Efficacy of Web-based Pain Self-management for Adolescents With Juvenile Idiopathic Arthritis

WebSMART: Efficacy of Web-based Pain Self-management for Adolescents With Juvenile Idiopathic Arthritis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01541917

Acronym

WebSMART

Enrollment

305

Registered

2012-03-01

Start date

2012-07-31

Completion date

2016-06-30

Last updated

2017-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Juvenile Idiopathic Arthritis

Brief summary

The purpose of this multi-site randomized clinical trial is to determine if an online coping skills training program will produce superior improvements in pain and health-related quality of life outcomes for adolescents with JIA relative to outcomes attained with reviewing online educational information about JIA.

Detailed description

There is a critical gap in the contemporary treatment of Juvenile Idiopathic Arthritis (JIA) wherein a majority of adolescent patients still experience ongoing pain and reduced health-related quality of life even with advances in medical management of the disease. Despite the pervasiveness of this problem, most adolescents receive no training in the strategies that can help empower them to reduce pain and disability. The Internet offers a unique opportunity to reach adolescents with JIA and provide the training in pain self-management strategies that otherwise may not occur due to treatment access and resource obstacles. The objective of this research study is to conduct a definitive test of an investigator-developed online coping skills training program for English- and Spanish-speaking adolescents with JIA. Based on data from the investigators' preliminary work, the central hypothesis is that use of an online coping skills training program will produce superior improvements in pain and health-related quality of life outcomes for adolescents with JIA relative to outcomes attained with reviewing extant online educational information about JIA and receiving additional attention to coping efforts (control condition). Specific aims for the proposed work include (a) determining the extent to which an online coping skills training program for adolescents with JIA produces improvements in key health outcomes that currently do not optimally respond to only contemporary medical management (pain and health-related quality of life); and (b) determining predictors of change in pain and health-related quality of life indices in adolescents with JIA and establishing the extent to which online coping skills training influences health outcomes via these predictors. An exploratory aim is to determine the acceptability and preliminary efficacy of online coping skills training within a subgroup of Hispanic adolescents with JIA. These aims will be achieved through the approach of using a multi-center randomized controlled trial in which a sample of 360 consenting English- and Spanish-speaking adolescents aged 12-18 years with JIA will be enrolled and randomized into one of two groups: (a) an experimental group consisting of a 12-week interactive online multi-component treatment protocol including targeted disease education, training in empirically supported cognitive-behavioral coping skills, and social support augmented by monthly telephone contact with a nurse; or (b) a control group consisting of 12 weeks of guided access to extant online resources for disease education and additional attention to own best efforts at managing JIA via monthly telephone contact with a nurse. Outcome data will be collected from both groups prior to treatment, immediately following the intervention, and at 6- and 12-month follow-up assessments. Successful completion of this project is expected to establish to what extent and how an innovative online self-management program produces change in clinically relevant health outcomes in both English- and Spanish-speaking adolescents with JIA. The proposed study therefore can be expected to have a significant positive impact in the healthcare of teens with JIA and in identifying treatment targets for other youth self-management interventions.

Interventions

BEHAVIORALWeb-based coping skills training

This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.

BEHAVIORALOnline disease education

The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse health coach to discuss the participant's efforts at managing his/her disease.

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

Inclusion criteria

* 12-18 years of age (inclusive) * diagnosed with JIA by a pediatric rheumatologist * able to speak and read English and/or Spanish * able to complete online measures * reporting pain in at least one joint over the past 6 months

Exclusion criteria

* have another chronic medical condition that adversely impacts pain and/or health-related quality of life (e.g., inflammatory bowel disease, fibromyalgia, cancer, genetic disorder, pervasive developmental disorder, diabetes) * have a significant cognitive impairment or illiteracy that would prevent understanding of the intervention and outcome measures * currently in psychotherapy

Design outcomes

Primary

Measure	Time frame	Description
Change in Pain Intensity	Baseline, post-treatment, 6-month follow-up, 12-month follow-up	Pain intensity was assessed by patient-self report using an electronic numeric rating scale ranging from 0-10, with 0 being the lowest value (no pain) and 10 being the highest value (very much pain).
Change in PedsQL Rheumatology Health-Related Quality of Life Total Score	Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up	Health-related quality of life was measured by patient self-report using an electronic version of the PedsQL Rheumatology Module. Responses on this scale are transformed into a 0-100 scale, with 0 being the worst value for health-related quality of life and 100 being the best possible value for health-related quality of life.

