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Promoting Health in People With Fibromyalgia

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT00167271
Collaborator
U.S. Department of Education (U.S. Fed)
72
Enrollment
1
Location
2
Arms
49
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Behavior Therapy
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Computer and SenseWear Technologies for Promoting Health in People With Fibromyalgia: A Randomized Clinical Trial
Study Start Date :
Oct 1, 2002
Actual Primary Completion Date :
Nov 1, 2006
Actual Study Completion Date :
Nov 1, 2006

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Fibromyalgia Impact Questionnaire, symptom reduction [6 weeks]

      Queries about symptoms

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00167271
    Other Study ID Numbers:
    • 020771
    First Posted:
    Sep 14, 2005
    Last Update Posted:
    Feb 21, 2011
    Last Verified:
    Feb 1, 2011
    Keywords provided by , ,
    Cognitive therapy
    Additional relevant MeSH terms:
    Fibromyalgia
    Myofascial Pain Syndromes

    Study Results

    No Results Posted as of Feb 21, 2011