Efficacy of Web-based Pain Self-management for Adolescent... | NCT01541917

NCT01541917

ID	Type	Description	Link
1R01AR061513-01	U.S. NIH Grant/Contract		View source

Status Module

Sponsor/Collaborators Module

Name	Class
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	NIH

Oversight Module

Description Module

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.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Web-based coping skills training	Experimental	Involves completion of a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support.	Behavioral: Web-based coping skills training
Online disease education	Active Comparator	Involves viewing 12 educational websites about Juvenile Idiopathic Arthritis over the course of 12 weeks.	Behavioral: Online disease education

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Web-based coping skills training	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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").	Baseline, post-treatment, 6-month follow-up, 12-month follow-up
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.	Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up

Secondary Outcomes

Measure	Description	Time Frame
Change in Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS) Education Score	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.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Mark A Connelly, PhD	Children's Mercy Hospital Kansas City	Principal Investigator
Jennifer Stinson, PhD	The Hospital for Sick Children	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of California San Francisco Benioff Children's Hospital		San Francisco	California	94143	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Web-based Coping Skills Training	Involves completion of a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. 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 (research nurse) to review material and help enhance motivation.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG000144 BG001145 BG00216 BG003305

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00014.65± 1.85 BG00114.55± 1.76 BG00215.06± 1.69 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00098 BG001111 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00021 BG00117 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0003 BG0010 BG002

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

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").

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

Posted

Mean

Standard Deviation

Units on a scale

Baseline, post-treatment, 6-month follow-up, 12-month follow-up

ID	Title	Description
OG000	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 (research nurse) to review material and help enhance motivation.
OG001	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 nurse "health coach" to discuss the participant's efforts at managing his/her disease.

Units	Counts
Participants	OG000144 OG001145

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0003.56± 2.33 OG0013.26± 2.38

Post-Treatment

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Multilevel growth model evaluating average change over time (regardless of group) on the outcome variable	Multilevel growth model	Adjusted for baseline values	<.001		Slope	-.04	Standard Error of the Mean	.01	2-Sided	95	-.06	-.02			The parameter represents the average monthly change on the outcome variable since group procedures were initiated.		Superiority or Other

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.

Posted

Mean

Standard Deviation

units on a scale

Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up

ID	Title	Description
OG000	Web-based Coping Skills Training	Involves completion of a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. 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 (research nurse) to review material and help enhance motivation.
OG001	Online Disease Education	Involves viewing 12 educational websites about Juvenile Idiopathic Arthritis over the course of 12 weeks. Online 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.

Secondary

Change in Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS) Education Score

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.

Posted

Mean

Standard Deviation

units on a scale

Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up

ID	Title	Description
OG000	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 (research nurse) to review material and help enhance motivation.
OG001	Online 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.

Secondary

Change in Disease Activity

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.

Posted

Mean

Standard Deviation

joints

Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up

ID	Title	Description
OG000	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 (research nurse) to review material and help enhance motivation.
OG001	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 nurse "health coach" to discuss the participant's efforts at managing his/her disease.

Secondary

Change in Children's Arthritis Self-Efficacy (CASE) Scores

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.

Posted

Mean

Standard Deviation

units on a scale

Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up

ID	Title	Description
OG000	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 (research nurse) to review material and help enhance motivation.
OG001	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 nurse "health coach" to discuss the participant's efforts at managing his/her disease.

Secondary

Change in Approach Coping

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.

Posted

Mean

Standard Deviation

units on a scale

Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up

ID	Title	Description
OG000	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 (research nurse) to review material and help enhance motivation.
OG001	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 nurse "health coach" to discuss the participant's efforts at managing his/her disease.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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 (research nurse) to review material and help enhance motivation.			4	144	38	144
EG001	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 nurse "health coach" to discuss the participant's efforts at managing his/her disease.			5	145	34	145

Serious Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Hospitalization	Gastrointestinal disorders	Systematic Assessment	Hospitalized for evaluation of abdominal pain.	EG0001 events1 affected144 at risk EG0014 events3 affected145 at risk
Arthritis flare	Musculoskeletal and connective tissue disorders	Systematic Assessment	Admitted to hospital for management of arthritis flare	EG0001 events1 affected144 at risk EG0010 events0 affected145 at risk
Hospitalized for macrophage activation syndrome	Infections and infestations	Systematic Assessment		EG0000 events0 affected144 at risk EG0011 events1 affected145 at risk
Hospitalized for appendicitis	Infections and infestations	Systematic Assessment		EG0000 events0 affected144 at risk EG0011 events1 affected145 at risk
Hospitalized for management of Crohn's disease flare	Immune system disorders	Systematic Assessment		EG0001 events1 affected144 at risk EG0010 events0 affected145 at risk
Hospitalized for suicidal thoughts	Psychiatric disorders	Systematic Assessment		EG0001 events1 affected144 at risk EG0010 events0 affected145 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Skin system findings (psoriasis, rash)	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0006 events5 affected144 at risk EG0014 events3 affected145 at risk
Injury (e.g., sprain, fracture)	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected144 at risk EG0013 events3 affected145 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0018 events7 affected145 at risk
Infection	Infections and infestations	Systematic Assessment	EG0007 events7 affected144 at risk EG00111 events11 affected145 at risk
Blood disorder/problems	Blood and lymphatic system disorders	Systematic Assessment	EG0003 events3 affected144 at risk EG0012 events2 affected145 at risk
Dizziness and/or fatigue	Nervous system disorders	Systematic Assessment	EG0002 events2 affected144 at risk EG0012 events2 affected145 at risk
Arthritis flare	Immune system disorders	Systematic Assessment	EG00018 events13 affected144 at risk EG0014 events4 affected145 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0003 events3 affected144 at risk EG0011 events1 affected145 at risk
Suicidal thoughts	Psychiatric disorders	Systematic Assessment	EG0002 events2 affected144 at risk EG0011 events1 affected145 at risk

ID	Term
D001171	Arthritis, Juvenile

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Units	Counts
Participants	OG000144 OG001145