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Promoting Health in People With Fibromyalgia

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00167271
First received: September 9, 2005
Last updated: February 18, 2011
Last verified: February 2011
History of Changes
  Purpose

Body worn sensors and the Internet can be used to self-monitor daily behavior and promote a healthier lifestyle in women with fibromyalgia.


Condition Intervention
Fibromyalgia
 Behavioral: Cognitive Behavior Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Computer and SenseWear Technologies for Promoting Health in People With Fibromyalgia: A Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Fibromyalgia Impact Questionnaire, symptom reduction [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Queries about symptoms


Enrollment: 72
Study Start Date: October 2002
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
Computerized cognitive, behavioral therapy with Body Media armband to collect data about activity, which subjects could review each evening.
 Behavioral: Cognitive Behavior Therapy
Experimental: Computerized cognitive, behavioral therapy with Body Media armband to collect data about activity, which subjects could review each evening.
Other Name: Control
Active Comparator: Control
Subjects given pamphlets from the Arthritis Foundation
 Behavioral: Cognitive Behavior Therapy
Experimental: Computerized cognitive, behavioral therapy with Body Media armband to collect data about activity, which subjects could review each evening.
Other Name: Control

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."

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00167271

Locations
United States, Pennsylvania
Subjects' homes
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
U.S. Department of Education
Investigators
Principal Investigator: Joan C. Rogers, Ph.D. University of Pittsburgh
  More Information

No publications provided

Responsible Party: Joan C. Rogers, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00167271     History of Changes
Other Study ID Numbers: 020771
Study First Received: September 9, 2005
Last Updated: February 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Cognitive therapy

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013