Person-centred Care at Distance for Persons With Chronic Heart Failure (CHF) and/or Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Composite score of changes in general self-efficacy
研究概览
简要总结
The goal of the research project PROTECT is to translate the Person-Centred Care (PCC) principles into an eHealth (the use of information and communication technologies for health) context. A developed PCC eHealth platform will be used as a tool to identify patients´ resources to enhance coping and living with their chronic illness by means of a dialog and partnership with staff and relatives. The PCC eHealth platform will not replace, but instead be used as add on treatment to usual care (guideline directed care).
详细描述
A pilot study and collaboration between patients, relatives and professionals in the research program has clarified the need to develop a PCC eHealth platform. Previous research has shown that eHealth support, where the users are not involved in the process, has a low impact and has highlighted several limitations with respect to: patients' participation in the design process; its anchorage in the home and local environment and opportunities for communication rather than information. Therefore this study has a participatory design which assumes that all users (patients, relatives and health care professionals) are involved in the study design which facilitates implementation. An end-user perspective as a starting point increases the chances that users adapt a positive attitude towards the new system. Person-centred care combined with an eHealth support along the chain of health care showed a 4-fold chance of improved self-efficacy in combination with return to work or prior activity level after an event of acute coronary syndrome.
PCC can be delivered at distance and make health care more effective above and beyond usual care. Inclusion of the principles of PCC in an eHealth support for patients with chronic heart failure (CHF) and/or chronic obstructive pulmonary disease (COPD) will reduce the need for medical care (primary care and hospital admission) amongst these patients by improving self-management, self-efficacy and collaboration in the process of care.
The aim of this project is to implement and evaluate the PCC approach at distance to patients with CHF and/or COPD and their informal care givers to live better and cope more effectively with the disease burden associated with CHF and/or COPD. In the PCC approach, the aims, capabilities and needs of each patient, will be the starting point. Self-care strategies will be reinforced and empowered.
This study is a randomized, open, parallel group intervention study where patients are eligible when they are hospitalized due to worsening CHF and/or COPD. They will be asked before discharge about participation.
Patients admitted to hospital for worsening CHF and/or COPD will be recruited by the research nurses employed in this project from Emergency or on the ward once their condition has stabilized sufficiently.
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •National registration within the Västra Götaland Region (VGR)
- •Men and women listed at a primary care centre in Närhälsan with a history of confirmed diagnosis of COPD and /or CHF
- •Must understand written and spoken Swedish
排除标准
- •Severe impairment that prevents patient from using the eHealth support
- •No registered address
- •Any severe disease with an expected survival < 12 months
- •Cognitive impairment (SPMSQ score >6)
- •Ongoing documented diagnosis of alcohol or drug abuse
- •Other disease that can interfere with follow-up (e.g. severe depression, other severe mental illness)
- •Patient participating in another conflicting randomized study
结局指标
主要结局
Composite score of changes in general self-efficacy
时间窗: baseline, 3, 6, 12, 24 months
The primary efficacy endpoint is a composite score of changes in general self-efficacy 18 based on the General Self-Efficacy Scale (GSE), hospitalization and death. The rationale for such an endpoint is the value of combining patient experience and clinical outcomes. A patient is classified as improved, deteriorated or unchanged: * A patient is classified as deteriorated if any of the following occurred: · at 6 months, self-efficacy has decreased by \> 5 units (the minimal change of clinical significance) or has been admitted to hospital for unscheduled reasons or died. * A patient is classified as improved if: * self-efficacy has increased by \> 5 units and has not been hospitalized. Those who have neither deteriorated nor improved are considered unchanged.
次要结局
- Health-related quality of life (EQ-5D)(3,6,12,24 months)
- Hospital anxiety and depression scale (HADS)(3,6,12,24 months)
- COPD Assessment Test (CAT)(3,6,12,24 months)
- The MRC breathlessness scale(3,6,12,24 months)
- Health care utilization(3,6,12,24 months)
- Incremental cost-utility ratios(3,6,12, 24 months)
- Shortness of breath in heart failure (SOB-HF)(3,6,12,24 months)
- Number of admissions(3, 6, 12, 24 months)
- General self-efficacy scale(3,6,12,24 months)