{"type":"trials","record":{"id":42082,"source_id":"clinicaltrials-gov","external_id":"NCT02626377","title":"Multicenter Prospective Cohort of Informal Caregivers in Burgundy and Franche-Comté","brief_summary":"Medical progress and modification of lifestyles have prolonged life expectancy, despite the development of chronic diseases. The support and care are often provided by a network of informal caregivers composed of family, friends, and neighbors. They became essential to help maintening the elderly persons to live at home. It has been demonstrated that the importance and the diversity of informal tasks may jeopardize their own physical, mental and social well-being. The aim of the Informal Carers of Elderly Cohort is to define, through a longitudinal study of their life course, the profiles of caregivers of patients with a diagnosis of one of the following diseases: cancer (breast, prostate, colon-rectum), neuro-degenerative diseases (Parkinson's disease, Alzheimer's and similar diseases), neuro-vascular diseases (Cerebrovascular Accident (CVA)), Age-related Macular Degeneration(AMD) and heart disease (heart failure), aged ≥ 60 years old and living in Burgundy or Franche-Comte. By following the different phases of the caregiving relationship from the announcement of the diagnosis, it will be possible to assess the quality of life of caregivers and evaluate the implementation of a pragmatic social action to help informal caregivers through a randomized intervention trial nested in the cohort. Thanks to an analytical and longitudinal definition of the profiles of informal caregivers, this study could gather precise information on their life courses and their health trajectory by identifying the consequences associated with the concept of their role of aid in care. In addition, the randomized intervention trial will explore the efficacy, in terms of quality of life, and efficiency of a social action to support the caregivers. These data will allow to identify strategies that could be used to improve the existing sources of aid and to propose new approaches to help caregivers. This study will provide the opportunity to identify the most relevant means of support and to give an impulse for new healthcare policies.","overall_status":"Terminated","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Centre Hospitalier Universitaire de Besancon","enrollment":186,"countries":["France"],"start_date":"2015-10-01","completion_date":"2019-05-01","last_update_date":"2023-10-23","source_url":"https://clinicaltrials.gov/study/NCT02626377","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Terminated. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:30.378222+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":"ICE","age_range":"60 Years","comparator":null,"organization":"Centre Hospitalier Universitaire de Besancon","interventions":["Support provided by social worker","Information booklet receipt"],"registry_source":"ClinicalTrials.gov","outcome_measures":["(Interventional Study) Comparison of caregivers' HRQoL according to the allocated intervention by randomization based o…","(Observational study) Changes in HRQoL of patients' caregivers using the MOS SF36 questionnaire — At 1, 3, 6, 9, 12, 15…","(Observational study) Changes in HRQoL of cancer patients' caregivers using the CarGoQoL questionnaire — At 1, 3, 6, 9,…","(Observational study) Changes in the coping strategies of patients' caregivers using the Borteyrou, Rascle and Truchot…","(Observational study) Changes in feelings of anxiety and depression of patients' caregivers according to the HADs quest…","(Observational study) Changes in social support of patients' caregivers using the SSQ6 questionnaire — At 1, 6, 12, 24,…","(Observational study) Changes in burden of patients' caregivers using the Zarit burden inventory — At 1, 6, 12, 24, 36,…","(Interventional Study) Comparison of caregivers' HRQoL according to the intervention allocated by randomization based o…","(Interventional Study) Changes in HRQoL of patients' caregivers according to the allocated intervention using the MOS S…","(Interventional Study) Changes in HRQoL of cancer patients' caregivers according to the allocated intervention using th…","(Interventionnal Study) Changes in the coping strategies of patients' caregivers according to the allocated interventio…","(Interventional Study) Changes in feelings of anxiety and depression of patients' caregivers according to the allocated…","(Interventional Study) Changes in social supports of patients' caregivers according to the allocated intervention using…","(Interventional Study) Changes in burden of patients' caregivers according to the allocated intervention using the Zari…","(Interventional study) Efficiency of the intervention of a social worker for caregivers using a cost-utility analysis —…","(Observational study) Changes in the caregivers/patients' relationship using a qualitative approach (semi-structure int…","(Observational study) Changes in the role of caregiver due to a situation generating a rupture (entry into an instituti…"],"design_description":"RANDOMIZED · PARALLEL · OTHER · NONE","source_has_results":false},"controlled_terms":["Breast Cancer","Colorectal Cancer","Prostate Cancer","Alzheimer Disease","Age-related Macular Degeneration","Parkinson Disease","Cardiac Disease","Ischemic Stroke","Hemorrhagic Stroke","Support provided by social worker","Information booklet receipt"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Abstract contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct02626377","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2015-10-01 to 2019-05-01","comparator":null,"confidence":"structured-source","population":"ALL · 60 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:20:47.917Z","intervention":["Support provided by social worker","Information booklet receipt"],"participants":186,"study_design":"RANDOMIZED · PARALLEL · OTHER · NONE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["(Interventional Study) Comparison of caregivers' HRQoL according to the allocated intervention by randomization based o…","(Observational study) Changes in HRQoL of patients' caregivers using the MOS SF36 questionnaire — At 1, 3, 6, 9, 12, 15…","(Observational study) Changes in HRQoL of cancer patients' caregivers using the CarGoQoL questionnaire — At 1, 3, 6, 9,…","(Observational study) Changes in the coping strategies of patients' caregivers using the Borteyrou, Rascle and Truchot…","(Observational study) Changes in feelings of anxiety and depression of patients' caregivers according to the HADs quest…","(Observational study) Changes in social support of patients' caregivers using the SSQ6 questionnaire — At 1, 6, 12, 24,…","(Observational study) Changes in burden of patients' caregivers using the Zarit burden inventory — At 1, 6, 12, 24, 36,…","(Interventional Study) Comparison of caregivers' HRQoL according to the intervention allocated by randomization based o…","(Interventional Study) Changes in HRQoL of patients' caregivers according to the allocated intervention using the MOS S…","(Interventional Study) Changes in HRQoL of cancer patients' caregivers according to the allocated intervention using th…","(Interventionnal Study) Changes in the coping strategies of patients' caregivers according to the allocated interventio…","(Interventional Study) Changes in feelings of anxiety and depression of patients' caregivers according to the allocated…","(Interventional Study) Changes in social supports of patients' caregivers according to the allocated intervention using…","(Interventional Study) Changes in burden of patients' caregivers according to the allocated intervention using the Zari…","(Interventional study) Efficiency of the intervention of a social worker for caregivers using a cost-utility analysis —…","(Observational study) Changes in the caregivers/patients' relationship using a qualitative approach (semi-structure int…","(Observational study) Changes in the role of caregiver due to a situation generating a rupture (entry into an instituti…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"vision-aging","is_published":true,"match_reasons":["Abstract contains controlled term: age-related macular degeneration.","Source terminology contains: age-related macular degeneration.","Abstract supplies longevity context: age-related, elderly.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["abstract","controlled terminology","abstract context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Vision ageing","slug":"vision-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/42082","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}