[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05007990":3,"trial-entities:NCT05007990":89,"trial-summary:NCT05007990":96},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":30,"primary_purpose":15,"phases":31,"enrollment_info":32,"interventions":35,"primary_outcomes":36,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":43,"healthy_volunteers":44,"eligibility_criteria":45,"std_ages":56,"locations":59,"central_contacts":76,"overall_officials":81,"references":84,"see_also_links":85},"NCT05007990","210020","Caregiving Networks Across Disease Context and the Life Course","Caregiving Networks Across Disease Context and the Life Course: A Comparative Longitudinal Study","RECRUITING","2030-12-31","2026-08-18","2026-08-20","2022-09-08","National Human Genome Research Institute (NHGRI)","NIH",null,"Background:\n\nIn 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.\n\nObjective:\n\nTo learn how the caregiving process affects the health and well-being of caregivers over time.\n\nEligibility:\n\nAdults 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.\n\nDesign:\n\nParticipants 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.\n\nParticipants 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.\n\nParticipants 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.\n\nParticipants 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.\n\nParticipants may give a blood sample each year they are in the study.\n\n...","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.\n\nObjectives: 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.\n\nEndpoints: To assess the change over time in terms of social, psychological, behavioral, and biological factors associated with caregiving.",[19,20,21,22,23],"Inherited Metabolic Disorders","Undiagnosed Diseases","Batten's Disease","Tay Sachs","Diabetes",[25,26,27,28,29],"Social Support","Rare Diseases","Natural History","Genetic Conditions","Family Network","OBSERVATIONAL",[],{"count":33,"type":34},2800,"ESTIMATED",[],[37],{"measure":27,"description":38,"timeFrame":39},"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 \u002F quarterly",[],"ALL","18 Years","100 Years",true,{"inclusion":46,"exclusion":52,"raw_text":55},[47,48,49,50,51],"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",[53,54],"Care Recipients (as defined in this protocol)","Staff of NHGRI","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Adults aged 18 years and older\n* 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\n* Ability to consent to research\n* 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.\n* Physically capable of participating in applicable assessments\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from this study:\n\n* Care Recipients (as defined in this protocol)\n* Staff of NHGRI\n\nStaff 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\u002Fcoercion 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.\n\nPersons 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.",[57,58],"ADULT","OLDER_ADULT",[60],{"facility":61,"status":8,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":73},"National Institutes of Health Clinical Center","Bethesda","Maryland","20892","United States",[67],{"name":68,"role":69,"phone":70,"phoneExt":71,"email":72},"For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)","CONTACT","800-411-1222","TTY dial 711","ccopr@nih.gov",{"lat":74,"lon":75},38.98067,-77.10026,[77],{"name":78,"role":69,"phone":79,"email":80},"Laura M Koehly, Ph.D.","(301) 451-3999","koehlyl@mail.nih.gov",[82],{"name":78,"affiliation":13,"role":83},"PRINCIPAL_INVESTIGATOR",[],[86],{"label":87,"url":88},"NIH Clinical Center Detailed Web Page","https:\u002F\u002Fclinicalstudies.info.nih.gov\u002Fcgi\u002Fdetail.cgi?A_2021-HG-0020.html",{"nct_id":4,"conditions":90,"biomarkers":95},[91,92,19,93,94,22,20],"Diabetes Mellitus","Genetic Disorder","Neuronal Ceroid Lipofuscinosis Type 3","Rare Disorder",[],{"nct_id":4,"found":44,"summary":97,"prompt_version":107},{"design":98,"status":99,"heading":100,"summary":101,"follow_up":102,"word_count":103,"commitments":104,"compensation":105,"drugs_mentioned":106},"This is an observational study planning to include 2800 participants. Participants will be put into different groups.","completed","Understanding Caregiver Health and Well-being","This observational study wants to understand how being a caregiver affects your health and well-being over time. Researchers are looking at the experiences of adults aged 18 and older who care for someone with a chronic medical condition, such as inherited metabolic disorders, undiagnosed diseases, Batten's disease, Tay Sachs, or diabetes. The study will follow caregivers annually or quarterly to see how social, psychological, behavioral, and biological factors change while they are providing care and after the person they care for has passed away. This study is not testing a new treatment, but rather observing the natural course of caregiver stress. The goal is to learn more about the challenges caregivers face.","Your health and well-being will be assessed annually or quarterly.",112,"You will be invited to complete surveys and interviews to share your thoughts and feelings about caregiving, the burden of care, and your support networks over one year.","Not stated in the trial record.",[],"v2"]