Arthritis, Juvenile IdiopathicNCT01572896
An Internet-based Self-management Program for Adolescents With Arthritis
A study testing Taking Charge: Managing JIA Online and Standard Medical Care and JIA Resource Center in people with Arthritis, Juvenile Idiopathic, run by The Hospital for Sick Children at 11 sites in Canada.
Trial summary
The purpose of this study is to demonstrate the effectiveness of the "Taking Charge: Managing JIA Online" Internet intervention, when compared with an attention (static education only websites) control group in improving pain and HRQL as well as other health outcomes (anxiety, depression, treatment adherence, pain… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Arthritis, Juvenile Idiopathic
- What is being tested?
- Taking Charge: Managing JIA Online and Standard Medical Care and JIA Resource Center
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 11 sitesCanada
- Study dates
- Apr 2012to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age ≥12 and ≤ 18 years.
- Diagnosed with JIA (using International League of Associations for Rheumatology classification criteria)83 by their rheumatologist.
- Adolescents and parent/ primary caregiver are able to speak and read either English or French.
- Participants are willing and able to complete online measures. There will be no restrictions on medication use for this study.
Who cannot join
- Cognitive impairments (as assessed by reviewing medical chart and consultation with the patient's rheumatologist)
- Major co-morbid illnesses which may mitigate HRQL assessment
- Excluded medical illnesses: inflammatory bowel disease, fibromyalgia, cancer, genetic disorders, diabetes
- Excluded psychiatric conditions: post-traumatic stress disorder, panic disorder, bipolar disorder, psychosis, depression and major mood disorders. Adolescents currently on medications for major depression, bipolar disorder or psychosis would also be excluded.
- Adolescents that are currently participating in other CBT interventions.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Canada11 sites
Alberta Children's Hospital
Calgary
Stollery Children's Hospital
Edmonton
IWK Health Centre
Halifax
Hamilton Health Sciences
Hamilton, Ontario, L8S 4K1
Montreal Children's Hospital
Montreal
Children's Hospital of Eastern Ontario
Ottawa
Royal University
Saskatoon
Janeway Children's Health and Rehabilitation Centre
St. Johns
The Hospital for Sick Children
Toronto, Ontario, M5V1X8
BC Children's Hospital
Vancouver
Winnepeg Children's Hospital
Winnepeg
About this study
Official title: An Internet-based Self-management Program for Adolescents With Arthritis: A Randomized Controlled Trial
The purpose of this study is to demonstrate the effectiveness of the "Taking Charge: Managing JIA Online" Internet intervention, when compared with an attention (static education only websites) control group in improving pain and HRQL as well as other health outcomes (anxiety, depression, treatment adherence, pain coping, knowledge, and self-efficacy) in adolescents with JIA. The proposed study will enroll and randomize 294 adolescents with JIA attending 10 pediatric rheumatology hospital clinics in the Canada to either the experimental or control groups.
Read the detailed description
In summary, no rigorous Internet self-management intervention has been undertaken to improve HRQL, symptoms, treatment adherence, knowledge, and self-efficacy in youth with JIA. The proposed "Managing JIA Online" Trial will rigorously examine the effects of this Internet intervention on HRQL and other health outcomes thereby filling a significant gap in our knowledge related to promotion of self-management care for adolescents with JIA.
- Conditions
- Arthritis, Juvenile Idiopathic
- Being tested
- Taking Charge: Managing JIA Online, Standard Medical Care and JIA Resource Center
- Keywords
- adoloescent, internet self-management, managing JIA
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taking Charge: Managing JIA OnlineBehavioural
In addition to standard medical care, adolescents in the experimental group will receive the "Taking Charge: Managing JIA Online" Internet self-management program. The intervention is a 12-module interactive multi-component treatment protocol - that consists of JIA-specific education, self-management strategies, and social support - that is available in English and French.