Secondary

Measure	Time frame	Description
Change in Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS) Education Score	Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up	Knowledge about Juvenile Idiopathic Arthritis was measured by patient self-report using an electronic version of the Medical Issues, Exercise, Pain and Social support (MEPS) Questionnaire. Responses on this scale are measured on a 0-10 numeric rating scale and averaged together to form a summary score, with 0 being the worst possible score and 10 being the best possible score.
Change in Disease Activity	Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up	Disease activity was assessed by the treating physician based on a complete joint count (count of the number of joints that are swollen, painful, tender, or restriction in motion). The lowest (best) value is 0, and the highest (worst) possible value is 300.
Change in Children's Arthritis Self-Efficacy (CASE) Scores	Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up	Confidence in managing arthritis was measured by patient self-report using an electronic version of the Children's Arthritis Self-Efficacy (CASE) scale. Responses on a 5-point scale (not at all sure to very sure) are averaged together to form a total score, with 0 being the worst possible value and 5 being the best possible value.
Change in Approach Coping	Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up	Scores on the Approach Coping sub-scale of the Pain Coping Questionnaire were used to measure approach coping, which is a type of coping considered to be adaptive and helpful for pain. Responses to items on this subscale are on a 5-point scale (never use to very often use) and are averaged together for the subscale score, such that scores range from a worst possible value of 1 to a best possible value of 5.

Countries

United States

Participant flow

Pre-assignment details

For this trial, 305 patients consented (were enrolled) to participate, but 7 of these patients subsequently were found to not fully meet eligibility criteria and 9 of these patients dropped out prior to being randomized. The total randomized sample therefore is 289.

Participants by arm

Arm	Count
Web-based Coping Skills Training This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach to review material and help enhance motivation.	144
Online Disease Education Control The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual health coach to discuss the participant's efforts at managing his/her disease.	145
Never Randomized This group comprises participants that consented but were never randomized to a condition due to being determined to not meet eligibility criteria or self-withdrawing before randomization.	16
Total	305

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	2	2
Overall Study	Withdrawal by Subject	13	7

Baseline characteristics

Characteristic	Web-based Coping Skills Training	Online Disease Education Control	Never Randomized	Total
Age, Continuous	14.65 years STANDARD_DEVIATION 1.85	14.55 years STANDARD_DEVIATION 1.76	15.06 years STANDARD_DEVIATION 1.69	14.59 years STANDARD_DEVIATION 1.79
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants	17 Participants	1 Participants	39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	123 Participants	128 Participants	15 Participants	266 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants	0 Participants	0 Participants	3 Participants
Race (NIH/OMB) Asian	5 Participants	5 Participants	0 Participants	10 Participants
Race (NIH/OMB) Black or African American	7 Participants	5 Participants	1 Participants	13 Participants
Race (NIH/OMB) More than one race	9 Participants	10 Participants	2 Participants	21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	2 Participants	0 Participants	2 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	120 Participants	123 Participants	13 Participants	256 Participants
Sex: Female, Male Female	98 Participants	111 Participants	13 Participants	222 Participants
Sex: Female, Male Male	46 Participants	34 Participants	3 Participants	83 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	38 / 144	34 / 145
serious Total, serious adverse events	4 / 144	5 / 145

Outcome results

Primary

Change in Pain Intensity

Pain intensity was assessed by patient-self report using an electronic numeric rating scale ranging from 0-10, with 0 being the lowest value (no pain) and 10 being the highest value (very much pain).

Time frame: Baseline, post-treatment, 6-month follow-up, 12-month follow-up

Population: All randomized patients were analyzed regardless of whether or not they completed treatment (intent to treat analyses).

Arm	Measure	Group	Value (MEAN)	Dispersion
Web-based Coping Skills Training	Change in Pain Intensity	Baseline	3.56 Units on a scale	Standard Deviation 2.33
Web-based Coping Skills Training	Change in Pain Intensity	Post-Treatment	3.07 Units on a scale	Standard Deviation 2.47
Web-based Coping Skills Training	Change in Pain Intensity	6-Month Follow-Up	2.87 Units on a scale	Standard Deviation 2.45
Web-based Coping Skills Training	Change in Pain Intensity	12-Month Follow-Up	3.07 Units on a scale	Standard Deviation 2.49
Online Disease Education Control	Change in Pain Intensity	12-Month Follow-Up	2.71 Units on a scale	Standard Deviation 2.43
Online Disease Education Control	Change in Pain Intensity	Baseline	3.26 Units on a scale	Standard Deviation 2.38
Online Disease Education Control	Change in Pain Intensity	6-Month Follow-Up	2.96 Units on a scale	Standard Deviation 2.29
Online Disease Education Control	Change in Pain Intensity	Post-Treatment	2.90 Units on a scale	Standard Deviation 2.45

Comparison: Multilevel growth model evaluating average change over time (regardless of group) on the outcome variablep-value: <0.00195% CI: [-0.06, -0.02]Multilevel growth model

Comparison: Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.p-value: 0.5195% CI: [-0.055, 0.027]Multilevel growth model

Primary

Change in PedsQL Rheumatology Health-Related Quality of Life Total Score

Health-related quality of life was measured by patient self-report using an electronic version of the PedsQL Rheumatology Module. Responses on this scale are transformed into a 0-100 scale, with 0 being the worst value for health-related quality of life and 100 being the best possible value for health-related quality of life.