Multicenter Prospective Cohort of Informal Caregivers in Burgundy-Franche-Comté. ICE Cohort (Informal Caregivers of Elderly)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- (Observational study) Changes in social support of patients' caregivers using the SSQ6 questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •previously diagnosed with another targeted disease and/or living in retirement home could not be included
- •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,
- •Exclusion Criteria:
- •to be under guardianship, curatorship or under the protection of justice
结局指标
主要结局
(Observational study) Changes in social support of patients' caregivers using the SSQ6 questionnaire
时间窗: 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.
(Interventional Study) Comparison of caregivers' HRQoL according to the allocated intervention by randomization based on summaries score the MOS SF36
时间窗: 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 cancer patients' caregivers using the CarGoQoL questionnaire
时间窗: 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
时间窗: 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
时间窗: 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 HRQoL of patients' caregivers using the MOS SF36 questionnaire
时间窗: 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 burden of patients' caregivers using the Zarit burden inventory
时间窗: 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
次要结局
- (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)
- (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)
- (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)
- (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)
- (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)
- (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)
- (Interventional Study) Comparison of caregivers' HRQoL according to the intervention allocated by randomization based on summaries score the MOS SF36(Two years after randomization)
- (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)
- (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)
- (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)