Standard Medical Care and JIA Resource CenterBehavioural
The control group is designed to control for the potential effects on outcomes of time, attention and computer use during the intervention and through the 9-month follow-up period. In addition to standard medical care, adolescents in the attention control group will be provided with access to a self-guided patient education study website, which will have two components: basic patient educational materials about JIA ("JIA Resource Centre") and online assessments.
| Study group | Role | What they receive |
|---|---|---|
| Taking Charge Experimental Group | Experimental | Not described Receives: Behavioral: Taking Charge: Managing JIA Online |
| Control Group | Active comparator | Not described Receives: Behavioral: Standard Medical Care and JIA Resource Center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain will be measured using the Recalled Pain Inventory - Short Form.91 The RPI measures current as well as least, average and worst pain intensity, pain unpleasantness, and pain interference ratings over the past week with items rated on a 11-point numerical rating scale (NRS) (e.g., 0 = 'no pain' to 10 = 'severe pain') and painful body locations. This 11-item measure has evidence of construct validity
Measured: 12 months
Health-related Quality of Life (HRQL)
HRQL will be measured using the teen and parent PedsQL Rheumatology Modules.13 Both of the PedsQL rheumatology modules contain a 22-item self-report and parent scale with five subscales: pain and hurt, daily activities, treatment, worry, and communication.
Measured: Baseline
Pain
Pain will be measured using the Recalled Pain Inventory - Short Form.91 The RPI measures current as well as least, average and worst pain intensity, pain unpleasantness, and pain interference ratings over the past week with items rated on a 11-point numerical rating scale (NRS) (e.g., 0 = 'no pain' to 10 = 'severe pain') and painful body locations. This 11-item measure has evidence of construct validity
Measured: Baseline
Pain
Pain will be measured using the Recalled Pain Inventory - Short Form.91 The RPI measures current as well as least, average and worst pain intensity, pain unpleasantness, and pain interference ratings over the past week with items rated on a 11-point numerical rating scale (NRS) (e.g., 0 = 'no pain' to 10 = 'severe pain') and painful body locations. This 11-item measure has evidence of construct validity
Measured: 3months
Health-related Quality of Life (HRQL)
HRQL will be measured using the teen and parent PedsQL Rheumatology Modules.13 Both of the PedsQL rheumatology modules contain a 22-item self-report and parent scale with five subscales: pain and hurt, daily activities, treatment, worry, and communication.
Measured: 6 months
Pain
Pain will be measured using the Recalled Pain Inventory - Short Form.91 The RPI measures current as well as least, average and worst pain intensity, pain unpleasantness, and pain interference ratings over the past week with items rated on a 11-point numerical rating scale (NRS) (e.g., 0 = 'no pain' to 10 = 'severe pain') and painful body locations. This 11-item measure has evidence of construct validity
Measured: 6 months
Health-related Quality of Life (HRQL)
HRQL will be measured using the teen and parent PedsQL Rheumatology Modules.13 Both of the PedsQL rheumatology modules contain a 22-item self-report and parent scale with five subscales: pain and hurt, daily activities, treatment, worry, and communication.
Measured: 3 months
Health-related Quality of Life (HRQL)
HRQL will be measured using the teen and parent PedsQL Rheumatology Modules.13 Both of the PedsQL rheumatology modules contain a 22-item self-report and parent scale with five subscales: pain and hurt, daily activities, treatment, worry, and communication.
Measured: 12 months
Secondary outcomes (5)
Emotional Symptoms
Anxiety and depression will each be assessed using two, separate 8-item PROMIS (Patient Reported Outcomes Measurement Information System) scales.
Measured: Baseline, 3 months, 6 months and 12 months post-intervention
Adherence
Adherence to medical treatment will be assessed using the 34-item Child Adherence Report Questionnaire (CARQ)
Measured: Baseline, 3 months, 6 months and 12 months post-intervention
Pain Coping
Pain coping will be measured using the 18-item Pain Coping Questionnaire106, which is an internationally used measure of pain coping strategies in the pediatric population and has been validated in youth with arthritis.
Measured: Baseline, 3 months, 6 months and 12 months post-intervention
Juvenile Idiopathic Arthritis (JIA)
JIA-specific knowledge will be measured using 9-items from the Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS).
