Promoting Health in People With Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavior Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Cognitive therapy
Eligibility Criteria
Inclusion Criteria: be at least 18 years of age meet the American College of Rheumatology criteria for fibromyalgia diagnosed with fibromyalgia at least 1 year prior to admission to the study have sufficient vision to operate a computer be English speaking have a private telephone line Exclusion Criteria: live beyond a 40 mile radius of Pittsburgh
Sites / Locations
- Subjects' homes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Control
Arm Description
Computerized cognitive, behavioral therapy with Body Media armband to collect data about activity, which subjects could review each evening.
Subjects given pamphlets from the Arthritis Foundation
Outcomes
Primary Outcome Measures
Fibromyalgia Impact Questionnaire, symptom reduction
Queries about symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT00167271
First Posted
September 9, 2005
Last Updated
February 18, 2011
Sponsor
University of Pittsburgh
Collaborators
U.S. Department of Education
1. Study Identification
Unique Protocol Identification Number
NCT00167271
Brief Title
Promoting Health in People With Fibromyalgia
Official Title
Efficacy of Computer and SenseWear Technologies for Promoting Health in People With Fibromyalgia: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Pittsburgh
Collaborators
U.S. Department of Education
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Body worn sensors and the Internet can be used to self-monitor daily behavior and promote a healthier lifestyle in women with fibromyalgia.
Detailed Description
Fibromyalgia is among the most common diffuse pain syndromes, affecting about 1 of every 10 rheumatology patients. People with fibromyalgia experience widespread chronic pain and fatigue that negatively influences their activity participation (causes disability) and overall quality of life.
The purpose of this 3-year study is to use a cognitive-behavioral intervention to facilitate adoption of a wellness lifestyle in people with fibromyalgia. Specifically, we will test the efficacy of a health promotion computer program (Balance Center) used in conjunction with a wearable sensor (SenseWearTM) for developing a wellness lifestyle and improving the quality of life of adults with fibromyalgia. Balance Center software is a health promotion computer program that helps consumers to: (1) establish goals in the areas of physical activity, nutrition, participation in meaningful, productive activities, sleep, stress-reducing activities, and emotional state; (2) monitor progress toward established goals; and, (3) assess the relationship between these areas in one's daily life. In addition, based on consumer input, it offers suggestions for developing a wellness lifestyle. SenseWearTM, provides objective data about activity level and stress level for consumers to use in combination with the self-assessment data provided by the Balance Center.
In this randomized controlled clinical trial, the Experimental (Balance Center + SenseWearTM) Intervention is compared to a Usual Care, control group. Seventy-two adults (36 = Experimental; 36 = Control) with fibromyalgia will be randomized and followed for 6 weeks, exclusive of Baseline and Posttesting. The hypotheses to be tested are: Participants randomized to the Experimental Condition will demonstrate significantly (a) more physical activity, (b) a healthier, wellness lifestyle, and (c) fewer symptoms of fibromyalgia. In addition, the relationship between the decrease in fibromyalgia-related impairment on daily life and physical activity and a wellness lifestyle will be stronger at Posttesting than at Baseline in the Experimental Group, compared to the Control Group. The anticipated outcome of the intervention is more effective self-management of lifestyle and symptoms so that one can "live well with fibromyalgia."
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Cognitive therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Computerized cognitive, behavioral therapy with Body Media armband to collect data about activity, which subjects could review each evening.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Subjects given pamphlets from the Arthritis Foundation
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy
Other Intervention Name(s)
Control
Intervention Description
Experimental: Computerized cognitive, behavioral therapy with Body Media armband to collect data about activity, which subjects could review each evening.
Primary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire, symptom reduction
Description
Queries about symptoms
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
be at least 18 years of age
meet the American College of Rheumatology criteria for fibromyalgia
diagnosed with fibromyalgia at least 1 year prior to admission to the study
have sufficient vision to operate a computer
be English speaking
have a private telephone line
Exclusion Criteria:
live beyond a 40 mile radius of Pittsburgh
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan C. Rogers, Ph.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Subjects' homes
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Promoting Health in People With Fibromyalgia
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