Ignite Creation Date:
2024-05-06 @ 1:10 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03952624
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2019-05-15
Brief Title:
Patient-Centered Assessment of Symptoms and Outcomes
Sponsor:
National Institute of Nursing Research NINR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Patient-Centered Assessment of Symptoms and Outcomes
Status:
RECRUITING
Status Verified Date:
2024-09-19
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 andor management Those who are under a known treatment eg 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
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 andor management Those who are under a known treatment eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 19-NR-0098 | None | None | None |