Measured: Baseline, 3 months, 6 months and 12 months post-intervention
Self-Efficacy
Self-efficacy will be measured using the Children's Arthritis Self-Efficacy (CASE) scale which is an 11-item measure.
Measured: Baseline, 3 months, 6 months and 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionMar 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, Juvenile IdiopathicStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Stinson, The Hospital for Sick Children
- Investigators
- Jennifer N Stinson, RN, PhD, CPNP, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572896
- Sponsor's protocol ID
- 1000028028
- Status last verified
- Mar 2017
- First submitted
- 3 Apr 2012
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stinson JN, Lalloo C, Hundert AS, Campillo S, Cellucci T, Dancey P, Duffy C, Ellsworth J, Feldman BM, Huber AM, Johnson N, Jong G, Oen K, Rosenberg AM, Shiff NJ, Spiegel L, Tse SML, Tucker L, Victor JC. Teens Taking Charge: A Randomized Controlled Trial of a Web-Based Self-Management Program With Telephone Support for Adolescents With Juvenile Idiopathic Arthritis. J Med Internet Res. 2020 Jul 29;22(7):e16234. doi: 10.2196/16234.
PubMed 32723728
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Internet-based Self-management Program for Adolescents With Arthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01572896
- Acronym / sponsor ID
- 1000028028
- Conditions
- Arthritis, Juvenile Idiopathic
- Keywords
- adoloescent, internet self-management, managing JIA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 6 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the effectiveness of the "Taking Charge: Managing JIA Online" Internet intervention, when compared with an attention (static education only websites) control group in improving pain and HRQL as well as other health outcomes (anxiety, depression, treatment adherence, pain coping, knowledge, and self-efficacy) in adolescents with JIA. The proposed study will enroll and randomize 294 adolescents with JIA attending 10 pediatric rheumatology hospital clinics in the Canada to either the experimental or control groups.
Detailed description
In summary, no rigorous Internet self-management intervention has been undertaken to improve HRQL, symptoms, treatment adherence, knowledge, and self-efficacy in youth with JIA. The proposed "Managing JIA Online" Trial will rigorously examine the effects of this Internet intervention on HRQL and other health outcomes thereby filling a significant gap in our knowledge related to promotion of self-management care for adolescents with JIA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taking Charge Experimental Group | Experimental | Behavioral: Taking Charge: Managing JIA Online |
| Control Group | Active comparator | Behavioral: Standard Medical Care and JIA Resource Center |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age ≥12 and ≤ 18 years.
- Diagnosed with JIA (using International League of Associations for Rheumatology classification criteria)83 by their rheumatologist.
- Adolescents and parent/ primary caregiver are able to speak and read either English or French.
- Participants are willing and able to complete online measures. There will be no restrictions on medication use for this study.
Key exclusion criteria (5 listed)
- Cognitive impairments (as assessed by reviewing medical chart and consultation with the patient's rheumatologist)
- Major co-morbid illnesses which may mitigate HRQL assessment
- Adolescents that are currently participating in other CBT interventions.
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 |
|---|---|---|
| Taking Charge: Managing JIA OnlineIn addition to standard medical care, adolescents in the experimental group will receive the "Taking Charge: Managing JIA Online" Internet self-management program. The intervention is a 12-module interactive multi-component treatment protocol - that consists of JIA-specific education, self-management strategies, and social support - that is available in English and French. | Behavioural | Taking Charge Experimental Group |
| Standard Medical Care and JIA Resource CenterThe control group is designed to control for the potential effects on outcomes of time, attention and computer use during the intervention and through the 9-month follow-up period. In addition to standard medical care, adolescents in the attention control group will be provided with access to a self-guided patient education study website, which will have two components: basic patient educational materials about JIA ("JIA Resource Centre") and online assessments. | Behavioural | Control Group |
Primary outcome
Pain
Time frame: 12 months
Pain will be measured using the Recalled Pain Inventory - Short Form.91 The RPI measures current as well as least, average and worst pain intensity, pain unpleasantness, and pain interference ratings over the past week with items rated on a 11-point numerical rating scale (NRS) (e.g., 0 = 'no pain' to 10 = 'severe pain') and painful body locations. This 11-item measure has evidence of construct validity
Health-related Quality of Life (HRQL)
Time frame: Baseline
HRQL will be measured using the teen and parent PedsQL Rheumatology Modules.13 Both of the PedsQL rheumatology modules contain a 22-item self-report and parent scale with five subscales: pain and hurt, daily activities, treatment, worry, and communication.
