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| Sponsor: | University of Utah |
|---|---|
| Collaborators: |
National Institutes of Health (NIH) National Center for Complementary and Alternative Medicine (NCCAM) |
| Information provided by (Responsible Party): | University of Utah |
| ClinicalTrials.gov Identifier: | NCT00983502 |
Purpose
The investigators' long-term goal is to identify, and then provide general practitioners with evidence-based recommendations for therapeutic interventions for unexplained chronic fatigue (UCF). The investigators' central hypothesis guiding this application is that some complimentary and alternative medicine (CAM) practitioners have developed management approaches that are more helpful to patients with UCF than usual care.
| Condition |
|---|
|
Idiopathic Chronic Fatigue Chronic Fatigue Syndrome Myalgic Encephalomyelitis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Pilot Study of Alternative Treatments of Unexplained Chronic Fatigue |
| Enrollment: | 154 |
| Study Start Date: | August 2008 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Integrative Medicine
Patients of MD practitioners trained in Complementary and Alternative Medicine
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Naturopath Doctors
Patients of practitioners who are not MD's and are trained in Naturopathic Medicine
|
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Chronic Fatigue Specialists
Patients of MD's who specialize in treating Chronic Fatigue and related conditions
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Control Group
Patients treated by primary care MDs in practice-based research networks
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An objective is to identify certain types of clinicians (or individual physicians) who appear to have identified effective treatments for patients with UCF, or to find that clinicians who report themselves to be effective are not. Study subjects will be UCF patients new to the practice of one of four groups of participating clinicians: 1) a control group of MDs in practice-based research networks, 2) MDs trained in CAM, 3) naturopathic doctors (non MDs trained in special naturopathic schools), and 4) MDs who specialize in chronic fatigue. Our rationale for this comparison is that its successful completion will potentially guide future searches for effective medical strategies for the treatment of UCF that may have been developed outside the mainstream medical community. It may also provide necessary information for follow-up studies that will help to identify specific effective treatments. This information includes which clinicians provide the best treatments (as evidenced by having patients with the best results), what are the characteristics of patients who respond to a particular treatment, how the data collection procedures might need to be refined and what sample sizes are necessary.
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
The primary analyses will compare outcomes for 240 patients in four main groups (60 in each group) defined by the background of the treating clinicians. Study subjects will be UCF patients new to the practice of one of four groups of participating clinicians.
Inclusion Criteria:
Exclusion Criteria:
No known history of:
Contacts and Locations| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84112 | |
| Principal Investigator: | Arthur J Hartz, MD, PhD | Huntsman Cancer Institute, University of Utah |
More Information
| Responsible Party: | University of Utah |
| ClinicalTrials.gov Identifier: | NCT00983502 History of Changes |
| Other Study ID Numbers: | 25988, R21 AT004537-02 |
| Study First Received: | September 22, 2009 |
| Last Updated: | December 13, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Idiopathic Chronic Fatigue Chronic Fatigue Syndrome Myalgic encephalomyelitis |
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Encephalomyelitis Fatigue Fatigue Syndrome, Chronic Encephalitis Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Central Nervous System Infections Signs and Symptoms Virus Diseases Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases |