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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01011179
First received: September 28, 2009
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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 Intervention
Juvenile Idiopathic Arthritis
Behavioral: Teens Taking Charge
Behavioral: Self-Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Juvenile Arthritis Quality of Life Questionnaire (JAQQ) [ Time Frame: Baseline (prior to randomization) and 3 months after intervention ] [ Designated as safety issue: No ]
    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:
  • Disease Specific Knowledge (Medical Issues, Exercise, Pain and Social Support Questionnaire; MEPS) [ Time Frame: Baseline (prior to randomization) and 3 months after intervention ] [ Designated as safety issue: No ]
  • Pain Coping (Pain Coping Questionnaire) [ Time Frame: Baseline (prior to randomization) and 3 months after intervention ] [ Designated as safety issue: No ]
  • Self-efficacy (Children's Arthritis Self-Efficacy Scale; CASE) [ Time Frame: Baseline (prior to randomization) and 3 months after intervention ] [ Designated as safety issue: No ]
  • Adherence to Treatment (Child Adherence Report Questionnaire; CARQ) [ Time Frame: Baseline (prior to randomization) and 3 months after intervention ] [ Designated as safety issue: No ]
  • Stress (Perceived Stress Questionnaire; PSQ) [ Time Frame: Baseline (prior to randomization) and 3 months after intervention ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: November 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Jennifer Stinson, Scientist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01011179     History of Changes
Other Study ID Numbers: 1000010809
Study First Received: September 28, 2009
Results First Received: December 4, 2013
Last Updated: January 22, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on September 22, 2014