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

March 31, 2017 updated by: Jennifer Stinson, The Hospital for Sick Children

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
333

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Calgary, Canada
        • Alberta Children's Hospital
      • Edmonton, Canada
        • Stollery Children'S Hospital
      • Halifax, Canada
        • IWK Health Centre
      • Montreal, Canada
        • Montreal Children's Hospital
      • Ottawa, Canada
        • Children'S Hospital Of Eastern Ontario
      • Saskatoon, Canada
        • Royal University
      • St. Johns, Canada
        • Janeway Children's Health and Rehabilitation Centre
      • Vancouver, Canada
        • BC Children's Hospital
      • Winnepeg, Canada
        • Winnepeg Children's Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • Hamilton Health Sciences
      • Toronto, Ontario, Canada, M5V1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 months
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.
Baseline
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
Baseline
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
3months
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 months
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
6 months
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.
3 months
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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months, 6 months and 12 months post-intervention
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)
Baseline, 3 months, 6 months and 12 months post-intervention
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.
Baseline, 3 months, 6 months and 12 months post-intervention
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).
Baseline, 3 months, 6 months and 12 months post-intervention
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.
Baseline, 3 months, 6 months and 12 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer N Stinson, RN, PhD, CPNP, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1000028028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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