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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2019-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Colorectal Cancer Prostate Cancer Alzheimer Disease Age-related Macular Degeneration Parkinson Disease Cardiac Disease Ischemic Stroke Hemorrhagic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Interventional arm

'Support provided by social worker'

Group Type EXPERIMENTAL

Support provided by social worker

Intervention Type BEHAVIORAL

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.

Information booklet receipt

Intervention Type OTHER

Caregivers will only receive an information booklet (which informs about existing structures and actions)

Non-interventional arm

'Information booklet receipt'

Group Type OTHER

Information booklet receipt

Intervention Type OTHER

Caregivers will only receive an information booklet (which informs about existing structures and actions)

Interventions

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Support provided by social worker

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.

Intervention Type BEHAVIORAL

Information booklet receipt

Caregivers will only receive an information booklet (which informs about existing structures and actions)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* To be able to identify a principal caregiver via a specific questionnaire (if the patient is unable to identify himself his caregiver due to the disease, a self-designation form as a principal caregiver will be allow and propose)
* to accept to complete the questionnaire to designate the principal caregiver;
* To live in either Burgundy-Franche-Comte county;
* have been recently diagnosed at hospital or in private-sector for the following diseases: Local or metastatic cancer diagnosed less than 6 month (breast cancer-hormone sensitive- in first line chemotherapy treatment, hormone-sensitive prostate cancer or in metastatic recurrence after 3 years of remission, considered as a new case, colorectal cancer in first line chemotherapy treatment), a neuro-degenerative disease (Parkinson disease diagnosed less than 7 years, Alzheimer disease and similar diseases diagnosed less than 12 months and /or with a Mini Mental State Examination (MMSE)\<24 and \>10 (performed less than 3 mois)), Age-related Macular Degeneration,( geographic atrophy or neovascular, diagnosed less than 12 month with an acuity range between 2 and 6/10e, be at least 65 years old and have received less than 3 sessions of intravitreal injections (IVT)), cardiac disease (heart failure diagnosed less than 3 months), neuro-vascular disease (ischemic or hemorrhagic stroke with clinical evidence of post stroke lesions upper than 24 hours, diagnosed less than 6 months and with a Rankin's score inferior or equal to 2).

* to be a member of the patient's social environment (family, friend and neighbor);
* to be identify by the patient as the "principal caregiver" based on the designation questionnaire or to have complete the self-designation form as a principal caregiver;
* ≥ 18 years old;
* not be an employee of a healthcare organization;
* living in Burgundy-Franche-Comte;
* to be able to complete questionnaires,

Exclusion Criteria

* previously diagnosed with another targeted disease and/or living in retirement home could not be included

Caregiver

\- to be under guardianship, curatorship or under the protection of justice

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No