Patient-Centered Assessment of Symptoms and Outcomes
2 other identifiers
observational
692
1 country
1
Brief Summary
Background: The cause of fatigue is not well understood. It can be felt differently by different people. Some people think there are different types of fatigue, with different causes. Researchers think a therapy to treat one type of fatigue in one condition should be able to treat that type of fatigue in other conditions. Objective: To understand the types of fatigue. Eligibility: Adults 18 and older who have felt fatigue for more than a month, and non-fatigued adults Design: Participants will be screened with a physical exam, their medical history, a vision test, and blood and urine tests. Participants will begin to track the foods they eat. This study will involve up to 10 visits. Each visit will last no more than 4 hours. In Stage 1, participants will have an interview, fill out questionnaires, and play computer games. They will take walking and handgrip tests. They will give blood, urine, and saliva samples. They will wear a wrist monitor at home for 7 days and write down their activities. They will be put into a group: fatigue or non-fatigued control. In Stage 2, participants will answer questionnaires and give a blood sample. They will have heart tests. They may take exercise and lung function tests that include wearing a nose clip. They may have an optional brain MRI: They may wear an electrode cap on their head during the scan to measure brain activity. They will lie on table that slides into a cylinder. They may perform tasks in the scanner. After the study, participants might be contacted about other studies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2019
CompletedFirst Posted
Study publicly available on registry
May 16, 2019
CompletedStudy Start
First participant enrolled
September 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
May 1, 2026
April 29, 2026
6.7 years
May 15, 2019
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fatigue Level
The primary outcome will be the fatigue level using the Fatigue Numeric Rating Scale (FNS) score.
Stage 1 and Stage 2
Secondary Outcomes (1)
Secondary outcomes of the study will obtain common fatigue dimension information from participants that will allow us to better define phenotypic clusters that ultimately can be used for hypothesis generation, these include patient-reported outc...
All time points
Study Arms (2)
Control
FNS \<= 3
Fatigued
FNS \>= 4
Eligibility Criteria
Participants will be recruited via a stepwise approach. Limited recruitment will occur during the first 6 months to 12 months after initial IRB approval, as part of the feasibility assessment. During this time, NIH investigators such as those from NINR, the NIDCR Sjogren s Clinic, and the 16-N-0058 study (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome) will be informed about the study. These investigators will not actively recruit their own patients for the study but will be asked to post a recruitment flyer in their clinics. After the first year, the study will open to the general population.
You may qualify if:
- All Participants (including returning participants)
- Adult participants aged \>= 18 years at the time of enrollment.
- Able to provide written informed consent.
- Willing and able to complete study procedures.
- Fatigued Participants
- In addition to the above, must experience fatigue for more than a month.
- Healthy Volunteers for the fMRI study
- Right handed
- Not taking any prescribed medications for chronic medical conditions
- Not diagnosed with any chronic medical condition
You may not qualify if:
- Not fluent in English.
- Have medical health issues that create additional and substantial adverse risks related to study procedures. Medical examples are the acute complications of medical disease, such as unstable hypertension, diabetic ketoacidosis, symptomatic hyperthyroidism, and unstable angina.
- Have a psychiatric condition that prevents participant from being able to reliably report the fatigue experience (e.g., a psychotic disorder with severely disorganized thinking);
- Categorized as a high-risk drinker (\>=5 drinks/day and \>=15 drinks/week for men, \>=4 drinks/day and \>=8 drinks/week for women). ( Dietary Guidelines for Americans 2015-2020," U.S. Department of Health and Human Services and U.S. Department of Agriculture).
- NIH employees.
- Pregnant or lactating women.
- Ongoing medical condition that is deemed by the Principal Investigator to interfere with the conduct or assessments of the study or safety of the participant.
- fMRI Technical Development Sub-Study
- Implanted cardiac pacemakers, metal aneurysm clips;
- Broken bones repaired with metal pins, screws, rods, plates;
- Prosthetic eye implants;
- Transdermal medications or infusion pumps;
- Bullet fragments or other metal pieces in body from old wounds;
- Significant work exposure to metal particles;
- Clinically relevant claustrophobia;
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (3)
Saligan LN, Olson K, Filler K, Larkin D, Cramp F, Yennurajalingam S, Escalante CP, del Giglio A, Kober KM, Kamath J, Palesh O, Mustian K; Multinational Association of Supportive Care in Cancer Fatigue Study Group-Biomarker Working Group. The biology of cancer-related fatigue: a review of the literature. Support Care Cancer. 2015 Aug;23(8):2461-78. doi: 10.1007/s00520-015-2763-0. Epub 2015 May 15. Erratum In: Support Care Cancer. 2015 Sep;23(9):2853. doi: 10.1007/s00520-015-2815-5.. Sriram, Yennu [corrected to Yennurajalingam, Sriram].
PMID: 25975676BACKGROUNDRamsey-Goldman R, Rothrock N. Fatigue in systemic lupus erythematosus and rheumatoid arthritis. PM R. 2010 May;2(5):384-92. doi: 10.1016/j.pmrj.2010.03.026.
PMID: 20656619BACKGROUNDSharpe M, Wilks D. Fatigue. BMJ. 2002 Aug 31;325(7362):480-3. doi: 10.1136/bmj.325.7362.480. No abstract available.
PMID: 12202331BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miroslav Backonja, M.D.
National Center for Complementary and Integrative Health (NCCIH)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2019
First Posted
May 16, 2019
Study Start
September 13, 2019
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
May 1, 2026
Record last verified: 2026-04-29