Idiopathic Chronic FatigueNCT00983502
Pilot Study of Alternative Treatments of Unexplained Chronic Fatigue
An observational study of Idiopathic Chronic Fatigue and Chronic Fatigue Syndrome, run by University of Utah at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Chronic Fatigue, Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Oct 2010
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age 21 through 65.
- Has severe debilitating fatigue that substantially reduces the quality of life.
- 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)
- The severe, unexplained fatigue has persisted for at least six months.
- Has not been previously treated by current physician for chronic fatigue.
- Can speak and read English.
- Is not pregnant or planning to become pregnant within six months.
- Has a telephone.
Who cannot join
- No known history of:
- Bipolar disorder
- Psychosis
- Major Depressive Disorder
- Sleep disorder
- Anemia
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- Thyroid disease
- Rheumatoid Arthritis
- Systemic Lupus
- Cancer
- Heart disease
- Liver disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Keywords
- Idiopathic Chronic Fatigue, Chronic Fatigue Syndrome, Myalgic encephalomyelitis
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences among four groups of clinicians with respect to patient treatment outcome
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2009 (estimated)
- Study startAug 2008
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: IRB ended and NIH study ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Chronic FatigueStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Arthur J Hartz, MD, PhD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983502
- Sponsor's protocol ID
- 25988
- Other IDs
- R21AT004537-02
- Status last verified
- Dec 2011
- First submitted
- 22 Sep 2009
- Last updated
- 15 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Alternative Treatments of Unexplained Chronic Fatigue
- ClinicalTrials.gov ID
- NCT00983502
- Acronym / sponsor ID
- 25988
- Keywords
- Idiopathic Chronic Fatigue, Chronic Fatigue Syndrome, Myalgic encephalomyelitis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: IRB ended and NIH study ended
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Aug 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 24 Sep 2009 (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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Age 21 through 65.
- Has severe debilitating fatigue that substantially reduces the quality of life.
- 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)
- The severe, unexplained fatigue has persisted for at least six months.
- Has not been previously treated by current physician for chronic fatigue.
Key exclusion criteria (12 listed)
- Bipolar disorder
- Psychosis
- Major Depressive Disorder
- Sleep disorder
- Anemia
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
Differences among four groups of clinicians with respect to patient treatment outcome
Time frame: Six months
Results and safety
The study was stopped early (reason given: IRB ended and NIH study ended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2011.
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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.
Arthur J Hartz, MD, PhD principal investigator
Huntsman Cancer Institute
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 Idiopathic Chronic Fatigue and Chronic Fatigue Syndrome, run by University of Utah 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 8 inclusion and 12 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: stopped early, as of the sponsor's last update on 15 Dec 2011. 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 was stopped early (reason given: IRB ended and NIH study ended). Results are not available in the source record.
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.
What does the primary outcome measure?
Differences among four groups of clinicians with respect to patient treatment outcome (time frame: Six months). It is what the study was designed to measure, not a finding.
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 15 Dec 2011.