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

Juvenile Idiopathic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011179
• Other study ID #: 1000010809
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: June 2009

Study information

• Verified date: March 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

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.
• Self-Management
Adolescents' "own best efforts" at managing their JIA

Locations

Country	Name	City	State
Canada	IWK Health Center	Halifax	Nova Scotia
Canada	Montreal Children's Hospital	Montreal	Quebec
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	BC Children's Hospital	Vancouver	British Columbia

Sponsors (6)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Canadian Arthritis Patient Alliance, Dalhousie University, IWK Health Centre, Provincial Health Services Authority, The Arthritis Society, Canada

Country where clinical trial is conducted

Canada, 

References & 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 ran — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Medical Issues Sub-Scale From Medical Issues, Exercise, Pain, and Social Support Questionnaire (MEPS)	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
Secondary	Pain Coping (Pain Coping Questionnaire)		Baseline (prior to randomization) and 3 months after intervention
Secondary	Children's Arthritis Self-Efficacy Scale (CASE)	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
Secondary	Child Adherence Report Questionnaire (CARQ)	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
Secondary	Perceived Stress Questionnaire (PSQ)	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