Patient-Centered Assessment of Symptoms and Outcomes
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03952624|
Recruitment Status : Enrolling by invitation
First Posted : May 16, 2019
Last Update Posted : August 16, 2019
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.
To understand the types of fatigue.
Adults 18 and older who have felt fatigue for more than a month, and non-fatigued adults
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.
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||672 participants|
|Official Title:||Patient-Centered Assessment of Symptoms and Outcomes|
|Estimated Study Start Date :||August 21, 2019|
|Estimated Primary Completion Date :||June 1, 2024|
|Estimated Study Completion Date :||July 1, 2024|
- The primary outcome will be the fatigue level using the Fatigue Numeric Rating Scale (FNS) score. [ Time Frame: Stage 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... [ Time Frame: All time points ]
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): NCT03952624
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Leorey N Saligan, C.R.N.P.||National Institute of Nursing Research (NINR)|