An Internet-based Self-management Program for Adolescents With Arthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Jennifer Stinson, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01572896
First received: April 3, 2012
Last updated: December 2, 2013
Last verified: December 2013

April 3, 2012
December 2, 2013
April 2012
March 2015   (final data collection date for primary outcome measure)
  • Pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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
  • Health-related Quality of Life (HRQL) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.
  • Pain [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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
  • Pain [ Time Frame: 3months ] [ Designated as safety issue: No ]
    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
  • Health-related Quality of Life (HRQL) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.
  • Pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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
  • Health-related Quality of Life (HRQL) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.
  • Health-related Quality of Life (HRQL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01572896 on ClinicalTrials.gov Archive Site
  • Emotional Symptoms [ Time Frame: Baseline, 3 months, 6 months and 12 months post-intervention ] [ Designated as safety issue: No ]
    Anxiety and depression will each be assessed using two, separate 8-item PROMIS (Patient Reported Outcomes Measurement Information System) scales.
  • Adherence [ Time Frame: Baseline, 3 months, 6 months and 12 months post-intervention ] [ Designated as safety issue: No ]
    Adherence to medical treatment will be assessed using the 34-item Child Adherence Report Questionnaire (CARQ)
  • Pain Coping [ Time Frame: Baseline, 3 months, 6 months and 12 months post-intervention ] [ Designated as safety issue: No ]
    Pain coping will be measured using the 18-item Pain Coping Questionnaire106, which is an internationally used measure of pain coping strategies in the pediatric population and has been validated in youth with arthritis.
  • Juvenile Idiopathic Arthritis (JIA) [ Time Frame: Baseline, 3 months, 6 months and 12 months post-intervention ] [ Designated as safety issue: No ]
    JIA-specific knowledge will be measured using 9-items from the Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS).
  • Self-Efficacy [ Time Frame: Baseline, 3 months, 6 months and 12 months post-intervention ] [ Designated as safety issue: No ]
    Self-efficacy will be measured using the Children's Arthritis Self-Efficacy (CASE) scale which is an 11-item measure.
Same as current
Not Provided
Not Provided
 
An Internet-based Self-management Program for Adolescents With Arthritis
An Internet-based Self-management Program for Adolescents With Arthritis: A Randomized Controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Arthritis, Juvenile Idiopathic
  • Behavioral: Taking Charge: Managing JIA Online
    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.
  • Behavioral: Standard Medical Care and JIA Resource Center
    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.
  • Experimental: Taking Charge Experimental Group
    Intervention: Behavioral: Taking Charge: Managing JIA Online
  • Active Comparator: Control Group
    Intervention: Behavioral: Standard Medical Care and JIA Resource Center
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
294
March 2015
March 2015   (final data collection date for primary outcome measure)

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.
Both
12 Years to 18 Years
No
Contact: Jennifer N Stinson, RN, PhD, CPNP 416-813-7654 ext 4514 jennifer.stinson@sickkids.ca
Canada
 
NCT01572896
1000028028
Yes
Jennifer Stinson, The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Jennifer N Stinson, RN, PhD, CPNP The Hospital for Sick Children
The Hospital for Sick Children
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP