Caregiving Networks Across Disease Context and the Life Course

NCT05007990 | Recruiting

• 2 other identifiers: 21002021-HG-0020
• Study Type: observational
• Target: 2,800
• Locations: 1 country
• Sites: 1

Brief Summary

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. ...

Conditions

Inherited Metabolic Disorders; Undiagnosed Diseases; Batten's Disease; Tay Sachs; Diabetes

Keywords

Social Support; Rare Diseases; Natural History; Genetic Conditions; Family Network

Outcome Measures

Primary Outcomes (1)

• 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.

  Annually / quarterly

Study Arms (2)

Active

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.

Bereaved

Participants include individuals who were caregivers of an individual with a chronic medical condition who has died, OR individuals who support the caregiver.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• To be eligible to participate in this study, an individual must meet all of the following criteria:
• Adults aged 18 years and older
• If the Care Recipient is living, they must self-identify as a primary caregiver to the Care Recipient (individual with a chronic medical condition), OR if the Care Recipient is deceased, they must self-identify as having been a primary caregiver to the now-deceased Care Recipient, OR they must otherwise be identified (i.e., referred) by a participant as a part of the caregiving network
• Ability to consent to research
• Fluency in English will be needed to complete interview as well as to read, comprehend surveys and consent forms, as appropriate validated measures in other languages are not readily available.
• Physically capable of participating in applicable assessments

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from this study:
• Care Recipients (as defined in this protocol)
• Staff of NHGRI
• 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.

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Undiagnosed Diseases; Neuronal Ceroid-Lipofuscinoses; Diabetes Mellitus; Rare Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipidoses; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases

Study Officials

• Laura M Koehly, Ph.D.

  National Human Genome Research Institute (NHGRI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura M Koehly, Ph.D.

CONTACT

(301) 451-3999; koehlyl@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2021
• First Posted: August 17, 2021
• Study Start: September 8, 2022
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 30, 2026

Record last verified: 2026-03-26

Locations

US (1)