Promoting Health in People With Fibromyalgia

February 18, 2011 updated by: University of Pittsburgh

Efficacy of Computer and SenseWear Technologies for Promoting Health in People With Fibromyalgia: A Randomized Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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."

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • Subjects' homes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibromyalgia Impact Questionnaire, symptom reduction
Time Frame: 6 weeks
Queries about symptoms
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

U.S. Department of Education

Investigators

  • Principal Investigator: Joan C. Rogers, Ph.D., University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

February 21, 2011

Last Update Submitted That Met QC Criteria

February 18, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 020771

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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