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

Primary Purpose

Arthritis, Juvenile Idiopathic

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Taking Charge: Managing JIA Online
Standard Medical Care and JIA Resource Center
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Juvenile Idiopathic focused on measuring adoloescent, internet self-management, managing JIA

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hamilton Health Sciences
  • The Hospital for Sick Children
  • Alberta Children's Hospital
  • Stollery Children's Hospital
  • IWK Health Centre
  • Montreal Children's Hospital
  • Children's Hospital of Eastern Ontario
  • Royal University
  • Janeway Children's Health and Rehabilitation Centre
  • BC Children's Hospital
  • Winnepeg Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Taking Charge Experimental Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

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
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.
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
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
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.
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
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.
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.

Secondary Outcome Measures

Emotional Symptoms
Anxiety and depression will each be assessed using two, separate 8-item PROMIS (Patient Reported Outcomes Measurement Information System) scales.
Adherence
Adherence to medical treatment will be assessed using the 34-item Child Adherence Report Questionnaire (CARQ)
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.
Juvenile Idiopathic Arthritis (JIA)
JIA-specific knowledge will be measured using 9-items from the Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS).
Self-Efficacy
Self-efficacy will be measured using the Children's Arthritis Self-Efficacy (CASE) scale which is an 11-item measure.

Full Information

First Posted
April 3, 2012
Last Updated
March 31, 2017
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT01572896
Brief Title
An Internet-based Self-management Program for Adolescents With Arthritis
Official Title
An Internet-based Self-management Program for Adolescents With Arthritis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Juvenile Idiopathic
Keywords
adoloescent, internet self-management, managing JIA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
333 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Taking Charge Experimental Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Taking Charge: Managing JIA Online
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Medical Care and JIA Resource Center
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain
Description
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
Time Frame
12 months
Title
Health-related Quality of Life (HRQL)
Description
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.
Time Frame
Baseline
Title
Pain
Description
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
Time Frame
Baseline
Title
Pain
Description
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
Time Frame
3months
Title
Health-related Quality of Life (HRQL)
Description
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.
Time Frame
6 months
Title
Pain
Description
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
Time Frame
6 months
Title
Health-related Quality of Life (HRQL)
Description
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.
Time Frame
3 months
Title
Health-related Quality of Life (HRQL)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Emotional Symptoms
Description
Anxiety and depression will each be assessed using two, separate 8-item PROMIS (Patient Reported Outcomes Measurement Information System) scales.
Time Frame
Baseline, 3 months, 6 months and 12 months post-intervention
Title
Adherence
Description
Adherence to medical treatment will be assessed using the 34-item Child Adherence Report Questionnaire (CARQ)
Time Frame
Baseline, 3 months, 6 months and 12 months post-intervention
Title
Pain Coping
Description
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.
Time Frame
Baseline, 3 months, 6 months and 12 months post-intervention
Title
Juvenile Idiopathic Arthritis (JIA)
Description
JIA-specific knowledge will be measured using 9-items from the Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS).
Time Frame
Baseline, 3 months, 6 months and 12 months post-intervention
Title
Self-Efficacy
Description
Self-efficacy will be measured using the Children's Arthritis Self-Efficacy (CASE) scale which is an 11-item measure.
Time Frame
Baseline, 3 months, 6 months and 12 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer N Stinson, RN, PhD, CPNP
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5V1X8
Country
Canada
Facility Name
Alberta Children's Hospital
City
Calgary
Country
Canada
Facility Name
Stollery Children's Hospital
City
Edmonton
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
Country
Canada
Facility Name
Montreal Children's Hospital
City
Montreal
Country
Canada
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
Country
Canada
Facility Name
Royal University
City
Saskatoon
Country
Canada
Facility Name
Janeway Children's Health and Rehabilitation Centre
City
St. Johns
Country
Canada
Facility Name
BC Children's Hospital
City
Vancouver
Country
Canada
Facility Name
Winnepeg Children's Hospital
City
Winnepeg
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
32723728
Citation
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.
Results Reference
derived

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

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