Trial Outcomes & Findings for Internet Self-Management Program With Telephone Support for Adolescents With Arthritis (NCT NCT01011179)
NCT ID: NCT01011179
Last Updated: 2021-03-29
Results Overview
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.
COMPLETED
NA
46 participants
Baseline (prior to randomization) and 3 months after intervention
2021-03-29
Participant Flow
Participants were recruited from 4 pediatric, rheumatology clinics located within tertiary care centers across Canada. Adolescent participants were recruited between October and November 2008.
Participant milestones
| Measure |
Attention Control Group
Self-Management : Adolescents' "own best efforts" at managing their JIA
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
22
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Internet Self-Management Program With Telephone Support for Adolescents With Arthritis
Baseline characteristics by cohort
| Measure |
Attention Control Group
n=24 Participants
Self-Management : Adolescents' "own best efforts" at managing their JIA
|
Internet-based JIA Self-Management Program
n=22 Participants
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.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
24 participants
n=5 Participants
|
22 participants
n=7 Participants
|
46 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (prior to randomization) and 3 months after interventionThe 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.
Outcome measures
| Measure |
Internet-based JIA Self-Management Program
n=22 Participants
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.
|
Attention Control Group
n=24 Participants
Self-Management: Adolescents' "own best efforts" at managing their JIA
|
|---|---|---|
|
Juvenile Arthritis Quality of Life Questionnaire (JAQQ)
Baseline
|
2.35 units on a scale
Standard Deviation 1.34
|
2.74 units on a scale
Standard Deviation 1.36
|
|
Juvenile Arthritis Quality of Life Questionnaire (JAQQ)
Post-intervention
|
1.95 units on a scale
Standard Deviation 1.40
|
2.27 units on a scale
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: 3 months after interventionMeasure looks at disease specific knowledge. Subscale used: Medical Issues Subscale scores range from 0 (min) - 10 (max) with higher scores indicating greater knowledge.
Outcome measures
| Measure |
Internet-based JIA Self-Management Program
n=24 Participants
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.
|
Attention Control Group
n=22 Participants
Self-Management: Adolescents' "own best efforts" at managing their JIA
|
|---|---|---|
|
Medical Issues Sub-Scale From Medical Issues, Exercise, Pain, and Social Support Questionnaire (MEPS)
|
4.16 score on a scale
Standard Deviation 1.96
|
6.98 score on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: Baseline (prior to randomization) and 3 months after interventionPopulation: Data was not collected for this measure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months after interventionMeasure looks at Self-efficacy. Subscales: Activity, Emotion, Family. Subscale scores range 0 - 10 with higher scores indicating greater self-efficacy.
Outcome measures
| Measure |
Internet-based JIA Self-Management Program
n=24 Participants
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.
|
Attention Control Group
n=22 Participants
Self-Management: Adolescents' "own best efforts" at managing their JIA
|
|---|---|---|
|
Children's Arthritis Self-Efficacy Scale (CASE)
Symptom Standard Score
|
6.55 score on a scale
Standard Deviation 2.75
|
7.47 score on a scale
Standard Deviation 1.89
|
|
Children's Arthritis Self-Efficacy Scale (CASE)
Emotional Standard Score
|
8.11 score on a scale
Standard Deviation 2.22
|
7.96 score on a scale
Standard Deviation 2.38
|
|
Children's Arthritis Self-Efficacy Scale (CASE)
Activity Standard Score
|
7.60 score on a scale
Standard Deviation 2.72
|
7.88 score on a scale
Standard Deviation 2.42
|
SECONDARY outcome
Timeframe: 3 months after interventionMeasure 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.
Outcome measures
| Measure |
Internet-based JIA Self-Management Program
n=24 Participants
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.
|
Attention Control Group
n=22 Participants
Self-Management: Adolescents' "own best efforts" at managing their JIA
|
|---|---|---|
|
Child Adherence Report Questionnaire (CARQ)
Medication
|
7.5 score on a scale
Standard Deviation 2.96
|
8.14 score on a scale
Standard Deviation 8.14
|
|
Child Adherence Report Questionnaire (CARQ)
Exercise
|
4.68 score on a scale
Standard Deviation 3.26
|
5.05 score on a scale
Standard Deviation 3.78
|
SECONDARY outcome
Timeframe: 3 months after interventionMeasure examines stress. Total score calculated was an average of all items with a range from 1-4 with higher scores indicating greater stress.
Outcome measures
| Measure |
Internet-based JIA Self-Management Program
n=24 Participants
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.
|
Attention Control Group
n=22 Participants
Self-Management: Adolescents' "own best efforts" at managing their JIA
|
|---|---|---|
|
Perceived Stress Questionnaire (PSQ)
|
2.13 score on a scale
Standard Deviation 0.42
|
1.98 score on a scale
Standard Deviation 0.42
|
Adverse Events
Attention Control Group
Internet-based JIA Self-Management Program
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place