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| Name | Class |
|---|---|
| Canadian Arthritis Patient Alliance | OTHER |
| Provincial Health Services Authority British Columbia | OTHER |
| Dalhousie University | OTHER |
| IWK Health Centre |
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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet-based JIA Self-Management Program | Experimental |
| |
| Attention Control Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teens Taking Charge | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pain Coping (Pain Coping Questionnaire) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick J McGrath, MD | IWK Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Children's Hospital | Vancouver | British Columbia | Canada | |||
| IWK Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20595280 | Result | 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. |
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Participants were recruited from 4 pediatric, rheumatology clinics located within tertiary care centers across Canada. Adolescent participants were recruited between October and November 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Attention Control Group | Self-Management : Adolescents' "own best efforts" at managing their JIA |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Attention Control Group | Self-Management : Adolescents' "own best efforts" at managing their JIA |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline (prior to randomization) and 3 months after intervention |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Attention Control Group | Self-Management : Adolescents' "own best efforts" at managing their JIA |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Stinson | The Hospital for Sick Children | 416-813-7654 | 304514 | jennifer.stinson@sickkids.ca |
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| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000073278 | Self-Management |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| OTHER |
| The Arthritis Society, Canada | OTHER |
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|
| Self-Management | Behavioral | Adolescents' "own best efforts" at managing their JIA |
|
| 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. | 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. | 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. | 3 months after intervention |
| Halifax |
| Nova Scotia |
| Canada |
| The Hospital for Sick Children | Toronto | Ontario | Canada |
| Montreal Children's Hospital | Montreal | Quebec | Canada |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Attention Control Group | Self-Management: Adolescents' "own best efforts" at managing their JIA |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months after intervention |
|
|
|
| Secondary | Pain Coping (Pain Coping Questionnaire) | Data was not collected for this measure | Posted | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months after intervention |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | 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. | 0 | 22 | 0 | 22 |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Activity Standard Score |
|