Proof-of-concept RCT: A Wearable Mobile Device to Improve Disease Management in Patients With Congestive Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 4
- 主要终点
- Self-reported improvement in self-care and health-related quality of life
研究概览
简要总结
Despite the availability of evidence-based guidelines for disease management in patients with congestive heart failure (CHF), the uptake of these guidelines in clinical practice is sub-optimal and adherence rates are disappointing. Within the HeartMan project, a personal e-health system was developed to help CHF patients manage their disease, with the ultimate goal to improve health-related quality of life (HRQoL). The system uses wrist-band sensors to monitor patients' physical activity and physiological parameters. These data are connected to a decision support system, providing medical advice to patients concerning physical exercise, nutrition, medication intake, clinical measurements, environment management, and mental support. The decision support system is based on predictive models, clinical care guidelines and expert knowledge. The advice will be personalized according to each individual patient's medical and psychological profile, and will be presented to the patient through the user interface of a mobile application on a smartphone. A proof of concept trial with a 1:2 (control:intervention) randomization protocol was designed. The sample size calculation was based on primary outcome data from the previous CHIRON project, showing that 90 patients are needed to show at least -5.8 (± 6 to 8 s.d.) beats/min difference in average daily awake heart rate difference - as a fundamental parameter correlating with patient-reported HRQoL - with 90% power between the two groups. Data collection will include an estimation of exercise capacity based on a six-minute walking test, and questionnaire assessments using standardized instruments. The trial will be initiated in two countries. In order to account for possible drop-outs, 60 patients will be enrolled in Italy and 60 in Belgium (20 control and 40 intervention patients in each country). Target patients are stable ambulatory CHF patients (NYHA class 2-3; reduced left ventricular ejection fraction ≤40%). Eligible patients will be recruited by their treating physician from collaborating medical centers in both countries; they will be enrolled in the trial after giving informed consent for participation. After baseline assessment, patients will be randomized into either the intervention (duration of 6 months) or control (usual care) condition. Data collection will be repeated at the end of the trial.
详细描述
Background:
1-2% of people in the developed world suffer from heart failure (HF), which costs the society around 100 billion USD per year. Although the improvements in treatment have lately decreased the number of hospitalizations and deaths due to HF, the burden still remains high with around half of the HF patients being expected to die within five years and HF being the most frequent cause of hospitalization in people aged over 65.
Since there is no cure available at present, a better management of HF is crucial. A proper disease management may not only relieve symptoms, prevent hospitalization or improve survival, but may also affect the patient's health-related quality of life (HRQoL). The European Society of Cardiology (ESC) Task Force produced evidence-based guidelines for the diagnosis and management of HF, intended to be used by clinical practitioners. Despite the availability of these guidelines, registry data consistently show an insufficient uptake in clinical practice. Of particular concern is the poor implementation of exercise guidelines, even though regular physical activity and structured exercise in CHF patients are strongly recommended. Nonetheless, participation rates of CHF patients in cardiac rehabilitation are generally below 20% in Europe. This calls for more specific recommendations on how to give lifestyle advice to patients in a personalized fashion.
A promising technology for improving disease management in HF may be mobile health (mHealth), which encompasses the use of mobile devices as a support for the practice of medicine. mHealth has already been implemented to provide regular follow-up and physiological monitoring, to ensure safety and detect complications in order to prevent subsequent health care utilization. In addition, it may also be a tool to deliver education and to support patients regarding self-monitoring and self-management. However, evidence on the effectiveness of this approach in HF patients has been mixed. Several meta-analyses suggest clinical benefits, but large clinical trials did not show any effect on readmission or death. Nevertheless, the recent BEAT-HF trial found that remote patient management did not reduce rehospitalization or mortality but reported instead an improvement in quality of life.
Patient-reported outcomes (PROs), such as HRQoL or perceived health status, have increasingly been recognized as outcomes of interest in HF and coronary patients in general. PROs are not surrogates for harder endpoints such as mortality, but rather represent independent outcomes with harder endpoints not necessarily reflecting of how a disease and its symptoms are experienced by the patient. Furthermore, HRQoL and health status have been shown to be predictive of clinical events in patients with HF. These findings show that patients' perceptions of worsening symptoms carry vital prognostic information, and should be implemented in trials evaluating disease management.
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
- 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
- 否
入选标准
- •Willing and able to make use of a smartphone and to give informed consent for participation to the study
- •Ischemic or non- ischemic heart failure disease
- •Functional New York Heart Association (NYHA) class 2-3
- •Reduced left ventricular ejection fraction ≤40%
- •Ambulatory HF patients in stable condition: at least one hospitalization due to their HF once, but no hospitalization during the month before start of the trial or no planned surgery
- •Good cognitive function, if cognitive impairment is suspected the patient will be evaluated by using the Mini Mental State Examination (MMSE)
- •Sufficient knowledge of the native language (Dutch in Belgium, Italian in Italy)
排除标准
- •Heart failure patients who fulfill the above mentioned criteria, but suffer from a concomitant end - stage chronic kidney disease necessitating haemodialysis
- •Heart failure patients who fulfill the above mentioned criteria, but are already participating in a disease management program, influencing the HeartMan intervention
结局指标
主要结局
Self-reported improvement in self-care and health-related quality of life
时间窗: Month 0 (start trial)
Measured by the Self-care of Heart Failure Index and Minnesota Living with Heart Failure Questionnaire
次要结局
- Effect of HeartMan on medication adherence(Month 7 (end trial))
- Effect of HeartMan on sexual activity(Month 7 (end trial))
- Effect of HeartMan on adherence to dietary recommendations(Month 7 (end trial))
- Effect of HeartMan on activity behavior(Month 7 (end trial))
- Effect of HeartMan on illness perception(Month 7 (end trial))
- Effect of psychological interventions in HeartMan - cognitive behavioral therapy and mindfulness exercises - on anxiety and depressive feelings(Month 7 (end trial))
- Effect of HeartMan on exercise tolerance(Month 7 (end trial))
- Evaluation of the user experience of HeartMan to assess the expectations towards the system and the patient's experiences(Month 7 (end trial))