A Study to Compare Two Ways of Completing Pain and Sleep Questions and to Evaluate a New Daily Questionaire for Assessing Fatigue in Fibromyalgia Patients

February 12, 2010 updated by: Pfizer

A Non-Drug Methodology Study To Explore The Psychometric Properties Of A Daily Diary Of Fatigue Symptoms And To Compare Two Modes Of Administration Of Pain And Sleep Interference Questions For Use With Fibromyalgia Patients

The study has two goals. The first goal of the study is to compare two methods of administering questions about pain and sleep interference. The two methods being compared are a telephone based system and an electronic hand held diary. The second goal of the study is to evaluate a daily diary to evaluate fatigue symptoms in patients with fibromyalgia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

185

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
    • California
      • Roseville, California, United States, 95661
        • Pfizer Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Pfizer Investigational Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Pfizer Investigational Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Pfizer Investigational Site
      • St. Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Pfizer Investigational Site
    • New York
      • Johnson City, New York, United States, 13790
        • Pfizer Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Pfizer Investigational Site
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
        • Pfizer Investigational Site
      • New Tazewell, Tennessee, United States, 37825
        • Pfizer Investigational Site
    • Texas
      • Lake Jackson, Texas, United States, 77566
        • Pfizer Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23294
        • Pfizer Investigational Site
    • Washington
      • Spokane, Washington, United States, 99216
        • Pfizer Investigational Site

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:

  • Fibromyalgia using ACR diagnosis

Exclusion Criteria:

  • Other confounding disease including other inflammatory disease, pain and depression

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

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Interactive Voice Response System
Other: Interactive Voice Response System (IVRS)
Telephone based system
Other: Personal Digital Assisstant
Other: Personal Digital Assisstant (PDA)
Electronic Hand Held diary

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Daily questions about pain asked using a telephone based system and a hand held diary
Time Frame: 4 weeks
4 weeks
Daily questions about sleep asked using a telephone based system and a hand held diary
Time Frame: 4 weeks
4 weeks
Daily questions about fatigue asked hand held electronic diary
Time Frame: 2 weeks
2 weeks
Questionaires about pain, fatigue, function, quality of life, patients impression of change and diary ease of use
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Questionaires about sleep, mood and fibromyalgia severity
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

January 1, 2009

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

January 7, 2009

First Submitted That Met QC Criteria

January 8, 2009

First Posted (Estimate)

January 9, 2009

Study Record Updates

Last Update Posted (Estimate)

February 15, 2010

Last Update Submitted That Met QC Criteria

February 12, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A9001393

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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