NCT01011179

Brief Summary

This study will evaluate the feasibility of "Teens Taking Charge: Managing Arthritis On-line" intervention that will help adolescents with arthritis to better manage their disease and improve their health-related quality of life (HRQL).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

March 7, 2014

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

September 28, 2009

Results QC Date

December 4, 2013

Last Update Submit

March 26, 2021

Conditions

Keywords

Teens Taking ChargeManaging Arthritis Onlinejuvenile idiopathic arthritisinternetself-management

Outcome Measures

Primary Outcomes (1)

  • Juvenile Arthritis Quality of Life Questionnaire (JAQQ)

    The questionnaire is divided into 4 dimensions: gross motor function, fine motor function, psychosocial function, and general symptoms. A 7-point ordinal scale is used to rate responses to each item from 1 (none of the time) to 7 (all of the time), based on how often the item was a problem for the child over the past 2 weeks. Total score was composed of the 4 dimension scores (top 5 items of that dimension) divided by 4, with higher scores denoting poorer HRQOL.

    Baseline (prior to randomization) and 3 months after intervention

Secondary Outcomes (5)

  • Medical Issues Sub-Scale From Medical Issues, Exercise, Pain, and Social Support Questionnaire (MEPS)

    3 months after intervention

  • Pain Coping (Pain Coping Questionnaire)

    Baseline (prior to randomization) and 3 months after intervention

  • Children's Arthritis Self-Efficacy Scale (CASE)

    3 months after intervention

  • Child Adherence Report Questionnaire (CARQ)

    3 months after intervention

  • Perceived Stress Questionnaire (PSQ)

    3 months after intervention

Study Arms (2)

Internet-based JIA Self-Management Program

EXPERIMENTAL
Behavioral: Teens Taking Charge

Attention Control Group

ACTIVE COMPARATOR
Behavioral: Self-Management

Interventions

The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.

Internet-based JIA Self-Management Program
Self-ManagementBEHAVIORAL

Adolescents' "own best efforts" at managing their JIA

Attention Control Group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • adolescents 12 to 18 years
  • diagnosed with JIA,
  • able to speak and read English or French
  • able to complete baseline online outcome measures.

You may not qualify if:

  • cognitive impairment
  • major co-morbid illnesses (medical or psychiatric) which may impact their ability to understand and use the web-based program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

BC Children's Hospital

Vancouver, British Columbia, Canada

Location

IWK Health Center

Halifax, Nova Scotia, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, Canada

Location

Related Publications (1)

  • Stinson JN, McGrath PJ, Hodnett ED, Feldman BM, Duffy CM, Huber AM, Tucker LB, Hetherington CR, Tse SM, Spiegel LR, Campillo S, Gill NK, White ME. An internet-based self-management program with telephone support for adolescents with arthritis: a pilot randomized controlled trial. J Rheumatol. 2010 Sep;37(9):1944-52. doi: 10.3899/jrheum.091327. Epub 2010 Jul 1.

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Self-Management

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. Jennifer Stinson
Organization
The Hospital for Sick Children

Study Officials

  • Patrick J McGrath, MD

    IWK Health Centre

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientist

Study Record Dates

First Submitted

September 28, 2009

First Posted

November 11, 2009

Study Start

November 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

March 29, 2021

Results First Posted

March 7, 2014

Record last verified: 2021-03

Locations