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NCT00423631 · ClinicalTrials.gov registry record · NA
Web-based Education to Enhance Fibromyalgia Management
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 118
- Enrollment target
NCT00423631 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 118 participants.
The verdict
NCT00423631, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 118 participants
- Enrollment target
Study Summary
Fibromyalgia (FMS) a condition marked by pain, fatigue, and memory complaints, is considered a chronic condition and is most commonly treated or managed using medications. Previous studies have found benefit in adding cognitive-behavioral therapy (CBT), a non-medication intervention, to standard care in order to obtain better outcomes in terms of improved functional status and symptom reduction. While the addition of CBT to standard care has been shown to be beneficial, it is not a form of therapy that is widely available to patients with FMS. CBT includes a variety of skills that can be taught to patients to help in the management of chronic illnesses. This protocol will examine the relative merits of providing these CBT skills to patients via an informational website. The website will contain the content of CBT, a social support capability, and data transfer capabilities. The addition of this website to standard care will be compared to standard care alone. This study is interested in assessing improvements in physical functional status, the symptoms of FMS, and the relative costs of the interventions as compared to the savings in health care utilization over a 6-month period. Primary Hypothesis The primary hypothesis of this study is that the number of patients with fibromyalgia who are able to achieve clinically meaningful improvements in physical function will be greater when standard symptom-based pharmacological care is augmented by CBT skills delivered through an educational website. Secondary Hypotheses 1. The proportion of patients with fibromyalgia who are able to achieve clinically meaningful improvements in symptoms of FMS such as pain, fatigue, and perceived cognitive difficulties will be greater when standard symptom-based pharmacological care is augmented by CBT skills delivered through an educational website 2. The proportion of patients with fibromyalgia who are able to achieve clinically meaningful improvements in mood and beliefs about pain wi
Interventions
- BEHAVIORAL Standard Care
- BEHAVIORAL Standard care and web
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2006-09 |
| Est. Completion | 2008-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00423631
The ClinicalTrials.gov registry entry for NCT00423631 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard Care is the first listed.
NCT00423631 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00423631 about?
NCT00423631 is a clinical study titled "Web-based Education to Enhance Fibromyalgia Management". Fibromyalgia (FMS) a condition marked by pain, fatigue, and memory complaints, is considered a chronic condition and is most commonly treated or managed using medications. Previous studies have found benefit in adding cognitive-behavioral therapy (CBT), a non-medication intervention, to standard car...
What is the current status of trial NCT00423631?
This trial is currently completed. It is a NA study. The enrollment target is 118 participants. The study started on 2006-09. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00423631?
The interventions under investigation include: Standard Care (BEHAVIORAL), Standard care and web (BEHAVIORAL).
Who is sponsoring clinical trial NCT00423631?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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