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Completed

NCT Number: NCT01572896

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

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.

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Key information

Conditions

Arthritis, Juvenile Idiopathic Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton Health Sciences, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Taking Charge: Managing JIA Online

Behavioral

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.

Standard Medical Care and JIA Resource Center

Behavioral

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.

Primary outcomes

  1. Pain

    Time frame: 12 months

    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

  2. Health-related Quality of Life (HRQL)

    Time frame: Baseline

    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. Pain

    Time frame: Baseline

    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

  4. Pain

    Time frame: 3months

    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

  5. Health-related Quality of Life (HRQL)

    Time frame: 6 months

    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. Pain

    Time frame: 6 months

    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

  7. Health-related Quality of Life (HRQL)

    Time frame: 3 months

    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.

  8. Health-related Quality of Life (HRQL)

    Time frame: 12 months

    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.

Secondary outcomes

  1. Emotional Symptoms

    Time frame: Baseline, 3 months, 6 months and 12 months post-intervention

    Anxiety and depression will each be assessed using two, separate 8-item PROMIS (Patient Reported Outcomes Measurement Information System) scales.

  2. Adherence

    Time frame: Baseline, 3 months, 6 months and 12 months post-intervention

    Adherence to medical treatment will be assessed using the 34-item Child Adherence Report Questionnaire (CARQ)

  3. Pain Coping

    Time frame: Baseline, 3 months, 6 months and 12 months post-intervention

    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.

  4. Juvenile Idiopathic Arthritis (JIA)

    Time frame: Baseline, 3 months, 6 months and 12 months post-intervention

    JIA-specific knowledge will be measured using 9-items from the Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS).

  5. Self-Efficacy

    Time frame: Baseline, 3 months, 6 months and 12 months post-intervention

    Self-efficacy will be measured using the Children's Arthritis Self-Efficacy (CASE) scale which is an 11-item measure.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

An Internet-based Self-management Program for Adolescents With Arthritis: A Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Apr 6, 2012
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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