Longterm Follow-up of Cardiac Patients With an Smartphone-Application -A Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Change in Maximal oxygen consumption
研究概览
简要总结
Cardiovascular disease is the leading cause of morbidity and mortality globally. Cardiac rehabilitation (CR) including exercise training are effective to reduce morbidity, mortality and risk factors such as physical fitness, cholesterol, triglycerides and blood pressure. The main goal for CR is to establish exercise training and other lifestyle changes as permanent changes in the patient's life. Many studies have shown that cardiac patients strive to maintain a heart-healthy lifestyle, one year after participating in CR. Furthermore, this leads to risk profile returning to the starting point where they got their Cardiac event. Changing a lifestyle is known to take time, and we believe that the patients need further follow-up beyond the time spent in traditional CR.
To our knowledge very few, if any, studies evaluates the use of modern technology in longterm follow-up focusing on maintaining a new lifestyle after participating in CR. The investigators would like to evaluate the effect of an dynamic application (app) with regard to physical fitness, lifestyle and quality of life (QoL), one year after CR. The investigators hypothesize that patients getting Access to a dynamic Application and tailored feedback through the application after CR will better be able to take care of physical Fitness and other lifestyle factors one year after CR, compared to patients getting usal care.
详细描述
Introduction:
Smartphones are widespread and in 2015 as much as 82% of the Norwegian population were owners of a smartphone. Recommendations has been pointed out in a new report from the Norwegian Board of Technology; health service should facilitate so that patients can follow up their health from home and simultaneously receive necessary help from the health service. The Norwegian Directorate of health points in a national action plan for e-health that evidence based digital tools in combination with an increase of competence will make it possible to reach health political goals such as quality levels, patient safety and an effective use of resources.
Across diseases adherence to treatment is one of the most important modifiable factors wich decreases the treatment effect. As much as 30-50% of patients do not adhere to recommended treatment. Adherence to treatment is complex and it depends on many factors; the patient, the patient surroundings (social support, the function of the health service, availability and resources) and characteristics with the disease and the corresponding treatment. World Health Organization (WHO) points to adherence to treatment as a global challenge and supports political decisions and research interventions that will increase adherence. Furthermore, adherence is considered to be a huge challenge in treatment for lifestyle changes such as smoking cessation, diet changes, training and physical activity. A meta-analysis (n=42 000) documented that "mixed mode of delivery interventions", where traditional techniques for behavior change was combined with digital tools, proved more effective than the use of traditional techniques for behavior change alone. Another meta-analysis (n=20 000) confirms this conclusion; therapy, guidance and conversation has an increased effect when it is used together with dedicated digital tools (6).
Cardiovascular disease is the leading cause of morbidity and mortality globally. Cardiac rehabilitation (CR) including exercise training are effective to reduce morbidity, mortality and modifiable risk factors such as physical fitness, cholesterol, triglycerides and blood pressure. The main goal for CR is to establish exercise training and other lifestyle changes as permanent changes in the patient's life. Many studies have shown that cardiac patients do not reach the therapeutic goals regarding secondary prophylaxis one year after participating in CR. In other words; patients are not able to maintain the new lifestyle after CR and their risk profile goes back to base. Changing a lifestyle is known to take time, and we believe that the patients need further follow-up beyond the time spent in traditional CR.
To our knowledge very few studies, if any, evaluates the use of modern technology aiming to help the patients to maintain a new lifestyle after participating in CR. The investigators would therefore like to implement a randomized clinical trial (RCT) to evaluate the effect of the dynamic Application Vett® With regard to physical Fitness (peak oxygen uptake), one year after CR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
The cardiologist, physical therapist and the physiologist at NIMI and Feiring will be masked.
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Finished Cardiac rehabilitation at NIMI or Feiring
- •≥ 40 years old
- •Owner and user of a Smartphone
- •Understanding basic Norwegian or English
排除标准
- •Severe malignant disease that affects the patient's life to a greater extent than the heart disease
- •Musculoskeletal- changes or diseases, that affect the patient's physical capacity and quality of life more than their heart disease
- •Ischemia or arrytmia at treadmill test which gives the patient restrictions regarding exercise intensity equivalent >80% av HFmax eller BORG scale >15
研究组 & 干预措施
Smartphone-Application
Patients in "Smartphone-Application"-arm will get Access to the Application Vett, they will be learned how to use it. They will receive feedback based on their goals and tasks in the Application for one year, and they will also receive motivational Notifications through the Application, atleast once a week in the follow-up period. Patients in this arm will also have the possibility to send questions to their supervisor through the Application, in that case they will receive answer within two working days. In addition they will receive usual care which is described below.
干预措施: Smartphone-Application (Device)
Control-group
Patients in the control-group will receive usual care consisting of general advice according to a heart-friendly lifestyle and follow-up by their general practitioner.
结局指标
主要结局
Change in Maximal oxygen consumption
时间窗: Change from baseline to 12 months
Physical capacity will be evaluated With maximal oxygen consumption. We will do a cardiorespiratory Fitness test on a treadmill With a standardized ramp-protocol and Direct measurement of oxygen consumption
次要结局
- Change in Endurance Fitness(Change from baseline to 12 months)
- Change in Quality of Life(Change from baseline to 12 months)
- Type D personality(Baseline)
- Change in Health Literacy(Change from baseline to 12 months)
