REMIND HF - Evaluation of Remote Motivational Interviewing for Disease Management in Heart Failure Patients and Their Carers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Change from Baseline in Patient Self-Care as Measured by the Self-Care of Heart Failure Index
研究概览
简要总结
Heart failure (HF) is a chronic and progressive condition that significantly affects patients' quality of life and increases the burden on family caregivers. Many patients struggle with self-care, including medication adherence, diet, and symptom monitoring.
The REMIND HF (REmote Motivational INterviewing for Disease Management in Heart Failure) study aims to evaluate the effectiveness of remote motivational interviewing (MI) as a behavioral intervention to improve disease management and self-care among heart failure patients and their informal caregivers. The intervention consists of a series of online motivational interviews conducted by trained nurses over a 12-month period, focusing on lifestyle modification, self-monitoring, and patient-caregiver cooperation.
The study will be conducted at the Wroclaw Medical University and collaborating centers. It will enroll 300 patients with heart failure (The New York Heart Association Functional Classificaion - NYHA class: II-IV) and their primary caregivers. Outcomes will include self-care behaviors, quality of life, psychological well-being, and health service utilization. The results will contribute to developing accessible, patient-centered models of heart failure management based on telehealth and behavioral support.
详细描述
Background and Rationale:
Heart failure is a chronic, progressive, and life-limiting syndrome characterized by frequent hospitalizations, reduced quality of life, and high mortality. Despite advances in pharmacological and device-based treatments, effective disease management continues to rely heavily on the patient's and caregiver's ability to perform adequate self-care behaviors. These include medication adherence, symptom monitoring, dietary control, physical activity, and timely medical contact in case of deterioration.
Numerous studies demonstrate that self-care in HF remains suboptimal. Poor adherence is often related to low health literacy, cognitive decline, depression, or limited support from family and healthcare providers. Informal caregivers play a central role in assisting patients, yet they experience significant burden, anxiety, and uncertainty regarding effective disease management. Interventions aimed at improving both patient and caregiver engagement are critical for better health outcomes.
Motivational interviewing is a structured, patient-centered counseling technique designed to enhance intrinsic motivation for behavior change by exploring ambivalence and strengthening commitment. MI has been successfully applied in chronic disease management and has shown promise in improving self-care and adherence in cardiovascular populations. Remote delivery of MI using telecommunication tools can increase accessibility, continuity, and cost-effectiveness of support for patients with heart failure.
The REMIND HF study has been developed to evaluate the efficacy of remote nurse-delivered motivational interviewing in improving self-care behaviors among patients with heart failure and their informal caregivers. The project is conducted at the Wroclaw Medical University (Poland) and funded by the National Science Centre (NCN, OPUS 27 grant).
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
This is an open-label study. Due to the behavioral nature of the intervention, neither participants, care providers, investigators, nor outcome assessors are blinded to group assignment.
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
- •Adult patients aged 18 years or older.
- •Diagnosis of heart failure.
- •New York Heart Association (NYHA) functional class II-IV.
- •Poor self-care as assessed at baseline.
- •Receiving care at the participating heart failure clinic.
- •Access to the internet and a device capable of videoconferencing.
- •Ability to understand the study procedures and provide written informed consent.
- •Having an identified primary informal caregiver willing to participate in the study.
- •Informal caregivers aged 18 years or older.
- •Caregivers identified by the patient as the primary person providing unpaid support in daily disease management.
- •Caregivers able to understand the study procedures and provide written informed consent.
排除标准
- •Severe cognitive impairment that would limit the ability to participate in the intervention or complete study assessments.
- •Acute coronary syndrome or other acute cardiac event within the last 3 months.
- •Residence in a nursing home or long-term care facility.
- •Inability to participate in videoconferencing sessions.
- •Participation in another interventional study that could interfere with the outcomes of this trial.
研究组 & 干预措施
Remote Motivational Interviewing plus Standard Care
Participants assigned to this arm will receive remote motivational interviewing delivered via secure videoconferencing in addition to standard heart failure care. The intervention will consist of seven motivational interviewing sessions provided over a 12-month period by trained nurses. Sessions will focus on supporting patient self-care behaviors and caregiver contribution to self-care, including symptom monitoring, medication adherence, lifestyle behaviors, and disease management. Participants will continue to receive all components of usual heart failure care throughout the study.
干预措施: Remote Motivational Interviewing (Behavioral)
Standard Care
Participants assigned to this arm will receive standard heart failure care in accordance with current clinical guidelines. Standard care may include routine outpatient follow-up, pharmacological treatment, patient education, and access to usual healthcare services, without additional motivational interviewing sessions.
干预措施: Standard Heart Failure Care (Other)
结局指标
主要结局
Change from Baseline in Patient Self-Care as Measured by the Self-Care of Heart Failure Index
时间窗: From baseline to 12 months after enrollment.
Patient self-care will be assessed using the Self-Care of Heart Failure Index (SCHFI). The SCHFI is a validated questionnaire that evaluates heart failure self-care behaviors across three domains: self-care maintenance, self-care management, and self-care confidence. Each domain score is standardized on a 0-100 scale, with higher scores indicating better self-care. Change from baseline in SCHFI scores will be analyzed to assess the effect of the intervention.
次要结局
- Change from Baseline in Health-Related Quality of Life as Measured by the SF-12v2 Health Survey(From baseline to 12 months after enrollment.)
- Change from Baseline in Heart Failure-Specific Quality of Life as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)(From baseline to 12 months after enrollment.)
- Change from Baseline in Anxiety Symptoms as Measured by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)(From baseline to 12 months after enrollment.)
- Change from Baseline in Depressive Symptoms as Measured by the Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D).(From baseline to 12 months after enrollment.)
- Number of Heart Failure-Related Hospitalizations(From enrollment to 12 months after enrollment.)
- Change from Baseline in Caregiver Contribution to Patient Self-Care(From baseline to 12 months after enrollment.)
- All-Cause Mortality(From enrollment to 12 months after enrollment.)
- Incremental Cost-Effectiveness of Remote Motivational Interviewing Compared to Standard Care(From enrollment to 12 months after enrollment.)