An observational study in Inherited Metabolic Disorders, Undiagnosed Diseases and Batten's Disease, sponsored by National Human Genome Research Institute (NHGRI). Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by National Human Genome Research Institute (NHGRI) · Observational
Background:
In the U.S., about 53 million informal, unpaid caregivers provide care to a person who is ill, is disabled, or has age-related loss of function. These caregivers may be adult children, spouses, parents, or others. The stress of providing long-term care affects caregivers health and well-being. Researchers want to learn more about this stress and its effects.
Objective:
To learn how the caregiving process affects the health and well-being of caregivers over time.
Eligibility:
Adults aged 18 years and older who are caregivers for a person with a chronic medical condition and who have already given consent to take part in other study activities.
Design:
Participants will be put in different groups. They will complete some or all of the following tasks over 1 year. They may repeat these tasks once a year for up to 5 years.
Participants will fill out 2 online surveys. One will ask about their health and their caregiving experience. The other will ask them to list people in their social network and their care recipient s social network who give them support.
Participants will have a 2-part phone interview. It will be audio recorded. In part 1, they will be asked about the people they listed in the survey. In part 2, they will be asked about their caregiving experience and events in the care recipient s life.
Participants may fill out a weeklong diary every 3 months. It will ask about their daily social activities, well-being, and stress levels. It will also ask about their thoughts and feelings about caregiving.
Participants may give a blood sample each year they are in the study.
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Study Description: Caregivers will be invited to participate in surveys and interviews to assess their cognitions and emotions about caregiving, caregiving burden, and caregiving or support network systems during the life of the Care Recipient. The study will also include a bereavement component, in which families who have experienced the death of a Care Recipient may choose to participate. In addition, biomarkers may be evaluated in consenting individuals to assess genetic susceptibility to stress and stress-related dysregulations in the endocrine and immune systems.
Objectives: The primary objective of this study is to investigate the natural history of family caregiver stress over time, providing opportunity to understand the social, psychological, behavioral, and biological factors that characterize caregivers response to long-term caregiving during the life and after death of a Care Recipient with a chronic medical condition.
Endpoints: To assess the change over time in terms of social, psychological, behavioral, and biological factors associated with caregiving.
20 studies on the registry are indexed under Undiagnosed Diseases; 13 are open to participants now.
This study's planned enrollment of 2,800 is above the median of 400 across 17 observational studies indexed under Undiagnosed Diseases.
Browse Undiagnosed Diseases studies →National Human Genome Research Institute (NHGRI) is the lead sponsor of 203 studies on the registry; 33 are open to participants now.
Compared within Undiagnosed Diseases, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Referencing the enrollment numbers from the study of Inherited Diseases, Caregiving, and Social Networks (PI: Koehly, protocol #12HG0022), this longitudinal study will initially recruit from existing participants enrolled in #12HG0022. Family caregivers providing ongoing support for a chronically ill individual may be identified and informed about the Longitudinal Caregiving Study by an intramural NIH investigator involved in natural history protocols. Caregivers may also be recruited through other (nonNIH) clinicians, researchers, advocacy groups, online and traditional advertising, and ClinicalTrials.gov.
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To be eligible to participate in this study, an individual must meet all of the following criteria:
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from this study:
Staff of NHGRI are unable to participate in this study as a safeguard against the risk of ethical concerns. As per OHSRP SOP 404, NIH staff may be a vulnerable class of study subjects. Excluding staff of the Institute conducting the study assures there will not be any perceived or actual conflict of interest, pressure/coercion to participate among co-workers, subordinates, work unit-members, etc. As further noted in OHSRP SOP 404, exclusion further protects this class of subjects privacy and confidentiality; and protects the study s scientific integrity.
Persons with impaired neuro-sensory or decision-making ability (adults unable to provide consent) will not be enrolled in the study. Persons with impaired neuro-sensory or decision making ability would not be able to participate with independent responses to the various social behavioral measures we use in the study interview and survey. Learning information about these individuals through other people instead of themselves would introduce bias to this study.
Participants include individuals who are caregivers of an individual with a chronic medical condition, OR individuals who support caregivers of an individual with a chronic medical condition.
Participants include individuals who were caregivers of an individual with a chronic medical condition who has died, OR individuals who support the caregiver.
Natural History
Investigate the natural history of family caregiving to identify the social, psychological, behavioral, and biological mechanisms that determine possible long-term changes in health during the life and after death of a Care Recipient with a chronic medical condition.
Time frame: Annually / quarterly
Started Sep 2022 (actual). Primary completion is estimated for Dec 2030, 99 months after the start.
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