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
  Purpose

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 Intervention
Arthritis, Juvenile Idiopathic
Behavioral: Taking Charge: Managing JIA Online
Behavioral: Standard Medical Care and JIA Resource Center

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: An Internet-based Self-management Program for Adolescents With Arthritis: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 294
Study Start Date: April 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572896

Contacts
Contact: Jennifer N Stinson, RN, PhD, CPNP 416-813-7654 ext 4514 jennifer.stinson@sickkids.ca

Locations
Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Tania Cellucci, MD         
Principal Investigator: Tania Cellucci, MD         
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5V1X8
Principal Investigator: Jennifer N Stinson, RN, PhD, CPNP         
Sub-Investigator: Brian Feldman, MD         
Canada
Alberta Children's Hospital Recruiting
Calgary, Canada
Principal Investigator: Nicole Johnson, MD         
Stollery Children's Hospital Recruiting
Edmonton, Canada
Principal Investigator: Janet Ellisworth, MD         
IWK Health Centre Recruiting
Halifax, Canada
Principal Investigator: Patrick McGrath, PhD         
Montreal Children's Hospital Recruiting
Montreal, Canada
Principal Investigator: Sarah Campillo, MD         
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Canada
Principal Investigator: Ciaran Duffy, MD         
Royal University Recruiting
Saskatoon, Canada
Principal Investigator: Alan Rosenberg, MD         
Janeway Children's Health and Rehabilitation Centre Recruiting
St. Johns, Canada
Principal Investigator: Paul Dancey, MD         
BC Children's Hospital Recruiting
Vancouver, Canada
Principal Investigator: Lori Tucker, MD         
Winnepeg Children's Hospital Recruiting
Winnepeg, Canada
Principal Investigator: Kiem Oen, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Jennifer N Stinson, RN, PhD, CPNP The Hospital for Sick Children
  More Information

No publications provided

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
Study First Received: April 3, 2012
Last Updated: December 2, 2013
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on July 29, 2014