Juvenile Idiopathic Arthritis
Conditions
Keywords
Teens Taking Charge, Managing Arthritis Online, juvenile idiopathic arthritis, internet, self-management
Brief 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).
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
Interventions
BEHAVIORALTeens 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.
BEHAVIORALSelf-Management
Adolescents' own best efforts at managing their JIA
Sponsors
Canadian Arthritis Patient Alliance
Provincial Health Services Authority British Columbia
Dalhousie University
IWK Health Centre
The Arthritis Society, Canada
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Juvenile Arthritis Quality of Life Questionnaire (JAQQ) | 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
| Measure | Time frame | Description |
|---|---|---|
| Medical Issues Sub-Scale From Medical Issues, Exercise, Pain, and Social Support Questionnaire (MEPS) | 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. |
| Pain Coping (Pain Coping Questionnaire) | Baseline (prior to randomization) and 3 months after intervention | — |
| Children's Arthritis Self-Efficacy Scale (CASE) | 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. |
| Child Adherence Report Questionnaire (CARQ) | 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. |
| Perceived Stress Questionnaire (PSQ) | 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. |
Countries
Canada
Participant flow
Recruitment details
Participants were recruited from 4 pediatric, rheumatology clinics located within tertiary care centers across Canada. Adolescent participants were recruited between October and November 2008.
Participants by arm
| Arm | Count |
|---|---|
| Attention Control Group Self-Management : Adolescents' own best efforts at managing their JIA | 24 |
| Internet-based JIA Self-Management Program 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. | 22 |
| Total | 46 |
Baseline characteristics
| Characteristic | Attention Control Group | Internet-based JIA Self-Management Program | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 24 Participants | 22 Participants | 46 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Canada | 24 participants | 22 participants | 46 participants |
| Sex: Female, Male Female | 16 Participants | 15 Participants | 31 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 22 |
| serious Total, serious adverse events | 0 / 24 | 0 / 22 |
Outcome results
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.
Time frame: Baseline (prior to randomization) and 3 months after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet-based JIA Self-Management Program | Juvenile Arthritis Quality of Life Questionnaire (JAQQ) | Baseline | 2.35 units on a scale | Standard Deviation 1.34 |
| Internet-based JIA Self-Management Program | Juvenile Arthritis Quality of Life Questionnaire (JAQQ) | Post-intervention | 1.95 units on a scale | Standard Deviation 1.4 |
| Attention Control Group | Juvenile Arthritis Quality of Life Questionnaire (JAQQ) | Baseline | 2.74 units on a scale | Standard Deviation 1.36 |
| Attention Control Group | Juvenile Arthritis Quality of Life Questionnaire (JAQQ) | Post-intervention | 2.27 units on a scale | Standard Deviation 1.21 |
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.
Time frame: 3 months after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet-based JIA Self-Management Program | Child Adherence Report Questionnaire (CARQ) | Medication | 7.5 score on a scale | Standard Deviation 2.96 |
| Internet-based JIA Self-Management Program | Child Adherence Report Questionnaire (CARQ) | Exercise | 4.68 score on a scale | Standard Deviation 3.26 |
| Attention Control Group | Child Adherence Report Questionnaire (CARQ) | Medication | 8.14 score on a scale | Standard Deviation 8.14 |
| Attention Control Group | Child Adherence Report Questionnaire (CARQ) | Exercise | 5.05 score on a scale | Standard Deviation 3.78 |
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.
Time frame: 3 months after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet-based JIA Self-Management Program | Children's Arthritis Self-Efficacy Scale (CASE) | Activity Standard Score | 7.60 score on a scale | Standard Deviation 2.72 |
| Internet-based JIA Self-Management Program | Children's Arthritis Self-Efficacy Scale (CASE) | Symptom Standard Score | 6.55 score on a scale | Standard Deviation 2.75 |
| Internet-based JIA Self-Management Program | Children's Arthritis Self-Efficacy Scale (CASE) | Emotional Standard Score | 8.11 score on a scale | Standard Deviation 2.22 |
| Attention Control Group | Children's Arthritis Self-Efficacy Scale (CASE) | Symptom Standard Score | 7.47 score on a scale | Standard Deviation 1.89 |
| Attention Control Group | Children's Arthritis Self-Efficacy Scale (CASE) | Emotional Standard Score | 7.96 score on a scale | Standard Deviation 2.38 |
| Attention Control Group | Children's Arthritis Self-Efficacy Scale (CASE) | Activity Standard Score | 7.88 score on a scale | Standard Deviation 2.42 |
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.
Time frame: 3 months after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Internet-based JIA Self-Management Program | Medical Issues Sub-Scale From Medical Issues, Exercise, Pain, and Social Support Questionnaire (MEPS) | 4.16 score on a scale | Standard Deviation 1.96 |
| Attention Control Group | Medical Issues Sub-Scale From Medical Issues, Exercise, Pain, and Social Support Questionnaire (MEPS) | 6.98 score on a scale | Standard Deviation 1.08 |
Secondary
Pain Coping (Pain Coping Questionnaire)
Time frame: Baseline (prior to randomization) and 3 months after intervention
Population: Data was not collected for this measure
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.
Time frame: 3 months after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Internet-based JIA Self-Management Program | Perceived Stress Questionnaire (PSQ) | 2.13 score on a scale | Standard Deviation 0.42 |
| Attention Control Group | Perceived Stress Questionnaire (PSQ) | 1.98 score on a scale | Standard Deviation 0.42 |