Pain
Time frame: Baseline
Pain will be measured using the Recalled Pain Inventory - Short Form.91 The RPI measures current as well as least, average and worst pain intensity, pain unpleasantness, and pain interference ratings over the past week with items rated on a 11-point numerical rating scale (NRS) (e.g., 0 = 'no pain' to 10 = 'severe pain') and painful body locations. This 11-item measure has evidence of construct validity
Pain
Time frame: 3months
Pain will be measured using the Recalled Pain Inventory - Short Form.91 The RPI measures current as well as least, average and worst pain intensity, pain unpleasantness, and pain interference ratings over the past week with items rated on a 11-point numerical rating scale (NRS) (e.g., 0 = 'no pain' to 10 = 'severe pain') and painful body locations. This 11-item measure has evidence of construct validity
Health-related Quality of Life (HRQL)
Time frame: 6 months
HRQL will be measured using the teen and parent PedsQL Rheumatology Modules.13 Both of the PedsQL rheumatology modules contain a 22-item self-report and parent scale with five subscales: pain and hurt, daily activities, treatment, worry, and communication.
Pain
Time frame: 6 months
Pain will be measured using the Recalled Pain Inventory - Short Form.91 The RPI measures current as well as least, average and worst pain intensity, pain unpleasantness, and pain interference ratings over the past week with items rated on a 11-point numerical rating scale (NRS) (e.g., 0 = 'no pain' to 10 = 'severe pain') and painful body locations. This 11-item measure has evidence of construct validity
Health-related Quality of Life (HRQL)
Time frame: 3 months
HRQL will be measured using the teen and parent PedsQL Rheumatology Modules.13 Both of the PedsQL rheumatology modules contain a 22-item self-report and parent scale with five subscales: pain and hurt, daily activities, treatment, worry, and communication.
Health-related Quality of Life (HRQL)
Time frame: 12 months
HRQL will be measured using the teen and parent PedsQL Rheumatology Modules.13 Both of the PedsQL rheumatology modules contain a 22-item self-report and parent scale with five subscales: pain and hurt, daily activities, treatment, worry, and communication.
5 secondary outcomes
Emotional Symptoms
Time frame: Baseline, 3 months, 6 months and 12 months post-intervention
Adherence
Time frame: Baseline, 3 months, 6 months and 12 months post-intervention
Pain Coping
Time frame: Baseline, 3 months, 6 months and 12 months post-intervention
Juvenile Idiopathic Arthritis (JIA)
Time frame: Baseline, 3 months, 6 months and 12 months post-intervention
Self-Efficacy
Time frame: Baseline, 3 months, 6 months and 12 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Derived from this study: PubMed 32723728Stinson JN, Lalloo C, Hundert AS, Campillo S, Cellucci T, Dancey P, Duffy C, Ellsworth J, Feldman BM, Huber AM, Johnson N, Jong G, Oen K, Rosenberg AM, Shiff NJ, Spiegel L, Tse SML, Tucker L, Victor JC. Teens Taking Charge: A Randomized Controlled Trial of a Web-Based Self-Management Program With Telephone Support for Adolescents With Juvenile Idiopathic Arthritis. J Med Internet Res. 2020 Jul 29;22(7):e16234. doi: 10.2196/16234.
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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.
Jennifer N Stinson, RN, PhD, CPNP principal investigator
The Hospital for Sick Children
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taking Charge: Managing JIA Online and Standard Medical Care and JIA Resource Center in people with Arthritis, Juvenile Idiopathic, run by The Hospital for Sick Children at 11 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 5 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 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain (time frame: 12 months). The study lists 8 primary outcomes in all. 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 NCT01572896, 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 4 Apr 2017; AzTrials last refreshed its copy on 2 Nov 2026.