Caregiving Networks Across Disease Context and the Life Course

Caregiving Networks Across Disease Context and the Life Course: A Comparative Longitudinal Study

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 Overview

• Status: Recruiting
• Conditions: Diabetes; Undiagnosed Diseases; Inherited Metabolic Disorders; Batten's Disease; Tay Sachs

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 2250

Contacts and Locations

• Study Contact: Name: Laura M. Koehly, Ph.D.; Phone Number: (301) 451-3999; Email: koehlyl@mail.nih.gov

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: TTY dial 711 800-411-1222; Email: ccopr@nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

• INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

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

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Family-Based
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Human Genome Research Institute (NHGRI)
• Investigators: Principal Investigator: Laura M. Koehly, Ph.D., National Human Genome Research Institute (NHGRI)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2022
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: August 14, 2021
• First Submitted That Met QC Criteria: August 14, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Estimated): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 11, 2024
• Last Verified: May 10, 2024

More Information

Terms related to this study

• Keywords: Natural History; Rare Diseases; Social Support; Family Network; Genetic Conditions
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Disease Attributes; Genetic Diseases, Inborn; Neurodegenerative Diseases; Metabolism, Inborn Errors; Heredodegenerative Disorders, Nervous System; Lipid Metabolism Disorders; Lipidoses; Lipid Metabolism, Inborn Errors; Metabolic Diseases; Neuronal Ceroid-Lipofuscinoses; Undiagnosed Diseases
• Other Study ID Numbers: 210020; 21-HG-0020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No