FibromyalgiaNCT00222690
Living With Fibromyalgia: Triggers,Subgroups, and a Cognitive-Behavioral and Interactive Technology-Based Intervention
An observational study of Fibromyalgia, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to conduct semi-structured qualitative interviews to examine the personal experiences of women living with fibromyalgia. The specific aims of this study are to identify clinically relevant "triggers" of fibromyalgia symptoms and examine their impact on activity limitations and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibromyalgia
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jun 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1)At least 18 years of age; (2) meet the American College of Rheumatology (ACR) criteria for FM as diagnosed by a physician; (3) have been diagnosed with FM at least 1 year prior to admission to the study; (4) have sufficient vision, based on a functional vision test (i.e., read newsprint) to operate a computer program; (5) speak English; and (6) have a private telephone line.
Who cannot join
- (1)Living beyond a 40-mile radius from the Oakland campus of the University of Pittsburgh. (2)Disability in everyday tasks related to a diagnosis other than FM (e.g., stroke, Parkinson disease) will also be grounds for exclusion.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh - Department of Occupational Therapy
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Living With Fibromyalgia (FM): Triggers,Clinical Subgroups, and the Effects Of A Self-Monitored Cognitive-Behavioral and Interactive Technology-Based Intervention on Clinical Subgroups
The purpose of this study is to conduct semi-structured qualitative interviews to examine the personal experiences of women living with fibromyalgia. The specific aims of this study are to identify clinically relevant "triggers" of fibromyalgia symptoms and examine their impact on activity limitations and participation restrictions.
Read the detailed description
Fibromyalgia (FM) may currently be the most common rheumatic diagnosis of rheumatologists among their female patients, with 15-20% of all new rheumatology referrals meeting the 1990 American College of Rheumatology (ACR) diagnosis criteria for fibromyalgia. People with fibromyalgia live through widespread musculoskeletal chronic pain, fatigue, psychological distress, and exhibit diminished physical performance due in part to the cycle of pain that adversely affect their activity participation and overall well-being.
The purpose of this prospective mixed methods study is to conduct semi-structured qualitative interviews using ethnographic techniques to examine the personal experiences of women living with fibromyalgia. The specific aims of this study are to identify clinically relevant "triggers" of fibromyalgia symptoms and examine their impact on activity limitations and participation restrictions.
- Conditions
- Fibromyalgia
- Keywords
- qualitative interview, symptom triggers, activity and participation
- Medical subject headings
- Fibromyalgia, Motor Activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- SHRS Research Development Fund, U.S. Department of Education
- Investigators
- Hazel L Breland, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222690
- Sponsor's protocol ID
- 0505178
- Status last verified
- Sep 2005
- First submitted
- 14 Sep 2005
- Last updated
- 29 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living With Fibromyalgia (FM): Triggers,Clinical Subgroups, and the Effects Of A Self-Monitored Cognitive-Behavioral and Interactive Technology-Based Intervention on Clinical Subgroups
- ClinicalTrials.gov ID
- NCT00222690
- Acronym / sponsor ID
- 0505178
- Conditions
- Fibromyalgia
- Keywords
- qualitative interview, symptom triggers, activity and participation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- SHRS Research Development Fund, U.S. Department of Education
- Study start
- Jun 2005
- Study completion
- Jun 2006
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to conduct semi-structured qualitative interviews to examine the personal experiences of women living with fibromyalgia. The specific aims of this study are to identify clinically relevant "triggers" of fibromyalgia symptoms and examine their impact on activity limitations and participation restrictions.
Detailed description
Fibromyalgia (FM) may currently be the most common rheumatic diagnosis of rheumatologists among their female patients, with 15-20% of all new rheumatology referrals meeting the 1990 American College of Rheumatology (ACR) diagnosis criteria for fibromyalgia. People with fibromyalgia live through widespread musculoskeletal chronic pain, fatigue, psychological distress, and exhibit diminished physical performance due in part to the cycle of pain that adversely affect their activity participation and overall well-being.
The purpose of this prospective mixed methods study is to conduct semi-structured qualitative interviews using ethnographic techniques to examine the personal experiences of women living with fibromyalgia. The specific aims of this study are to identify clinically relevant "triggers" of fibromyalgia symptoms and examine their impact on activity limitations and participation restrictions.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1)At least 18 years of age; (2) meet the American College of Rheumatology (ACR) criteria for FM as diagnosed by a physician; (3) have been diagnosed with FM at least 1 year prior to admission to the study; (4) have sufficient vision, based on a functional vision test (i.e., read newsprint) to operate a computer program; (5) speak English; and (6) have a private telephone line.
Key exclusion criteria (1 listed)
- (1)Living beyond a 40-mile radius from the Oakland campus of the University of Pittsburgh. (2)Disability in everyday tasks related to a diagnosis other than FM (e.g., stroke, Parkinson disease) will also be grounds for exclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hazel L Breland, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2006.