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

Arthritis, Juvenile Idiopathic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572896
• Other study ID #: 1000028028
• Status: Completed
• Phase: N/A
• First received: April 3, 2012
• Last updated: March 31, 2017
• Start date: April 2012
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: March 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Juvenile Idiopathic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary
Canada	Stollery Children's Hospital	Edmonton
Canada	IWK Health Centre	Halifax
Canada	Hamilton Health Sciences	Hamilton	Ontario
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	The Hospital for Sick Children	Toronto	Ontario
Canada	BC Children's Hospital	Vancouver
Canada	Winnepeg Children's Hospital	Winnepeg

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	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	12 months
Primary	Health-related Quality of Life (HRQL)	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.	Baseline
Primary	Pain	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	Baseline
Primary	Pain	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	3months
Primary	Health-related Quality of Life (HRQL)	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 months
Primary	Pain	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	6 months
Primary	Health-related Quality of Life (HRQL)	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 months
Primary	Health-related Quality of Life (HRQL)	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.	12 months
Secondary	Emotional Symptoms	Anxiety and depression will each be assessed using two, separate 8-item PROMIS (Patient Reported Outcomes Measurement Information System) scales.	Baseline, 3 months, 6 months and 12 months post-intervention
Secondary	Adherence	Adherence to medical treatment will be assessed using the 34-item Child Adherence Report Questionnaire (CARQ)	Baseline, 3 months, 6 months and 12 months post-intervention
Secondary	Pain Coping	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.	Baseline, 3 months, 6 months and 12 months post-intervention
Secondary	Juvenile Idiopathic Arthritis (JIA)	JIA-specific knowledge will be measured using 9-items from the Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS).	Baseline, 3 months, 6 months and 12 months post-intervention
Secondary	Self-Efficacy	Self-efficacy will be measured using the Children's Arthritis Self-Efficacy (CASE) scale which is an 11-item measure.	Baseline, 3 months, 6 months and 12 months post-intervention