Healthy Lifestyle Habits Promotion to Improve Elderly People Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 2
- 主要终点
- Changes in Quality of Life by EuroQoL-5D
研究概览
简要总结
The GATEKEEPER project, funded by the European Commission's HORIZON 2020 innovation framework, aims to ensure healthier independent living for ageing populations. To this end, GATEKEEPER aims to develop an open, European-wide, standards-based, interoperable and secure platform, available to all stakeholders (healthcare professionals, technology companies and users), offering digital solutions on the Internet of Things, Big Data or Artificial Intelligence, or new techniques, for early detection and personalised interventions to ensure healthier independent living for ageing populations.
GATEKEEPER will demonstrate its value by scaling up innovative solutions, during a 48-month work plan that will involve 40.000 elderly citizens, as well as authorities, institutions, companies, associations and academic centres from 8 pilot regions in 7 EU Member States. The pilots sites will deploy and demonstrate the effect, benefit, value and scalability of GATEKEEPER solutions around reference use cases covering primary, secondary and terciary prevention in the Basque Country (Spain), Aragon (Spain), Attica and Central Greece (Greece), Cyprus (Cyprus), Lodz (Poland), Milton Keynes (UK), Puglia (Italy) and Saxony (Germany).
The Basque Country pilot site is involved in the Reference Use Cases focused to "Lifestyle-related early detection". The intervention aims to encourage active and healthy ageing by the use of a self-managed mobile application, thereby to enhance independence, autonomy and improve the well-being of older people, promoting their physical, cognitive and mental activity and social participation. This quasi-experimental and longitudinal study is target to 10,000 older people and/or their caregivers from the Basque Country region. A multi-channel and community-based recruitment strategy at Basque regional level has been designed that involves 39 community-based organizations from the Basque Health Ecosystem.
详细描述
The population over 65 years of age in OECD (Organisation for Economic Co-operation and Development) countries has been increasing in recent years. In 2010 it was 15% and is expected to reach 22% by 2030. Life expectancy of people aged 65 has also increased significantly over the last 50 years, being higher in OECD countries, with women living 21 years longer and men 17 years longer, representing an increase of almost 40% since 1960. This demographic change of society in the European Union (EU) leads to increased costs in health and social care systems, as care and prevention measures for all ages are becoming increasingly expensive.
To tackle this challege, health systems should identify solutions that improve the lifelong health and well-being of elderly people, and hence the effectiveness of prevention, treatment and management of disease and disability.
The European funded GATEKEEPER project aims to ensure healthier independent living for ageing populations. As a result, GATEKEEPER will deploy an open, European-wide, standards-based, interoperable and secure platform, available to all stakeholders (healthcare professionals, technology companies and users), offering digital solutions on the Internet of Things, Big Data or Artificial Intelligence, or new techniques, for early detection and personalised interventions to ensure healthier independent living for ageing populations. The study will engage 40,000 senior citizens, as well as authorities, institutions, companies, associations and academic centres from 8 pilot regions in seven medical use cases.
The Basque Country region participates the "Lifestyle-related early detection" use case. It has implemented a health promotion intervention to encourage active and healthy ageing of Basque elderly people by the use of a self-managed MAHA mobile application. The main objective is to assess the effectiveness and user experience of a self-managed mobile health application that recommends activities to promote healthy lifestyle habits. Secondary objectives are:
- To encourage active and healthy ageing, promoting physical activity, cognitive training and social participation.
- To enhance independence, autonomy and improve the well-being of older people.
- To increase the empowerment of older people and their caregivers, family members or reference people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •PARTICIPANTS -Inclusion criteria
- •Subjects are eligible for the study if they are:
- •65 years of age or older and/or their caregiver, family members and reference people
- •With stable internet access and at least one of the following devices to use the GATEKEEPER application: Smartphone or Tablet
- •They or their informal caregivers understand, read and talk the native language.
- •PARTICIPANTS -
排除标准
- •Patients are not eligible for recruitment if:
- •Aged < 65 years
- •Do not have access to internet or at least one of the following devices to use the GATEKEEPER application: Smartphone or Tablet
- •INFORMAL CAREGIVERS- Inclusion criteria
- •The informal caregiver will be a person who provides occasional or regular support to the participant. Caregivers are eligible if:
- •The participant they take care of meet the inclusion criteria
- •They have stable internet access and at least one of the following devices to use the GATEKEEPER application: Smartphone or Tablet
- •INFORMAL CAREGIVERS-Exclusion criteria Caregivers are not eligible if the user meets the exclusion criteria.
- •PROFESSIONALS-Inclusion criteria
- •Professionals are eligible if they have a direct connection with participants who meet the inclusion criteria and accept to participate. Professionals taking part in GATEKEEPER intervention should be:
- •open to the use of new technology. They should be willing to learn how to use technology to support users if needed.
- •PROFESSIONALS-Exclusion criteria Professionals are not eligible if they do not care for users who meets the inclusion criteria or only care for patients who meet the exclusion criteria.
结局指标
主要结局
Changes in Quality of Life by EuroQoL-5D
时间窗: Change from baseline quality of life at 6 months
EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Get up from the chair 5 times test
时间窗: Change from baseline result of the test at 6 months
The Get up from your chair 5 times test is aimed at measuring the participant's functionality. It assesses the muscular power of the lower limbs during the exercise of getting up and sitting down from the chair.
次要结局
- App usage by users(Up to 12 months)
- App Usability Questionnaire MAUQ(Up to 6 months)