E-health and People Living With Major Neurocognitive Disorder: A Study of the Effects of the CARE© and ESOGER© Applications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Response Rate to CARE© questionnaires
研究概览
简要总结
The care pathways of people living with major neurocognitive disorders (MNCD) are often inadequate due to poor access to resources, long delays, and resources that are poorly adapted to expectations and needs. This situation was exacerbated during the coronavirus disease (COVID-19) pandemic due to the reduction of available resources and care provider burnout. People living with MNCD are at risk of becoming more fragile, which can lead to emergency room visits and hospitalizations, and significantly alter the quality of life of the dyad (family caregiver and the person being cared for). Intervening earlier in the care pathway would make it possible to avoid the aggravation of pathologies associated with MNCD and hospitalizations.
The reorganization of activities imposed by the social distancing measures due to the pandemic has shown that e-health is a solution to maintain access to resources for people living with chronic conditions such as MNCD. We have been working since the beginning of the pandemic on the development of two complementary health applications for seniors and their dyads: the self-assessment questionnaire on frailty (CARE©) and the Evaluation et orientation SOcio-GÉRiatrique (ESOGER©) questionnaire :
- CARE© is made by the dyad, allowing to identify a state of frailty and the risks related to it. It relies on the active participation of the user and is deployed in the form of an application.
- ESOGER© is a standardized hetero-questionnaire filled out remotely, during a telephone call, by a community organization worker with the user and/or his/her caregiver. It is a tool for first contact, listening and accompanying a user, which makes it possible to determine whether the needs for care and services are being met, to prioritize the needs, to trigger the implementation of care and services, and to make the link with the organizations providing care and services.
The objectives of this study are to examine the effects of CARE© combined with ESOGER© on the state of physical and mental frailty, loss of autonomy, quality of life, and consumption of health services and care resources in people living with a major neurocognitive disorder (MNCD).
详细描述
This study includes two phases. The first phase is a feasibility study that aims to assess the behavior of users in relation to digital tools. Phase 2 will focus on evaluating the effects of the recommendations.
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
- Single (Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 65 years old or older.
- •Have been previously diagnosed of MNCD (major neurocognitive disorder).
- •Have a caregiver.
- •Live in Montreal.
- •Live at home or in a residence for seniors (RPA) in a non-medicalized area.
- •Have an internet connection.
- •Have a computer, or a touch pad or a smart phone.
- •Understand French or English orally and in writing. The speakers are French and/or English speaking, and the questionnaires are only available in these 2 languages.
排除标准
- •Participate in a concurrent investigational clinical study, to avoid interference with our study
- •Live in a Residential and Long-Term Care Center (CHSDL) or in a medical sector in an RPA
研究组 & 干预措施
Intervention group
Phase 1
- Participants will assess their health status, at home, at recruitment (M0) and at 3 months (M3) with CARE© with the help of their family caregivers.
- The principal investigator or a representative will contact them by phone within 5 days of the CARE© assessment to complete ESOGER.
Phase 2
- Participants will assess their health status, at home, at recruitment (M0), at 3 months (M3), and at 6 months (M6) on the CARE© application with the help of their family caregivers. An additional assessment will take place over the phone by the principal investigator or one of his representatives.
- If their health status is considered fragile, then individuals will be contacted by phone by the PI or one of his representatives to complete the ESOGER© questionnaire (at M0, M3 and M6).
干预措施: Recommendations and reorientation towards healthcare resources (Other)
Control group
Phase 1
- Participants will assess their health status, by telephone, at recruitment (M0) and at 3 months (M3) with CARE© with the help of their family caregivers.
- The principal investigator or a representative will contact them by phone within 5 days of the CARE© assessment to complete ESOGER.
Phase 2
- Participants will assess their health status, at home, at recruitment (M0), at 3 months (M3), and at 6 months (M6) on the CARE© application with the help of their family caregivers. An additional assessment will take place over the phone by the principal investigator or one of his representatives.
- If their health status is considered fragile, then individuals will be contacted by phone by the PI or one of his representatives to complete the ESOGER© questionnaire (at M0, M3 and M6).
结局指标
主要结局
Response Rate to CARE© questionnaires
时间窗: 4 months
Response Rate to CARE© questionnaires and the time required to complete the questionnaires. For phase 1 only.
CARE© Score
时间窗: 8 months
Measure of frailty via a standardized self-questionnaire consisting of 22 simple questions. The CARE© score ranges from 0 (no deficits) to 21 (maximum cumulative deficits). This score has been segmented into 3 levels according to a validated approach in order to determine 3 levels of frailty which are : * The robust level: score between 0 and 1. * The pre-fragile level: score between 2 and 4. * The fragile level: score \> 5. For phase 1 : evaluated at M0 and M3, and the variation between M0 and M3. For phase 2 : evaluated at M0, M3 and M6, and the variation between the three periods.
次要结局
- Psychological stress(8 months)
- Number of recommendations followed by participants(8 months)
- BGA Score(8 months)
- Social Isolation(8 months)
- Consumption of services and care resources(8 months)
- COVID-19 symptoms(8 months)
- Loss of autonomy(8 months)
- Quality of life of participants(8 months)
- Caregiver burden(8 months)
- Number of completed questionnaires and recommendations given(8 months)
研究者
Olivier Beauchet
MD, PhD, Senior researcher, Director of laboratory
Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal