Effect of a Person-centred Care Intervention on the Social Dimension of People With Chronic Heart Failure: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 374
- 试验地点
- 2
- 主要终点
- Evaluate the effect of a PCC intervention on the ability to participate in social roles and activities in individuals with CHF.
研究概览
简要总结
People with Chronic Heart Failure (CHF) live with a complex situation that significantly affects their quality of life and well-being. Among the consequences of CHF that have the greatest impact on individuals is the effect it has on their social dimension. The symptomatic burden they experience, along with the influence of social determinants, social support, and psychosocial factors, results in disability and limitations in maintaining an adequate social life and roles, participating in social events, and having relationships beyond their closest family circle. Various international health organizations have emphasized the need to move towards Person-Centered Care (PCC). Adopting this approach involves shifting from a model in which the patient is a passive subject of a medical intervention to one in which the patient takes an active role in their care and decision-making process. The aim of this study is to assess the effectiveness of a PCC intervention on the social dimension of people with CHF. The study will be conducted at the Outpatient Heart Failure Units of Donostia University Hospital, the University Hospital of Navarra, and the University of Navarra Clinic in Pamplona. A randomized controlled, open-label, parallel-group, multicenter clinical trial will be carried out, based on the Medical Research Council framework. This will evaluate the effect of a three-month intervention consisting of in-person and telephone support centered on the person, in addition to usual care, compared to usual care alone, in a sample of 374 individuals. The intervention will be implemented by a multidisciplinary team comprising nurses, doctors, social workers, and psychologists from each hospital. Through this intervention, a patient narrative will be obtained regarding their goals, desires, capabilities, and resources related to their health situation. A health plan will be jointly created that will reflect short- and long-term goals, identify the resources available to the person and in their immediate environment, and outline how they want and expect to receive support from healthcare professionals. To assess its impact, the intervention's effect on the ability to participate in social roles and activities, perceived level of social isolation, and perception of social support will be measured. Additionally, the effect on self-efficacy perception, level of self-care and treatment adherence, anxiety and depression, and overall health experience with the disease will be evaluated, as well as rates of hospitalization, disease decompensation, emergency visits, and death.
详细描述
Background According to the WHO, heart disease has been the leading cause of mortality worldwide for the past 20 years. Specifically, people with Chronic Heart Failure (CHF) have become a priority group in healthcare systems. The prevalence of CHF in the adult population of industrialized countries reaches 3% and is expected to increase due to its chronic and progressive nature, driven by advances in healthcare. Currently, women make up 50.3% of the global prevalence, and it has been found that more than 10% of people over 70 suffer from it.
Several studies have shown that people with CHF live in a complex situation that significantly impacts their quality of life and overall well-being. This is because, on one hand, they must cope with complex treatment regimens, strict self-care behaviors, and lifestyle changes that affect their daily lives. On the other hand, they experience situations that lead to profound changes in all their personal dimensions, including physical restrictions, emotional and spiritual needs, and the impact on family and social roles. Despite this, the healthcare provided to these patients, as is the case with other chronic conditions, primarily focuses on disease management and the prevention of complications, while other aspects related to the experience of living with CHF are not being addressed.
Healthcare systems need to reorganize to provide high-quality care without increasing costs to an aging population with a high prevalence of chronic and long-term conditions. Several leading international health organizations, including the World Health Organization and the National Academy of Medicine, have emphasized the need to move toward increasingly person-centered healthcare systems. When healthcare is provided within the framework of Person-Centered Care (PCC), personal experiences, life stories, family, environment, and goals and desires are considered when planning health-related aspects. Each individual's subjectivity must be regarded as how they integrate into their environment and what their strengths and weaknesses, future plans, and rights are.
The SHARE study is expected to improve several key outcome indicators that enhance individuals' life experiences by combining current healthcare with the PCC approach. By reducing care demand, it will also contribute to the sustainability of the healthcare system.
Design This is an open-label, multicenter, randomized controlled clinical trial with parallel groups. It will be conducted as a superiority trial, where treatment comparisons will be made using "intention-to-treat" analysis. The study is based on the methodological framework of the Medical Research Council (MRC), which guides the development and evaluation of complex interventions. This research mainly focuses on studying effectiveness, i.e., to what extent the intervention achieves the intended outcomes in a real-world setting. The effect of a PCC intervention, in addition to the usual care received by individuals with CHF (intervention group), will be compared to usual care alone (control group).
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
盲法说明
The nature of the intervention means that neither participants nor the health care professionals in the SHARE intervention can be blinded to allocation in the RCT.
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
- •Individuals over 18 years old;
- •Functional class II-IV according to the NYHA;
- •Adequate cognitive status and health condition that allows participation;
- •Adequate spoken and written Spanish proficiency;
- •Active phone line; and
- •Voluntary signature of informed consent.
排除标准
- •Having a severe concurrent illness;
- •Life expectancy of less than 1 year;
- •Receiving palliative care;
- •Severe hearing impairment; and
- •Known alcohol or drug abuse.
结局指标
主要结局
Evaluate the effect of a PCC intervention on the ability to participate in social roles and activities in individuals with CHF.
时间窗: Baseline, 3, 6 months.
Neuro-QOL Item Bank v1.0 - Ability to Participate in Social Roles and Activities - Short Form A. (58). It consists of 7 items. Although originally designed for administration to individuals with chronic neurological conditions, this tool has been shown to be valid for use in other chronic conditions. It assesses the degree of participation in usual social roles, activities, and responsibilities, including work, family, friends, and leisure.
Evaluate the effect of a PCC intervention on perceived self-efficacy in individuals with CHF.
时间窗: Baseline, 3, 6 months.
General Self-Efficacy Scale (GSE) (60). This scale consists of 10 items and assesses the strength of an individual's belief in their own ability to respond to new or challenging situations and to overcome obstacles and setbacks.
次要结局
- Evaluate the effect of a PCC intervention on the perceived level of social isolation in individuals with CHF.(Time Frame: Baseline, 3, 6 months.)
- Evaluate the effect of a PCC intervention on the perceived social support in individuals with CHF.(Baseline, 3, 6 months.)
- Evaluate the effect of a PCC intervention on self-care behaviors in individuals with CHF.(Baseline, 3, 6 months.)
- Evaluate the effect of a PCC intervention on the experience of living with CHF.(Baseline, 3, 6 months.)
- Evaluate the effect of a PCC intervention on the quality of life of individuals with CHF.(Baseline, 3, 6 months.)
- Evaluate the effect of a PCC intervention on anxiety and depression levels in individuals with CHF.(Baseline, 3, 6 months.)
研究者
Maddi Olano
Associate Professor
Clinica Universidad de Navarra, Universidad de Navarra