Feasibility and Acceptability of a Web-based Multidomain Intervention With Connected Devices Made to Maintain Cognitive Function in Older Adults: a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Compliance to the protocol
研究概览
简要总结
The primary purpose of the protocol is to evaluate the feasibility and acceptability of a home-based (using information and communication technologies) intervention composed of nutritional counselling, exercise and cognitive training in older adults and its potential effect on various health outcomes.
详细描述
Nutritional interventions, physical exercise and cognitive training have been used to delay cognitive decline during aging, with mixed results being obtained. However, few studies have investigated the health benefits of combining two or more of those interventions (ie, the so-called multidomain approach) in older adults. Intensive in-person multidomain intervention may difficultly be translated into the "real world" of healthcare systems because currently unpractical.
Therefore, (cost-)effective interventions provided at distance and without the physical presence of healthcare professionals have the potential to be better translatable from research to real life. Information and Communications Technologies (ICT) have a crucial role to play in this context. However, to the best of our knowledge, no studies have investigated the effects of an ICT multidomain intervention on cognition in the elderly yet.
Thus, the main objective of eMIND is to test the feasibility and acceptability of a 6-month, home-based multidomain intervention composed of nutritional counselling, exercise, and cognitive training provided using ICT solutions in people aged 65 or over.
Secondary objectives include to obtaining preliminary data on the effects of the intervention on clinical outcomes in order to inform the design and sample size calculations of a future trial.
eMIND has a mixed design, being composed of a randomized controlled trial (RCT, with two groups: the ICT multidomain intervention group vs Control Group) and a qualitative study (semi-structured interview to assess the easiness-of-use of the website).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Mini-mental State Examination ≥ 24
- •Presenting subjective memory complaints
- •Have easy access to internet (defined as Internet access at home or elsewhere at least twice a week)
排除标准
- •Terminal illness with life expectancy less than 6 months;
- •Diagnosis of dementia of any subtype according with DSM-V
- •diagnosis of neurodegenerative diseases, particularly Parkinson's disease;
- •Major depression
- •unstable cardiovascular condition or any other health condition that might be deteriorated by physical exercise;
- •Dependency in ≥ 1 activity of daily living (basic ADL) already participating in structured sessions of physical exercise or cognitive stimulation ≥ 2 times/week in the last 2 months prior to the date of baseline assessments
研究组 & 干预措施
Multidomain Intervention Group
Home-based multidomain intervention composed of nutritional counselling, exercise (balance, gait, , and cognitive training provided using ICT solutions. A web platform, containing information, questionnaires, videos, games, and tests related to each one of the three components of the multidomain intervention will be made available to participants in this group.
干预措施: ICT Multidomain Intervention Training (Device)
Control Group
Participants from CG will also be equipped with wrist worn accelerometers (that will record daily activity data continuously) but contrary to MIG, participants won't have access to the password encrypted application, and therefore, to the multidomain intervention. However, they will be able to access the study website with overall information on the eMIND study and links to the website of health authorities (such as "http://www.mangerbouger.fr/PNNS" or the World Health Organization "http://www.who.int/topics/ageing/fr/") regarding healthy ageing topics. Plus, in order to control for the social aspect of MIG, participants in CG will receive monthly phone calls from the research team.
干预措施: ICT Multidomain Intervention Training (Device)
结局指标
主要结局
Compliance to the protocol
时间窗: Assessment at the end of the intervention: 6 months after the inclusion
Compliance to measure the feasibility of the study: Participants will be asked to connect the physical exercise interface at least twice a week, the cognitive stimulation interface at least twice a week, and the nutritional interface at least once each 15 days. Participants who adhere to \>75% of this frequency of web-site use will be considered adheres (quantitative approach)
Content analysis from recorded interviews
时间窗: Assessment at the end of the intervention: 6 months after the inclusion
a content analysis from recorded interviews that will be conducted at the end of the intervention period to measure the acceptability of the trial procedures (qualitative approach)
次要结局
- Score from MMSE(Assessment of these measures at the end of the intervention: 6 months after the inclusion)
- Score FCSRT(Assessment of these measures at the end of the intervention: 6 months after the inclusion)
- Score DSST(Assessment of these measures at the end of the intervention: 6 months after the inclusion)
- Score Fluency tests(Assessment of these measures at the end of the intervention: 6 months after the inclusion)
- Short Physical Performance Battery(Assessment of these measures at the end of the intervention: 6 months after the inclusion)
- Health-related quality of life and Health economic Euro-QoL 5D-3L(Assessment of these measures at the end of the intervention: 6 months after the inclusion)
- Physical activity Monitoring(Assessment of these measures at the end of the intervention: 6 months after the inclusion)
- Mini-Nutritional Assessment (MNA)(Assessment of these measures at the end of the intervention: 6 months after the inclusion)