Multicenter Prospective Cohort of Informal Caregivers in Burgundy and Franche-Comté "ICE"

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Support provided by social worker Behavioral
    Intervention Desc: Caregivers randomized in intervention arm will receive an information booklet (which informs about existing structures and actions) and will receive support provided by a social worker schedule every 6 months during two years. The support duration will be one hour and will be defined as two parts: administration of the LASA questionnaire, and a standardized semi directive interview to assess needs.
    ARM 1: Kind: Experimental
    Label: Interventional arm
    Description: 'Support provided by social worker'
  • Information booklet receipt Other
    Intervention Desc: Caregivers will only receive an information booklet (which informs about existing structures and actions)
    ARM 1: Kind: Experimental
    Label: Non-interventional arm
    Description: 'Information booklet receipt'
    ARM 2: Kind: Experimental
    Label: Interventional arm
    Description: 'Support provided by social worker'

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary (Interventional Study) Comparison of caregivers' HRQoL according to the allocated intervention by randomization based on summaries score the MOS SF36 One year after randomization No
Primary (Observational study) Changes in HRQoL of patients' caregivers using the MOS SF36 questionnaire At 1, 3, 6, 9, 12, 15,18, 21, 24, 30, 36, 42, 48, 54 and 60 months post-randomization No
Primary (Observational study) Changes in HRQoL of cancer patients' caregivers using the CarGoQoL questionnaire At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization No
Primary (Observational study) Changes in the coping strategies of patients' caregivers using the Borteyrou, Rascle and Truchot Questionnaire At 1, 6, 12, 24, 36, 48 and 60 months post-randomization No
Primary (Observational study) Changes in feelings of anxiety and depression of patients' caregivers according to the HADs questionnaire At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization No
Primary (Observational study) Changes in social support of patients' caregivers using the SSQ6 questionnaire At 1, 6, 12, 24, 36, 48 and 60 months post-randomization No
Primary (Observational study) Changes in burden of patients' caregivers using the Zarit burden inventory At 1, 6, 12, 24, 36, 48 and 60 months post-randomization No
Secondary (Interventional Study) Comparison of caregivers' HRQoL according to the intervention allocated by randomization based on summaries score the MOS SF36 Two years after randomization No
Secondary (Interventional Study) Changes in HRQoL of patients' caregivers according to the allocated intervention using the MOS SF36 questionnaire At 1, 3, 6, 9, 12, 15,18, 21, 24, 30, 36, 42, 48, 54 and 60 months post-randomization No
Secondary (Interventional Study) Changes in HRQoL of cancer patients' caregivers according to the allocated intervention using the CarGoQol questionnaire At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization No
Secondary (Interventionnal Study) Changes in the coping strategies of patients' caregivers according to the allocated intervention using the Borteyrou, Rascle and Truchot Questionnaire At 1, 6, 12, 24, 36, 48 and 60 months post-randomization No
Secondary (Interventional Study) Changes in feelings of anxiety and depression of patients' caregivers according to the allocated intervention using the HADs Questionnaire At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48,54 and 60 months post-randomization No
Secondary (Interventional Study) Changes in social supports of patients' caregivers according to the allocated intervention using the SSQ6 questionnaire At 1, 6, 12, 24, 36, 48 and 60 months post-randomization No
Secondary (Interventional Study) Changes in burden of patients' caregivers according to the allocated intervention using the Zarit burden inventory At 1, 6, 12, 24, 36, 48 and 60 months post-randomization No
Secondary (Interventional study) Efficiency of the intervention of a social worker for caregivers using a cost-utility analysis At 1, 3, 6,9,12,15,18 and 24 months post-randomization No
Secondary (Observational study) Changes in the caregivers/patients' relationship using a qualitative approach (semi-structure interview) At 1,6,12,18,24,30,36,42,48,54 and 60 months post randomization No
Secondary (Observational study) Changes in the role of caregiver due to a situation generating a rupture (entry into an institution or death, disease remission) using a qualitative approach (semi-structure interview) At 1,6,12,18,24,30,36,42,48,54 and 60 months post randomization No

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