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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014