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
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
1 other identifier
interventional
185
1 country
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2009
Shorter than P25 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 7, 2009
CompletedFirst Posted
Study publicly available on registry
January 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFebruary 15, 2010
February 1, 2010
2 months
January 7, 2009
February 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Daily questions about pain asked using a telephone based system and a hand held diary
4 weeks
Daily questions about sleep asked using a telephone based system and a hand held diary
4 weeks
Daily questions about fatigue asked hand held electronic diary
2 weeks
Questionaires about pain, fatigue, function, quality of life, patients impression of change and diary ease of use
4 weeks
Secondary Outcomes (1)
Questionaires about sleep, mood and fibromyalgia severity
4 weeks
Study Arms (2)
Interactive Voice Response System
OTHERPersonal Digital Assisstant
OTHERInterventions
Telephone based system
Eligibility Criteria
You may qualify if:
- Fibromyalgia using ACR diagnosis
You may not qualify if:
- Other confounding disease including other inflammatory disease, pain and depression
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (15)
Pfizer Investigational Site
Roseville, California, 95661, United States
Pfizer Investigational Site
Baton Rouge, Louisiana, 70809, United States
Pfizer Investigational Site
North Dartmouth, Massachusetts, 02747, United States
Pfizer Investigational Site
Jefferson City, Missouri, 65109, United States
Pfizer Investigational Site
St Louis, Missouri, 63141, United States
Pfizer Investigational Site
Omaha, Nebraska, 68114, United States
Pfizer Investigational Site
Johnson City, New York, 13790, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45219, United States
Pfizer Investigational Site
Johnson City, Tennessee, 37601, United States
Pfizer Investigational Site
New Tazewell, Tennessee, 37825, United States
Pfizer Investigational Site
Lake Jackson, Texas, 77566, United States
Pfizer Investigational Site
Charlottesville, Virginia, 22911, United States
Pfizer Investigational Site
Richmond, Virginia, 23294, United States
Pfizer Investigational Site
Spokane, Washington, 99216, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 7, 2009
First Posted
January 9, 2009
Study Start
January 1, 2009
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
February 15, 2010
Record last verified: 2010-02