Clinical trial NCT01572896: An Internet-based Self-management Program for Adolescents With Arthritis
Official title: An Internet-based Self-management Program for Adolescents With Arthritis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis, Juvenile Idiopathic
Keywords: adoloescent
internet self-management
managing JIA
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2012-04-06
Enrollment: 333
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: In summary, no rigorous Internet self-management intervention has been undertaken to improve HRQL, symptoms, treatment adherence, knowledge, and self-efficacy in youth with JIA. The proposed "Managing JIA Online" Trial will rigorously examine the effects of this Internet intervention on HRQL and other health outcomes thereby filling a significant gap in our knowledge related to promotion of self-management care for adolescents with JIA.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain
timeFrame: 12 months
measure: Health-related Quality of Life (HRQL)
timeFrame: Baseline
measure: Pain
timeFrame: Baseline
measure: Pain
timeFrame: 3months
measure: Health-related Quality of Life (HRQL)
timeFrame: 6 months
measure: Pain
timeFrame: 6 months
measure: Health-related Quality of Life (HRQL)
timeFrame: 3 months
measure: Health-related Quality of Life (HRQL)
timeFrame: 12 months
Secondary outcomes:
measure: Emotional Symptoms
timeFrame: Baseline, 3 months, 6 months and 12 months post-intervention
measure: Adherence
timeFrame: Baseline, 3 months, 6 months and 12 months post-intervention
measure: Pain Coping
timeFrame: Baseline, 3 months, 6 months and 12 months post-intervention
measure: Juvenile Idiopathic Arthritis (JIA)
timeFrame: Baseline, 3 months, 6 months and 12 months post-intervention
measure: Self-Efficacy
timeFrame: Baseline, 3 months, 6 months and 12 months post-intervention
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Calgary
country: Canada
facility: Alberta Children's Hospital
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
city: Halifax
country: Canada
facility: IWK Health Centre
city: Montreal
country: Canada
facility: Montreal Children's Hospital
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
city: Saskatoon
country: Canada
facility: Royal University
city: St. Johns
country: Canada
facility: Janeway Children's Health and Rehabilitation Centre
city: Vancouver
country: Canada
facility: BC Children's Hospital
city: Winnepeg
country: Canada
facility: Winnepeg Children's Hospital
Study officials:
affiliation: The Hospital for Sick Children
name: Jennifer N Stinson, RN, PhD, CPNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.