Healthier Living With Arthritis Online Program | NCT00398255

Studies
Healthier Living With Arthritis Online Program

NCT00398255

Sponsor

Stanford University

Status

Completed

Last Update Posted

Apr 30, 2013Estimated

Enrollment

900

Phase

Not Applicable

Conditions

Osteoarthritis
Rheumatoid Arthritis
Fibromyalgia

Interventions

self-management program

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

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

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2004

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Nov 9, 2006

First Submission Date that Met QC Criteria

Nov 9, 2006

First Posted Date

Nov 10, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2013

Last Update Posted Date

Apr 30, 2013Estimated

Description Module

Brief Summary

Individuals with with arthritic conditions (rheumatoid arthritis, osteoarthritis, or fibromyalgia) and internet and email access were randomized to receive an internet-based arthritis self-management program (treatment group) or to continue with usual care (control group). Questionnaires measuring health indicators, health behaviors, self efficacy and health care utilization were administered at baseline, six months and one year after the course. It was hypothesized that those participating in the course would have better outcomes than the control group at six months and one year.

Detailed Description

An internet-based arthritis self-management program was developed based on the widely used small-group arthritis self-management program. Individuals with arthritis were recruited via established websites, on-line newsletters, discussion groups, calendar announcements and articles in newspapers, and asked to go to the project website. Subjects who filled out an informed consent and met all of the following criteria were invited to enroll:

At least 18 years of age
A physician's diagnosis of osteoarthritis, rheumatoid arthritis or fibromyalgia.
Not have been in active treatment for cancer for one year.
Not participated in the small group Arthritis Self-Management or Chronic Disease Self-Management Program

Those eligible and wishing to continue were randomized to receive the internet-based arthritis self-management program (treatment group) or to continue with usual care (control group). On-line questionnaires were administered at baseline, six months and twelve months after the program. Measures included health indicators, health behaviors, self efficacy and health care utilization. It is hypothesized that course participants, compared to the usual-care control group, will show statistically significant improvements (using Analyses of Covariance and Logistic Regressions) in outcome variables and that the improvements will be associated with increased self-efficacy for management of arthritis.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

900

Name	Type	Description	Arm Group Labels	Other Names
self-management program	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Health Distress Scale at six months and one year
Activities Limitation Scale at six months and one year
Self Efficacy for Management of Arthritis Scale at six months and one year
Stretching and strengthening exercise at six months and one year
Visits of Physicians at six months and one year

Secondary Outcomes

Measure	Description	Time Frame
Self-Reported General Health at six months and one year
Visual Numeric Pain at six months and one year
Visual Numeric Fatigue at six months and one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

arthritic condition (osteoarthritis, rheumatoid arthritis or fibromyalgia)
internet access and ability to use computer

Exclusion Criteria:

active treatment for cancer
taken small group arthritis self-management program

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kate R. Lorig, DrPh	Stanford School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine Patient Education Center		Palo Alto	California	94305	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18576310	Derived	Lorig KR, Ritter PL, Laurent DD, Plant K. The internet-based arthritis self-management program: a one-year randomized trial for patients with arthritis or fibromyalgia. Arthritis Rheum. 2008 Jul 15;59(7):1009-17. doi: 10.1002/art.23817.

ID	Term
D010003	Osteoarthritis
D001172	Arthritis, Rheumatoid
D005356	Fibromyalgia
D001168	Arthritis

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases

ID	Term
D012046	Rehabilitation
D006296	Health Services
D005159	Health Care Facilities Workforce and Services