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Completed

NCT Number: NCT01011179

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

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).

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Key information

Conditions

Juvenile Idiopathic Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BC Children's Hospital, Vancouver, British Columbia, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Teens Taking Charge

Behavioral

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.

Self-Management

Behavioral

Adolescents' "own best efforts" at managing their JIA

Primary outcomes

  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 outcomes

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

    Time frame: 3 months after intervention

    Measure looks at disease specific knowledge. Subscale used: Medical Issues Subscale scores range from 0 (min) - 10 (max) with higher scores indicating greater knowledge.

  2. Pain Coping (Pain Coping Questionnaire)

    Time frame: Baseline (prior to randomization) and 3 months after intervention

  3. Children's Arthritis Self-Efficacy Scale (CASE)

    Time frame: 3 months after intervention

    Measure looks at Self-efficacy. Subscales: Activity, Emotion, Family. Subscale scores range 0 - 10 with higher scores indicating greater self-efficacy.

  4. Child Adherence Report Questionnaire (CARQ)

    Time frame: 3 months after intervention

    Measure examines adherence to treatment. Subscales: Treatment Adherence to: Medication, Exercise, Splints. Subscale scores rage 0 - 10 with higher scores indicate better overall child ability in relation to following treatment recommendations.

  5. Perceived Stress Questionnaire (PSQ)

    Time frame: 3 months after intervention

    Measure examines stress. Total score calculated was an average of all items with a range from 1-4 with higher scores indicating greater stress.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Canadian Arthritis Patient Alliance
  • Dalhousie University
  • IWK Health Centre
  • Provincial Health Services Authority British Columbia
  • The Arthritis Society, Canada

Registry information

Official study title

An Internet-based Self-management Program With Telephone Support for Adolescents With Arthritis: A Pilot Randomized Controlled Trial

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 11, 2009
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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