Clinical trial NCT01011179: Internet Self-Management Program With Telephone Support for Adolescents With Arthritis
Official title: An Internet-based Self-management Program With Telephone Support for Adolescents With Arthritis: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Keywords: Teens Taking Charge
Managing Arthritis Online
juvenile idiopathic arthritis
internet
self-management
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Arthritis Patient Alliance
name: Provincial Health Services Authority
name: Dalhousie University
name: IWK Health Centre
name: The Arthritis Society, Canada
First posted: 2009-11-11
Enrollment: 46
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: This study will evaluate the feasibility of "Teens Taking Charge: Managing Arthritis On-line" intervention that will help adolescents with arthritis to better manage their disease and improve their health-related quality of life (HRQL).

Detailed description: This feasibility study will (1) assess adolescents' willingness to be randomized; (2) pilot the intervention, attention control strategies (e.g., adolescents' 'own best efforts' at managing arthritis), and outcome measures; (3) determine adolescents' perceptions regarding acceptability of the web-based intervention; and (4) obtain estimates of treatment effects in primary (HRQL) and secondary (knowledge, coping, self-efficacy, stress, treatment adherence, pain) outcome measures to inform the calculation of appropriate sample size for the future RCT.

We hypothesize that adolescents with JIA in the web-based intervention will demonstrate: (a) improved HRQL; (b) increased disease-specific knowledge; (c) improved coping, self-efficacy, and adherence to prescribed management; and (d) decreased pain and stress compared to adolescents in the attention control group

Eligibility criteria: Inclusion Criteria:

* adolescents 12 to 18 years
* diagnosed with JIA,
* able to speak and read English or French
* able to complete baseline online outcome measures.

Exclusion Criteria:

* cognitive impairment
* major co-morbid illnesses (medical or psychiatric) which may impact their ability to understand and use the web-based program.

Primary outcomes:
measure: Juvenile Arthritis Quality of Life Questionnaire (JAQQ)
timeFrame: Baseline (prior to randomization) and 3 months after intervention
Secondary outcomes:
measure: Medical Issues Sub-Scale From Medical Issues, Exercise, Pain, and Social Support Questionnaire (MEPS)
timeFrame: 3 months after intervention
measure: Pain Coping (Pain Coping Questionnaire)
timeFrame: Baseline (prior to randomization) and 3 months after intervention
measure: Children's Arthritis Self-Efficacy Scale (CASE)
timeFrame: 3 months after intervention
measure: Child Adherence Report Questionnaire (CARQ)
timeFrame: 3 months after intervention
measure: Perceived Stress Questionnaire (PSQ)
timeFrame: 3 months after intervention
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: IWK Health Center
state: Nova Scotia
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
Study officials:
affiliation: IWK Health Centre
name: Patrick J McGrath, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stinson JN, McGrath PJ, Hodnett ED, Feldman BM, Duffy CM, Huber AM, Tucker LB, Hetherington CR, Tse SM, Spiegel LR, Campillo S, Gill NK, White ME. An internet-based self-management program with telephone support for adolescents with arthritis: a pilot randomized controlled trial. J Rheumatol. 2010 Sep;37(9):1944-52. doi: 10.3899/jrheum.091327. Epub 2010 Jul 1.