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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00983502
Other study ID # 25988
Secondary ID R21AT004537-02
Status Terminated
Phase N/A
First received September 22, 2009
Last updated December 13, 2011
Start date August 2008
Est. completion date October 2010

Study information

Verified date December 2011
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 154
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 65 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
United States University of Utah Salt Lake City Utah

Sponsors (3)

Lead Sponsor Collaborator
University of Utah National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Differences among four groups of clinicians with respect to patient treatment outcome Six months No
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