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Discovering Trends in Chronic Fatigue Syndrome Patients' Clinical Study Experiences

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05967494
Recruitment Status : Not yet recruiting
First Posted : August 1, 2023
Last Update Posted : August 1, 2023
Sponsor:
Information provided by (Responsible Party):
Power Life Sciences Inc.

Brief Summary:

The study seeks to delve into the firsthand experiences of patients diagnosed with chronic fatigue syndrome who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals.

The data collected from this study will help improve future outcomes for all chronic fatigue syndrome patients as well as those in under-represented demographic groups.


Condition or disease
Chronic Fatigue Syndrome

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Assessing Patient Engagement and Understanding in Chronic Fatigue Syndrome Clinical Trials
Estimated Study Start Date : August 2024
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : August 2026





Primary Outcome Measures :
  1. Rate of patients who decide to join in a chronic fatigue syndrome clinical trial [ Time Frame: 3 months ]
  2. Number of chronic fatigue syndrome patients who remain in clinical trial until completion [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronic fatigue syndrome who are actively considering enrolling in a clinical study, but have not yet completed enrollment and randomization.
Criteria

Inclusion Criteria:

  • Signed Written Informed Consent
  • Aged ≥ 18 years old
  • No prior treatment for chronic fatigue syndrome

Exclusion Criteria:

  • Participant is actively receiving study therapy in another
  • Inability to provide written informed consent
  • Women of childbearing potential without a negative pregnancy test; or women who are lactating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05967494


Contacts
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Contact: Michael B Gill (415) 900-4227 bask@withpower.com

Locations
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United States, California
Power Life Sciences
San Francisco, California, United States, 94107
Contact: Michael B Gill    415-900-4227    https://www.withpower.com/contact-us@withpower.com   
Sponsors and Collaborators
Power Life Sciences Inc.
Investigators
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Study Director: Michael B Gill Power Life Sciences Inc.
  Study Documents (Full-Text)

Documents provided by Power Life Sciences Inc.:
Informed Consent Form  [PDF] July 21, 2023

Publications:
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Responsible Party: Power Life Sciences Inc.
ClinicalTrials.gov Identifier: NCT05967494    
Other Study ID Numbers: 84606875
First Posted: August 1, 2023    Key Record Dates
Last Update Posted: August 1, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Power Life Sciences Inc.:
Chronic Fatigue Syndrome
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Syndrome
Fatigue
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Neuroinflammatory Diseases
Nervous System Diseases
Neuromuscular Diseases
Chronic Disease
Disease Attributes