Juvenile Idiopathic ArthritisNCT01011179
Internet Self-Management Program With Telephone Support for Adolescents With Arthritis
A study testing Teens Taking Charge and Self-Management in people with Juvenile Idiopathic Arthritis, run by The Hospital for Sick Children at 4 sites in Canada.
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). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- Teens Taking Charge and Self-Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 4 sitesCanada
- Study dates
- Nov 2008to Jun 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- adolescents 12 to 18 years
- diagnosed with JIA,
- able to speak and read English or French
- able to complete baseline online outcome measures.
Who cannot join
- cognitive impairment
- major co-morbid illnesses (medical or psychiatric) which may impact their ability to understand and use the web-based program.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
IWK Health Center
Halifax, Nova Scotia
Montreal Children's Hospital
Montreal, Quebec
The Hospital for Sick Children
Toronto, Ontario
BC Children's Hospital
Vancouver, British Columbia
About this study
Official title: 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).
Read the 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
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- Teens Taking Charge, Self-Management
- Keywords
- Teens Taking Charge, Managing Arthritis Online, juvenile idiopathic arthritis, internet, self-management
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teens Taking ChargeBehavioural
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-ManagementBehavioural
Adolescents' "own best efforts" at managing their JIA
| Study group | Role | What they receive |
|---|---|---|
| Internet-based JIA Self-Management Program | Experimental | Not described Receives: Behavioral: Teens Taking Charge |
| Attention Control Group | Active comparator | Not described Receives: Behavioral: Self-Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (prior to randomization) and 3 months after intervention
Secondary outcomes (5)
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.
Measured: 3 months after intervention
Pain Coping (Pain Coping Questionnaire)
Measured: Baseline (prior to randomization) and 3 months after intervention
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.
Measured: 3 months after intervention
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.
Measured: 3 months after intervention
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.
Measured: 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startNov 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Arthritis Patient Alliance, Provincial Health Services Authority British Columbia, Dalhousie University, IWK Health Centre, The Arthritis Society, Canada
- Responsible party
- Principal investigator, Jennifer Stinson, The Hospital for Sick Children
- Investigators
- Patrick J McGrath, MD, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011179
- Sponsor's protocol ID
- 1000010809
- Status last verified
- Mar 2021
- First submitted
- 28 Sep 2009
- Last updated
- 29 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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 randomized controlled trial. J Rheumatol. 2010 Sep;37(9):1944-52. doi: 10.3899/jrheum.091327. Epub 2010 Jul 1.
PubMed 20595280
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Internet-based Self-management Program With Telephone Support for Adolescents With Arthritis: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01011179
- Acronym / sponsor ID
- 1000010809
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- Teens Taking Charge, Managing Arthritis Online, juvenile idiopathic arthritis, internet, self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Arthritis Patient Alliance, Provincial Health Services Authority British Columbia, Dalhousie University, IWK Health Centre, The Arthritis Society, Canada
- Study start
- Nov 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Posted 7 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based JIA Self-Management Program | Experimental | Behavioral: Teens Taking Charge |
| Attention Control Group | Active comparator | Behavioral: Self-Management |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- adolescents 12 to 18 years
- diagnosed with JIA,
- able to speak and read English or French
- able to complete baseline online outcome measures.
Key exclusion criteria (2 listed)
- cognitive impairment
- major co-morbid illnesses (medical or psychiatric) which may impact their ability to understand and use the web-based program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teens Taking ChargeThe 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. | Behavioural | Internet-based JIA Self-Management Program |
| Self-ManagementAdolescents' "own best efforts" at managing their JIA | Behavioural | Attention Control Group |
Primary outcome
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.
5 secondary outcomes
Medical Issues Sub-Scale From Medical Issues, Exercise, Pain, and Social Support Questionnaire (MEPS)
Time frame: 3 months after intervention
Pain Coping (Pain Coping Questionnaire)
Time frame: Baseline (prior to randomization) and 3 months after intervention
Children's Arthritis Self-Efficacy Scale (CASE)
Time frame: 3 months after intervention
Child Adherence Report Questionnaire (CARQ)
Time frame: 3 months after intervention
Perceived Stress Questionnaire (PSQ)
Time frame: 3 months after intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20595280Stinson 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 randomized controlled trial. J Rheumatol. 2010 Sep;37(9):1944-52. doi: 10.3899/jrheum.091327. Epub 2010 Jul 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick J McGrath, MD principal investigator
IWK Health Centre
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teens Taking Charge and Self-Management in people with Juvenile Idiopathic Arthritis, run by The Hospital for Sick Children at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Juvenile Arthritis Quality of Life Questionnaire (JAQQ) (time frame: Baseline (prior to randomization) and 3 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01011179, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.