Patient-Centered Assessment of Symptoms and Outcomes

April 18, 2024 updated by: National Institute of Nursing Research (NINR)

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.

...

Study Overview

Status

Recruiting

Conditions

Detailed Description

Purpose: The purpose of this study is to allow for deep and broad phenotyping of persons with clinically-meaningful fatiguing symptoms, regardless of physiologic or pathologic condition. This protocol will enable the National Institute of Nursing Research (NINR) investigators to describe the clinical characteristics of persons reporting clinically-meaningful fatigue and collect clinical and scientific data for the purpose of making comprehensive phenotypic descriptions. These phenotypic descriptions will be used to explore the heterogeneity of fatiguing symptoms to clarify the nature of different fatigue phenotypes and their biologic correlates.

The specific goals of this protocol are the following:

To characterize and phenotype individuals with clinically-meaningful fatigue.

To explore the heterogeneity of fatiguing conditions to define specific fatigue dimensions.

To generate hypotheses of the possible mechanism of each fatigue dimension.

Study Population: The study population will consist of up to 672 persons with or without clinically-meaningful fatigue. Approximately 20 will be enrolled in the technical development substudy to refine the neuroimaging techniques used in this study. This protocol is open to anyone of any ethnicity, gender, or nationality.

Design: The protocol is designed as an exploratory multi-stage study. Upon receiving inquiry from a potential participant, a phone screening using an eligibility questionnaire and an in-person NIH outpatient screening visit will be conducted. If a treatable medical condition is identified during the screening that directly contributes to the fatigue experience, then the participant will not proceed in the study but will be asked to see their care provider for evaluation and/or management. Those who are under a known treatment (e.g., chemotherapy, antivirals) for a clinical condition or those without a clear clinical explanation for their fatigue will be invited to participate in Stage 1 of the study. Stage 1 is the fatigue assessment stage and includes completion of self-report questionnaires and performance tasks. Stage 2 will include additional clinical and scientific assessments to allow for deeper understanding of the fatigue phenotype. Before study termination, participants may be referred to appropriate NIH CC services for management recommendations. Participants who complete the study may be re-contacted about other available fatigue intervention studies.

Multi-Stage Study Design

Stage 1 - Fatigue Assessment

Stage 2 - Fatigue Dimension Phenotyping Evaluation

Outcome Measures: The study will use a wide variety of measurement tools for phenotyping purposes. These include: vital signs, medical history, physical exam, blood draw, medical record review, clinical interviews, patient reported outcome measurements, physical, cognitive, affective, and behavioral measurements, structural and functional imaging assessments, nutritional assessment, clinical and research laboratory measurements, and electrocardiogram.

In summary, the NINR Patient-Centered Assessment of Symptoms and Outcomes (P-CASO) protocol will enable investigators to obtain detailed clinical descriptions and to collect phenotyping measurements from research participants who report clinically-meaningful fatigue.

The study will allow NINR investigators to perform descriptive research on fatigue for hypothesis generation.

Study Type

Observational

Enrollment (Estimated)

672

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Recruiting
        • National Institutes of Health Clinical Center
        • Contact:
          • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
          • Phone Number: TTY8664111010 800-411-1222
          • Email: prpl@cc.nih.gov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

  • 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.

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 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 (greater than or equal to 5 drinks/day and greater than or equal to 15 drinks/week for men, greater than or equal to 4 drinks per day and greater than or equal to 8 drinks per 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.

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.

  • EEfRT and Stroop Test

    • Severe essential hand tremor or severe hand pain (e.g., severe arthritis or severe carpel tunnel) that makes it difficult to perform rapid keyboard presses will be an exclusion from the EEfRT and 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.

  • Tilt Table Test

    --Beta blocker medications.

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Control
FNS <= 3
Fatigued
FNS >= 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue Level
Time Frame: Stage 1 and Stage 2
The primary outcome will be the fatigue level using the Fatigue Numeric Rating Scale (FNS) score.
Stage 1 and Stage 2

Secondary Outcome Measures

Outcome Measure
Time Frame
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
All time points

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Leorey N Saligan, C.R.N.P., National Institute of Nursing Research (NINR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2019

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

May 15, 2019

First Submitted That Met QC Criteria

May 15, 2019

First Posted (Actual)

May 16, 2019

Study Record Updates

Last Update Posted (Estimated)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 190098
  • 19-NR-0098

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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