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Trials
Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Evaluation of efficacy and efficiency of a pragmatic intervention by a social worker to support informal caregivers of elderly patients (The ICE Study): study protocol for a randomized controlled trial

Authors: Astrid Pozet, Catherine Lejeune, Magalie Bonnet, Sandrine Dabakuyo, Michèle Dion, Philippe Fagnoni, Maryse Gaimard, Geneviève Imbert, Virginie Nerich, Audrey Foubert, Morgane Chotard, Marie Bonin, Amélie Anota, Franck Bonnetain

Published in: Trials | Issue 1/2016

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Abstract

Background

Medical progress and the lifestyle modification have prolonged life expectancy, despite the development of chronic diseases. Support and care for older subjects are often provided by a network of informal caregivers composed of family, friends and neighbors, who are essential in helping older persons to continue living at home. It has been shown that the extent and diversity of informal tasks may jeopardize the physical, mental and social wellbeing of caregivers.

Methods/design

The aim of the Informal Carers of Elderly cohort is to define, through a longitudinal study, profiles of caregivers of older patients with a diagnosis of one of the following diseases: cancer (breast, prostate, colorectal), neurodegenerative diseases (Parkinson’s disease, Alzheimer’s disease and similar diseases), neurovascular diseases (stroke), sensory diseases (age-related macular degeneration (AMD)) and heart disease (heart failure). Patients must be at least 60 years old and living in the region of Burgundy-Franche-Comte (France). 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, coping strategies, levels of anxiety and depression, social support and the extent of their burden. We will also evaluate the efficacy and efficiency of the implementation of a pragmatic intervention by a social worker to help informal caregivers, through a randomized interventional trial nested in the cohort. Qualitative approaches aimed at studying the caregiver/patient relationship, and situations leading to breakdown of the caregiver relationship will be also undertaken.

Discussion

Through an analytical and longitudinal definition of profiles of informal caregivers, this study will gather detailed information on their life courses and their health trajectory by identifying consequences associated with the concept of their role as carers. In addition, the randomized interventional trial will explore the relevance of the implementation of a supportive intervention by a social worker to help caregivers. These data will help 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 adapted to caregivers, and provide an impulse for new health care policies.

Trial registration

ClinicalTrials.gov Identifier: NCT02626377. Retrospectively registered on 9 December 2015. Protocol date/version: 23 October 2014/version 2.
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Metadata
Title
Evaluation of efficacy and efficiency of a pragmatic intervention by a social worker to support informal caregivers of elderly patients (The ICE Study): study protocol for a randomized controlled trial
Authors
Astrid Pozet
Catherine Lejeune
Magalie Bonnet
Sandrine Dabakuyo
Michèle Dion
Philippe Fagnoni
Maryse Gaimard
Geneviève Imbert
Virginie Nerich
Audrey Foubert
Morgane Chotard
Marie Bonin
Amélie Anota
Franck Bonnetain
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1622-8

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