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

March 26, 2021 updated by: Jennifer Stinson, The Hospital for Sick Children

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • BC Children's Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • IWK Health Center
    • Ontario
      • Toronto, Ontario, Canada
        • The Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canada
        • Montreal Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (prior to randomization) and 3 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after intervention
Pain Coping (Pain Coping Questionnaire)
Time Frame: Baseline (prior to randomization) and 3 months after intervention
Baseline (prior to randomization) and 3 months after intervention
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.
3 months after intervention
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.
3 months after intervention
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.
3 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

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

Investigators

  • Principal Investigator: Patrick J McGrath, MD, IWK Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

September 28, 2009

First Submitted That Met QC Criteria

November 9, 2009

First Posted (Estimate)

November 11, 2009

Study Record Updates

Last Update Posted (Actual)

March 29, 2021

Last Update Submitted That Met QC Criteria

March 26, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000010809

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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