BreinZorg: A Feasibility Study Into an Online Lifestyle Platform for Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Demand of the new online website. Website usage data.
研究概览
简要总结
Dementia is the most common disease in older individuals and this century's biggest healthcare challenge. Many patients who visit the memory clinic with memory complaints do not have dementia but instead are diagnosed with mild cognitive impairment (MCI) or subjective cognitive decline (SCD). MCI or SCD may be a pre-dementia stage. Many patients with MCI or SCD often leave their consultation with unanswered questions, and unsure what they, themselves can do to reduce dementia risk. Patients with MCI and SCD have a heightened risk of developing dementia. Therefore, this group would possibly benefit most from preventive strategies. Around 40% of dementia cases is attributable to modifiable factors. Thus, managing a healthy lifestyle may reduce dementia risk.
To answer the information request many patients have when leaving the memory clinic and to fill the knowledge gap an online tool has been developed.
The goal of this mixed-method feasibility study is to investigate the usability, feasibility, patient experience, and effectiveness of the personalized, multi-domain online website in older adults with MCI or SCD.
The main questions it aims to answer are:
- Is the new website being used by the target population?
- How does the target population experience the use of the website?
- What is the effect of using the website?
Participants will have access to the website and are free to use the website in any way they want.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 61 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Visited a memory clinic;
- •Recent (no longer than 4 months) diagnosis of MCI or SCD according to the guidelines used in the memory clinic;
- •>60 years of age;
- •Sufficient fluency in Dutch;
- •Internet access at home and a working e-mail address;
- •Sufficient hearing and vision to read, watch and hear content on the website.
排除标准
- •Diagnosis of Dementia according to the guidelines of the memory clinic;
- •Any condition to hinder successful 6-month follow-up;
- •Diagnosis of Major depression;
- •Coincident participation in any other intervention trial at time of pre-screening.
结局指标
主要结局
Demand of the new online website. Website usage data.
时间窗: After 3 months and after 6 months
The estimated use or actual use of the intervention.Monitoring data on the use of the website. How much time do participants spend on the website, which pages do they use and how many times do they visit the website?
Motivation to change lifestyle for reduction of dementia risk.
时间窗: At baseline, after 3 months and after 6 months
Effectiveness of the website in increasing motivation to make lifestyle changes. This is measured by the Dutch Motivation to Change Lifestyle and Health Behaviours for Dementia Risk Reduction (MCLHB-DRR) questionnaire. The answers to this questionnaire will result in 8 different scores. A score for perceived susceptability, perceived severity, perceived barrieres, perceived benefits, cues to action, general health motivation, self-efficacy, and a total motivation. A higher score means more motivation. The scale goes from 'totally do not agree' to 'totally agree'. scores will range between 27 and 135.
Awareness about dementia risk reduction
时间窗: At baseline, after 3 months and after 6 months
effectiveness of the website in increasing awareness and knowledge on dementia risk reduction. This is measured by a modified version of the awareness survey that has been used in the 'MijnBreinCoach' study. This questionnaire focuses on knowledge about dementia risk reduction by changing lifestyle factors. A higher score means more awareness and knowledge on dementia risk reduction. The scale goes from 'totally do not agree' to 'totally agree'. scores will range between 16 and 80.
Practicality of the new online website.
时间窗: After 3 months
The extent to which the intervention can be delivered. Interviews in a subgroup will contain questions on the burden and barriers of the website. It will also contain questions on the desired frequency, duration, and intensity of the website.
Feeling of control about own life and future.
时间窗: At baseline, after 3 months and after 6 months
Effectiveness of the website in increasing feeling of control. This is measured by the 7-item Pearlin Mastery Scale. The scale goes from 'totally do not agree' to 'totally agree'. A higher score on this questionnaire means the participant has more feeling of control. scores will range between 7 and 35.
Acceptability of the new online website following the theoretical framework of acceptability
时间窗: After 3 months
The perception among the patients that the intervention (website) is agreeable. The investigators collect data by means of a questionnaire following the theoretical framework of acceptability. Assessing 7 constructs of acceptability: Affective attitude, Burden, Ethicality, Perceived effectiveness, intervention coherence, self-efficacy and, opportunity costs. Additionally, qualitative information is on experiences and acceptability is gathered using semi-structured interviews.
Adoption / Uptake of the new online website. Website usage data.
时间窗: After 3 months and after 6 months
The intention, initial decision, or action to try to employ a new intervention. How much and how is the new website used by the participants? The investigators collect monitoring data of the website on usage of the website.
Feeling of trust in yourself and your own abilities.
时间窗: At baseline, after 3 months and after 6 months
Effectiveness of the website in increasing feelings of self-efficacy. This is measured by the General Self-Efficacy Scale (GSES) questionnaire. The scale goes from 'totally do not agree' to 'totally agree'. A higher score on this questionnaire means the participant has more feeling of trust in themselves and their abilities. scores will range between 10 and 50.
次要结局
- Change in Sleep behaviour(At baseline, after 3 months and after 6 months)
- Change in smoking behaviour(At baseline, after 3 months and after 6 months)
- Change in physical exercise.(At baseline, after 3 months and after 6 months)
- Change in Diet.(At baseline,after 3 months and after 6 months)
- Change in alcohol consumption(At baseline, after 3 months and after 6 months)
- Change in cognitive activities.(At baseline, after 3 months and after 6 months)
- Change in Stress levels(At baseline, after 3 months and after 6 months)
- Change in Mental health Quality of Life(At baseline, after 3 months and after 6 months)