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Patient-Centered Assessment of Symptoms and Outcomes

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ClinicalTrials.gov Identifier: NCT03952624
Recruitment Status : Enrolling by invitation
First Posted : May 16, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )

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.


Condition or disease
Fatigue

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 672 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Group/Cohort
1
Fatigued subjects
2
Non-fatigued subjects



Primary Outcome Measures :
  1. The primary outcome will be the fatigue level using the Fatigue Numeric Rating Scale (FNS) score. [ Time Frame: Stage 1 ]

Secondary Outcome Measures :
  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 ]


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:   Non-Probability Sample
Study Population
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.
Criteria
  • INCLUSION CRITERIA:

All Participants

  • Adult participants aged greater than or equal to 18 years at the time of enrollment;
  • Able to provide written informed consent;
  • Willing and able to complete study procedures;

    • Must be right-handed to participate in the Functional Magnetic Resonance Imaging (fMRI) technical development sub-study.;

Fatigued Participants

-In addition to the above, must experience fatigue for more than a month.

EXCLUSION CRITERIA:

Exclusion from study entry:

  • 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);
  • Current substance use disorder within the last five years as diagnosed on the Structured Clinical Interview for DSM-5 (SCID-5) or positive urine toxicology results at enrollment and before Stage 2. Prior marijuana use within the past five years will not be an exclusion;
  • Categorized as a high-risk drinker ( (Bullet)5 drinks/day for men, (Bullet)4 drinks per day for women). ( Dietary Guidelines for Americans 2015-2020, U.S. Department of Health and Human Services and U.S. Department of Agriculture).
  • NINR employees or subordinates, relatives, and/or co-workers of NINR employees/staff or study investigators.

Exclusion from Stage 1 Tests

  • EEfRT

    --Have severe hand pain that makes it difficult to perform rapid keyboard presses (e.g., severe arthritis or severe carpel tunnel).

  • Stroop Test

    • Color-blindness, verified by scoring greater than or equal to 14 on the Ishihara card test, will exclude a participant from taking the Stroop test. The Ishihara card test will be administered only if the participant states he or she is color-blind.

Exclusion from Stage 2 Tests:

  • 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;
    • Unable to lie comfortably on back for up to 4 hours;
    • Left-handed;
    • Pregnant or lactating.
  • Stroop Test

    --Color-blindness, verified by scoring greater than or equal to 14 on the Ishihara card test, will exclude a participant from taking the Stroop test. The Ishihara card test will be administered only if the participant states he or she is color-blind.

  • CPET

    • Any neuromuscular conditions (e.g., multiple sclerosis, Parkinson s disease) with significant mobility impairment that prohibits treadmill or bike performance, or any medical condition (e.g., congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease [COPD], severe osteoarthritis and poorly controlled asthma) that would make it risky for the participant to exercise (e.g., exercise-induced angina and asthma), will exclude a participant from the CPET;
    • Pregnant or 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): NCT03952624


Locations
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United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Leorey N Saligan, C.R.N.P. National Institute of Nursing Research (NINR)

Additional Information:
Publications:
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Responsible Party: National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier: NCT03952624     History of Changes
Other Study ID Numbers: 190098
19-NR-0098
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: July 26, 2019

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) ):
Symptom Biology
Symptom Phenotyping
Fatigue

Additional relevant MeSH terms:
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Fatigue
Signs and Symptoms