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

NCT ID: NCT01572896

Last Updated: 2017-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

333 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Arthritis, Juvenile Idiopathic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Taking Charge Experimental Group

Group Type EXPERIMENTAL

Taking Charge: Managing JIA Online

Intervention Type BEHAVIORAL

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.

Control Group

Group Type ACTIVE_COMPARATOR

Standard Medical Care and JIA Resource Center

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Stinson

Clinician Scientist, Clinical Nurse Specialist/NP

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer N Stinson, RN, PhD, CPNP

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Alberta Children's Hospital

Calgary, , Canada

Site Status

Stollery Children's Hospital

Edmonton, , Canada

Site Status

IWK Health Centre

Halifax, , Canada

Site Status

Montreal Children's Hospital

Montreal, , Canada

Site Status

Children's Hospital of Eastern Ontario

Ottawa, , Canada

Site Status

Royal University

Saskatoon, , Canada

Site Status

Janeway Children's Health and Rehabilitation Centre

St. Johns, , Canada

Site Status

BC Children's Hospital

Vancouver, , Canada

Site Status

Winnepeg Children's Hospital

Winnepeg, , Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 32723728 (View on PubMed)

Other Identifiers

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1000028028

Identifier Type: -

Identifier Source: org_study_id

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