MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients (MOTIVATE-HF): Study Protocol of a Three-arm Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 510
- 试验地点
- 2
- 主要终点
- Self-care Maintenance in Patients
研究概览
简要总结
The aims of this study will be to evaluate the effect of motivational interviewing (MI) to improve self-care in heart failure (HF) patients and caregiver contributions to HF self-care. Also this study will evaluate the effect of MI on the following secondary outcomes: In HF patients: HF somatic symptom perception, generic and specific quality of life, anxiety and depression, sleep quality, mutuality with caregiver, hospitalizations, use of emergency services, and mortality; In caregivers: generic quality of life, anxiety and depression, mutuality with patient, preparedness, social support and sleep quality.
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
- Single (Outcomes Assessor)
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
- •Diagnosis of HF (for patient), New York Heart Association (NYHA) functional class II- IV (for patient), Inadequate self-care assessed with the Self-Care Heart Failure Index (for patient), Being the informal caregiver of the patients (for caregiver).
排除标准
- •Severe cognitive impairment evaluated with the Six-item screener (for patient), Acute coronary syndrome during the last three months (for patient), Living in a residential settings (e.g., nursing home) (for patient), Patients not willing to participate in the study (for caregiver).
结局指标
主要结局
Self-care Maintenance in Patients
时间窗: 3 months from the intervention
Self-care in HF patients will be measured with the Self-Care of HF Index V.6.2. Since this instrument has three separate scales, we considered as a primary outcome the score of the Self-care Maintenance scale. The Self-Care Maintenance scale has a score between 0 and 100 with higher score meaning better self-care. Self-Care Maintenance is considered adequate when the score is at least 70.
次要结局
- Patient HF Specific Quality of Life(3, 6, 9 and 12 months from the intervention)
- Patient and Caregiver Quality of Nocturnal Sleep(3, 6, 9 and 12 months from the intervention)
- Caregiver Preparedness(3, 6, 9 and 12 months from the intervention)
- Patient and Caregiver Generic Physical and Mental Quality of Life(3, 6, 9 and 12 months from the intervention)
- Burden of HF Symptoms in Patients(3, 6, 9 and 12 months from the intervention)
- Patient and Caregiver Anxiety and Depression(3, 6, 9 and 12 months from the intervention)
- Patient and Caregiver Mutuality(3, 6, 9 and 12 months from the intervention)
- Caregiver Perceived Social Support(3, 6, 9 and 12 months from the intervention)
- Death(3, 6, 9 and 12 months from the intervention)
- Patient Hospitalizations(3, 6, 9 and 12 months from the intervention)
- Use of Emergency Services(3, 6, 9 and 12 months from the intervention)
研究者
Ercole Vellone
Assistant Professor
University of Rome Tor Vergata