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Internet Self-Management Program With Telephone Support for Adolescents With Arthritis

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ClinicalTrials.gov Identifier: NCT01011179
Recruitment Status : Completed
First Posted : November 11, 2009
Results First Posted : March 7, 2014
Last Update Posted : January 24, 2018
Sponsor:
Collaborators:
Canadian Arthritis Patient Alliance
Provincial Health Services Authority
Dalhousie University
IWK Health Centre
The Arthritis Society, Canada
Information provided by (Responsible Party):
Jennifer Stinson, The Hospital for Sick Children

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).

Condition or disease Intervention/treatment
Juvenile Idiopathic Arthritis Behavioral: Teens Taking Charge Behavioral: Self-Management

Detailed Description:

This feasibility study will (1) assess adolescents' willingness to be randomized; (2) pilot the intervention, attention control strategies (e.g., adolescents' 'own best efforts' at managing arthritis), and outcome measures; (3) determine adolescents' perceptions regarding acceptability of the web-based intervention; and (4) obtain estimates of treatment effects in primary (HRQL) and secondary (knowledge, coping, self-efficacy, stress, treatment adherence, pain) outcome measures to inform the calculation of appropriate sample size for the future RCT.

We hypothesize that adolescents with JIA in the web-based intervention will demonstrate: (a) improved HRQL; (b) increased disease-specific knowledge; (c) improved coping, self-efficacy, and adherence to prescribed management; and (d) decreased pain and stress compared to adolescents in the attention control group


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Internet-based Self-management Program With Telephone Support for Adolescents With Arthritis: A Pilot Randomized Controlled Trial
Study Start Date : November 2008
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Internet-based JIA Self-Management Program Behavioral: Teens Taking Charge
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.
Active Comparator: Attention Control Group Behavioral: Self-Management
Adolescents' "own best efforts" at managing their JIA



Primary Outcome Measures :
  1. Juvenile Arthritis Quality of Life Questionnaire (JAQQ) [ Time Frame: Baseline (prior to randomization) and 3 months after intervention ]
    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.


Secondary Outcome Measures :
  1. Disease Specific Knowledge (Medical Issues, Exercise, Pain and Social Support Questionnaire; MEPS) [ Time Frame: Baseline (prior to randomization) and 3 months after intervention ]
  2. Pain Coping (Pain Coping Questionnaire) [ Time Frame: Baseline (prior to randomization) and 3 months after intervention ]
  3. Self-efficacy (Children's Arthritis Self-Efficacy Scale; CASE) [ Time Frame: Baseline (prior to randomization) and 3 months after intervention ]
  4. Adherence to Treatment (Child Adherence Report Questionnaire; CARQ) [ Time Frame: Baseline (prior to randomization) and 3 months after intervention ]
  5. Stress (Perceived Stress Questionnaire; PSQ) [ Time Frame: Baseline (prior to randomization) and 3 months after intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01011179


Locations
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada
Canada, Nova Scotia
IWK Health Center
Halifax, Nova Scotia, Canada
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
Canada, Quebec
Montreal Children's Hospital
Montreal, Quebec, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Canadian Arthritis Patient Alliance
Provincial Health Services Authority
Dalhousie University
IWK Health Centre
The Arthritis Society, Canada
Investigators
Principal Investigator: Patrick J McGrath, MD IWK Health Centre

Publications:
Responsible Party: Jennifer Stinson, Scientist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01011179     History of Changes
Other Study ID Numbers: 1000010809
First Posted: November 11, 2009    Key Record Dates
Results First Posted: March 7, 2014
Last Update Posted: January 24, 2018
Last Verified: December 2017

Keywords provided by Jennifer Stinson, The Hospital for Sick Children:
Teens Taking Charge
Managing Arthritis Online
juvenile idiopathic arthritis
internet
self-management

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases