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

• ClinicalTrials.gov Identifier: NCT01572896
• Recruitment Status: Completed
• First Posted: April 6, 2012
• Last Update Posted: April 4, 2017
• Sponsor: The Hospital for Sick Children
• Information provided by (Responsible Party): Jennifer Stinson, The Hospital for Sick Children

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	Phase
Arthritis, Juvenile Idiopathic	Behavioral: Taking Charge: Managing JIA Online; Behavioral: Standard Medical Care and JIA Resource Center	Not Applicable

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
• Actual Primary Completion Date: March 2016
• Actual Study Completion Date: March 2017

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

• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Stinson JN, Lalloo C, Hundert AS, Campillo S, Cellucci T, Dancey P, Duffy C, Ellsworth J, Feldman BM, Huber AM, Johnson N, Jong G, Oen K, Rosenberg AM, Shiff NJ, Spiegel L, Tse SML, Tucker L, Victor JC. Teens Taking Charge: A Randomized Controlled Trial of a Web-Based Self-Management Program With Telephone Support for Adolescents With Juvenile Idiopathic Arthritis. J Med Internet Res. 2020 Jul 29;22(7):e16234. doi: 10.2196/16234.

• Responsible Party: Jennifer Stinson, Clinician Scientist, Clinical Nurse Specialist/NP, The Hospital for Sick Children
• ClinicalTrials.gov Identifier: NCT01572896
• Other Study ID Numbers: 1000028028
• First Posted: April 6, 2012
• 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