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

Multicenter Prospective Cohort of Informal Caregivers in Burgundy-Franche-Comté. ICE Cohort (Informal Caregivers of Elderly)

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02626377

Acronym

ICE

Enrollment

186

Registered

2015-12-10

Start date

2015-10-31

Completion date

2019-05-31

Last updated

2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Informal caregivers, Elderly, Quality of life, Cost effectiveness, Cohort study, Randomized study

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.

Interventions

BEHAVIORALSupport 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.

OTHERInformation booklet receipt

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Inclusion criteria

Patient : 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).

Exclusion criteria

* previously diagnosed with another targeted disease and/or living in retirement home could not be included Caregiver Inclusion Criteria: * 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,

Design outcomes

Primary

Measure	Time frame	Description
(Interventional Study) Comparison of caregivers' HRQoL according to the allocated intervention by randomization based on summaries score the MOS SF36	One year after randomization	The main objective of the randomized study is to compare the Health Related Quality of Life based on summaries score the MOS SF36 one year after randomization according to the allocated intervention.
(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	The main objective of the observational study is to define the longitudinal profiles of patient's caregivers according to the evaluation of their HRQoL using the MOS SF36 questionnaire
(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	the aim of the observational study is to define the longitudinal profiles of cancer patient's caregivers according to the evaluation of their HRQoL using the CarGoQoL questionnaire
(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	The aim of the observational study is to define the longitudinal profiles of patient's caregivers according to the evaluation of their coping strategies using the Borteyrou, Rascle and Truchot Questionnaire.
(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	The aim of the observational study is to define the longitudinal profiles of patient's caregivers according to the evaluation of their anxiety and depression according to the HADs questionnaire.
(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	The aim of the observational study is to define the longitudinal profiles of patient's caregivers according to the evaluation of their social support using the SSQ6 questionnaire.
(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	The aim of the observational study is to define the longitudinal profiles of patient's caregivers according to the evaluation burden using the Zarit burden inventory

Secondary

Measure	Time frame	Description
(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	The efficiency of the intervention of a social worker for caregivers will be assessed using a cost-utility analysis, aiming at comparing in terms of costs and utility the intervention versus the absence of intervention of a social worker
(Interventional Study) Comparison of caregivers' HRQoL according to the intervention allocated by randomization based on summaries score the MOS SF36	Two years after randomization	To compare the Health Related Quality of Life based on summaries score the MOS SF36 two years after randomization according to the allocated intervention.
(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	to study the situations generating a rupture in their role of caregiver (entry into an institution or death, disease remission) using a qualitative approach (semi-structure interview)
(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	to evaluate the caregivers/patients' relationship and the changes of the relationship using a qualitative approach (semi-structure interview), to describe the specificity of the care and of the help from people carrying diseases with behavioral disorders (Alzheimer-type dementia in particular)
(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	To compare longitudinally all dimensions of HRQoL using the MOS SF36 questionnaire according to the allocated intervention.
(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	To compare longitudinally the HRQoL of cancer patients' caregivers, according to the allocated intervention, using the CarGoQol questionnaire.
(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	To compare longitudinally the coping strategies of patients' caregivers, according to the allocated intervention, using the Borteyrou, Rascle and Truchot Questionnaire.
(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	To compare longitudinally the feelings of anxiety and depression of patients' caregivers, according to the allocated intervention, using the HADs Questionnaire.
(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	To compare longitudinally the social support of patients' caregivers, according to the allocated intervention, using the SSQ6 questionnaire.
(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	To compare longitudinally the burden of patients' caregivers, according to the allocated intervention, using the Zarit burden inventory.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026