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

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ClinicalTrials.gov Identifier: NCT01572896
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Arthritis, Juvenile Idiopathic Behavioral: Taking Charge: Managing JIA Online Behavioral: Standard Medical Care and JIA Resource Center

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 333 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: An Internet-based Self-management Program for Adolescents With Arthritis: A Randomized Controlled Trial
Study Start Date : April 2012
Primary Completion Date : March 2016
Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Taking Charge Experimental Group 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.
Active Comparator: Control Group 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.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572896


Locations
Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8S 4K1
The Hospital for Sick Children
Toronto, Ontario, Canada, 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
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Jennifer N Stinson, RN, PhD, CPNP The Hospital for Sick Children
More Information

Responsible Party: Jennifer Stinson, Clinician Scientist, Clinical Nurse Specialist/NP, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01572896     History of Changes
Other Study ID Numbers: 1000028028
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017

Keywords provided by Jennifer Stinson, The Hospital for Sick Children:
adoloescent
internet self-management
managing JIA

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases