Gamified Smartphone Application to Improve the Adherence to the Mediterranean Diet in Cardiac Patients: a Usability and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Acceptance
研究概览
简要总结
The study is a pilot study (phase 2) that includes a usability study (phase 1).
The aim of the study is to investigate the feasibility and usability of the healthy nutrition application and the effects on adherence to Modified Mediterranean diet, self-efficacy and nutrition knowledge among patients with cardiovascular disease in a cardiac rehabilitation setting. Furthermore, it studies the overall user experience when using the healthy nutrition application.
详细描述
The study can be divided in two phases, each one addressing a specific research question:
- Usability: Is the developed healthy nutrition application user-friendly and does it seem motivating for cardiac patients in a cardiac rehabilitation setting to use the application to eat more healthily?
- Pilot study: Is the developed healthy nutrition application feasible and acceptable for cardiac patients? Does the healthy nutrition application have an effect on adherence to Modified Mediterranean diet, self-efficacy and nutrition knowledge in cardiac patients in a cardiac rehabilitation setting and what is the user experience?
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •History of cardiovascular disease with or without intervention (PCI/CABG/conservative/pacemaker implantation/ablation)
- •History of current or past cardiac rehabilitation in Jessa Hospital Hasselt
- •Current treatment must require them to follow the Mediterranean diet plan
- •Age ≥18 years
- •Willing and physically able to follow a application-based healthy nutrition program and other study procedures in a six-week follow-up period
- •Evidence of a personally signed and dated informed consent, indicating that the subject (or a legally-recognized representative) has been informed of all pertinent aspects of the study
- •Possession of and/or able to use an Android based smartphone (version 6 or higher)
- •Possession of internet connectivity
- •Dutch speaking and understanding
排除标准
- •Pregnant females
- •Combined with diabetes or severe kidney disease
- •Participation in other cardiac rehabilitation program trials, focusing on diet outcome
- •Current or recent participation in other technology-supported programs, even when not directly targeting nutrition
- •Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study or a life expectancy of less than six weeks based on investigators judgment
结局指标
主要结局
Acceptance
时间窗: Six week
The acceptance is measured by Self-reported habit index(SRHI). It includes 12 items, we use 7-point Likert scale. Scores ranged from 12 to 84. The higher the score, the higher the acceptability.
Motivation
时间窗: Six week
Motivation is measured by Intrinsic Motivation Inventory(IMI), it includes 18 items, we use 5-point Likert scale, the scores range from 18 to 90. Higher score means higher motivation.
Application visits
时间窗: During the whole six week
Usability is also measured by the objective index "application visits", the visits to each page/component of the application during the whole six week are recorded in the application.
Usability
时间窗: Six week
The usability questionnaire asks patients to evaluate various components of the application based on perceived usefulness, ease of use and ease of understanding, as well as visual attractiveness and contains various questions specific to each component. The questionnaire includes 109 questions, we use 5-point Likert scale. The higher score means better usability.
次要结局
- Change from baseline Adherence to Mediterranean diet at 6 weeks(Baseline and six week)
- Change from Self-efficacy at 6 weeks(Baseline and Six week)
- Digital health literacy(Baseline)
- Change from Knowledge at 6 weeks(Baseline and six week)