Development and Efficiency of an mHealth Intervention on the Health Literacy Improvement and Self-management of the Multi-pathological Patient With Heart Failure: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 236
- 试验地点
- 4
- 主要终点
- Health literacy
研究概览
简要总结
Multipathological patients with complex health needs are responsible for the majority number of avoidable hospital admissions.
The expansion of mHealth interventions in the field of communication with the patient, the reduction of health inequalities, the improvement in access to health resources, the adherence to treatments and self-care of chronic diseases lead to an optimistic horizon . However, there are few applications that demonstrate its effectiveness in these patients, which is diminished when they are not based on evidence, nor are designed by and for users with different levels of health literacy.
详细描述
Objective
to evaluate the efficacy of an mHealth intervention, with respect to routine clinical practice, to improve health literacy and self-management of the multiple pathological patient with heart failure and complex health needs.
Hypothesis
the proposed mHealth intervention is more effective than usual clinical practice, favoring health literacy and self-management of multiple pathological patients with heart failure and complex health needs, so its use would be relevant as part of the assistance process.
Methodology: randomized, controlled, multicenter clinical trial for the evaluation of the efficacy of an mHealth intervention with two groups: a control group (routine clinical practice) and an experimental group (routine clinical practice together with ad hoc designed mHealth intervention).
In this project, the design and content validation of the mHealth tool will be carried out, evaluating its relevance and suitability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patients of both sexes and over 18 years of age;
- •Attended by the health professionals of the Basic Health Areas that are participating in the study;
- •Patients that give their consent to participate in the study by signing an informed consent;
- •Patients that have a mobile device (Smartphone or Tablet) compatible with the Android or iOS operating system;
- •Patients considered as multi-pathological based on the following criteria from those described in the Integrated Healthcare Process (Ollero et al., 2018):
- •Be classified in clinical category A of chronic pathologies due to heart failure that, in a situation of clinical stability, has been in NYHA grade II, being able to be simultaneously classified, or not, in other clinical categories due to suffering from another disease Chronicles.
- •Patients with at least one of the following complexity criteria: Extreme polypharmacy (10 or more active ingredients for chronic prescription); Socio-family risk (score on the Gijon scale greater than 10 points); Stage II or higher pressure ulcers; Malnutrition (BMI <18.5); Feeding with chronic and prescription tube (3 or more months); Two or more hospital admissions in the previous 12 months.
排除标准
- •Patients with sensory deficits and/or mobility problems in the upper limbs that prevent them from using the application correctly, despite using the accessibility features of mobile devices;
- •Patients with persistent cognitive impairment (Pfeiffer test with 5 or more errors or Lobo's mini-cognitive exam <23 points) and / or severe mental disorder;
- •Patients with serious limitations for AVBD (Barthel index <20 points).
结局指标
主要结局
Health literacy
时间窗: 1 year
Literacy on health defined by points (range 0-50)
General selfmanagement
时间窗: 1 year
Selfmanagement on health (scale 1-5)
selfmanagement on heart failure
时间窗: 1 year
European Heart Failure SelfCare Behavior Scale (range 12-60)
次要结局
- self-independence 2(1 year)
- Patient satisfaction(1 year)
- Prognosis(1 year)
- Patient satisfaction 2(1 year)
- self-independence(1 year)
- Adherence to treatments(1 year)