i.e.
http://clinicaltrials.gov/ct2/show/NCT00983502?cond=%22Chronic+Fatigue+Syndr
ome%22&rcv_d=14
Pilot Study of Alternative Treatments of Unexplained Chronic Fatigue
This study is currently recruiting participants.
Verified by University of Utah, September 2009
First Received: September 22, 2009 Last Updated: September 23, 2009
History of Changes
Sponsors and Collaborators: University of Utah
National Institutes of Health (NIH)
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: 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: Cohort, Prospective
Official Title: Pilot Study of Alternative Treatments of Unexplained Chronic
Fatigue
Resource links provided by NLM:
MedlinePlus related topics: Chronic Fatigue Syndrome
U.S. FDA Resources
Further study details as provided by University of Utah:
Primary Outcome Measures:
.Differences among four groups of clinicians with respect to patient
treatment outcome [ Time Frame: Six months ] [ Designated as safety issue:
No ]
Biospecimen Retention: None Retained
Biospecimen Description:
Estimated Enrollment: 240
Study Start Date: August 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for
primary outcome measure)
Groups/Cohorts
Integrative Medicine
Patients of MD practitioners trained in Complementary and Alternative
Medicine
Naturopath Doctors
Patients of practitioners who are not MD's and are trained in Naturopathic
Medicine
Chronic Fatigue Specialists
Patients of MD's who specialize in treating Chronic Fatigue and related
conditions
Control Group
Patients treated by primary care MDs in practice-based research networks
Detailed Description:
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
Study Population
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.
Criteria
Inclusion Criteria:
1.Age 21 through 65.
2.Has severe debilitating fatigue that substantially reduces the quality of
life.
3.Does not have any organic, psychological, or lifestyle problems that are
the primary disorder and are likely to be the cause of this fatigue (see
exclusionary criteria)
4.The severe, unexplained fatigue has persisted for at least six months.
5.Has not been previously treated by current physician for chronic fatigue.
6.Can speak and read English.
7.Is not pregnant or planning to become pregnant within six months.
8.Has a telephone.
Exclusion Criteria:
No known history of:
1.Bipolar disorder
2.Psychosis
3.Major Depressive Disorder
4.Sleep disorder
5.Anemia
6.Thyroid disease
7.Rheumatoid Arthritis
8.Systemic Lupus
9.Cancer
10.Heart disease
11.Liver disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00983502
Contacts
Contact: Arthur J Hartz, MD, PhD arthur.hartz@hci.utah.edu
Contact: Kathleen OConnor, MS kathleen.oconnor@hci.utah.edu
Locations
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Kate Hak kate.hak@hci.utah.edu
Contact: Kathleen OConnor, MS kathleen.oconnor@hci.utah.edu
Principal Investigator: Arthur J Hartz, MD, PhD
Sponsors and Collaborators
University of Utah
National Institutes of Health (NIH)
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Principal Investigator: Arthur J Hartz, MD, PhD Huntsman Cancer Institute,
University of Utah
More Information
Additional Information:
Study website
No publications provided
Responsible Party: Huntsman Cancer Institute, University of Utah ( Arthur
Hartz, MD, PhD, Director Health Services Research )
Study ID Numbers: 25988, R21 AT004537-02
Study First Received: September 22, 2009
Last Updated: September 23, 2009
ClinicalTrials.gov Identifier: NCT00983502 History of Changes
Health Authority: United States: Institutional Review Board
Keywords provided by University of Utah:
Idiopathic Chronic Fatigue
Chronic Fatigue Syndrome
Myalgic encephalomyelitis
Additional relevant MeSH terms:
Disease
Fatigue
Nervous System Diseases
Central Nervous System Diseases
Encephalomyelitis
Fatigue Syndrome, Chronic
Brain Diseases
Encephalitis
Virus Diseases
Signs and Symptoms
Pathologic Processes
Muscular Diseases
Neuromuscular Diseases
Central Nervous System Infections
Musculoskeletal Diseases
Syndrome
ClinicalTrials.gov processed this record on October 18, 2009
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