support - that is available in English and French.
The control group is designed to control for the potential effects on outcomes of time, attention and computer use during the intervention and through the 9-month follow-up period. In addition to standard medical care, adolescents in the attention control group will be provided with access to a self-guided patient education study website, which will have two components: basic patient educational materials about JIA ("JIA Resource Centre") and online assessments.
Eligibility Criteria
You may qualify if:
- Age ≥12 and ≤ 18 years.
- Diagnosed with JIA (using International League of Associations for Rheumatology classification criteria)83 by their rheumatologist.
- Adolescents and parent/ primary caregiver are able to speak and read either English or French.
- Participants are willing and able to complete online measures. There will be no restrictions on medication use for this study.
You may not qualify if:
- Cognitive impairments (as assessed by reviewing medical chart and consultation with the patient's rheumatologist)
- Major co-morbid illnesses which may mitigate HRQL assessment
- Excluded medical illnesses: inflammatory bowel disease, fibromyalgia, cancer, genetic disorders, diabetes
- Excluded psychiatric conditions: post-traumatic stress disorder, panic disorder, bipolar disorder, psychosis, depression and major mood disorders. Adolescents currently on medications for major depression, bipolar disorder or psychosis would also be excluded.
- Adolescents that are currently participating in other CBT interventions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Hamilton Health Sciences
Hamilton, Ontario, L8S 4K1, Canada
The Hospital for Sick Children
Toronto, Ontario, M5V1X8, Canada
Alberta Children's Hospital
Calgary, Canada
Stollery Children's Hospital
Edmonton, Canada
IWK Health Centre
Halifax, Canada
Montreal Children's Hospital
Montreal, Canada
Children's Hospital of Eastern Ontario
Ottawa, Canada
Royal University
Saskatoon, Canada
Janeway Children's Health and Rehabilitation Centre
St. Johns, Canada
BC Children's Hospital
Vancouver, Canada
Winnepeg Children's Hospital
Winnepeg, Canada
Related Publications (1)
Stinson JN, Lalloo C, Hundert AS, Campillo S, Cellucci T, Dancey P, Duffy C, Ellsworth J, Feldman BM, Huber AM, Johnson N, Jong G, Oen K, Rosenberg AM, Shiff NJ, Spiegel L, Tse SML, Tucker L, Victor JC. Teens Taking Charge: A Randomized Controlled Trial of a Web-Based Self-Management Program With Telephone Support for Adolescents With Juvenile Idiopathic Arthritis. J Med Internet Res. 2020 Jul 29;22(7):e16234. doi: 10.2196/16234.
PMID: 32723728DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer N Stinson, RN, PhD, CPNP
The Hospital for Sick Children
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinician Scientist, Clinical Nurse Specialist/NP
Study Record Dates
First Submitted
April 3, 2012
First Posted
April 6, 2012
Study Start
April 1, 2012
Primary Completion
March 1, 2016
Study Completion
March 1, 2017
Last Updated
April 4, 2017
Record last verified: 2017-03