Effectiveness of Self care Intervention Program (SIP) on Self-care Behaviour, Clinical Outcome and Quality of Life among patients with Heart Failure- a Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Self-care behaviour, Clinical outcomes- left ventricular ejection fraction, readmission, functional status, mortality; and Quality of Life
研究概览
简要总结
This study is a randomized controlled trial with a parallel arm to evaluate the effectiveness of the Self-care Intervention Program (SIP) on self-care behaviour, clinical outcomes and quality of life of patients with heart failure attending Medical College Hospital, Thiruvananthapuram, Kerala. Self-care Intervention Program (SIP) includes face -to-face instruction with teach-back method by using video-assisted teaching on various aspects of self-care in heart failure for patients and their caregivers, demonstration of checking body weight, symptom and event diary and a leaflet on self-care. reinforcement will be through an online platform (WhatsApp group) and during subsequent OPD visits. The control group will receive only standard care. The primary outcome measures are self-care behaviour, clinical outcomes (LVEF, readmission, NYHA functional class and mortality) and quality of life. The secondary outcome is medication adherence. Self-care behaviour, NYHA functional class and medication adherence will be measured at baseline, 4 weeks and 12 weeks. LVEF and QoL will be measured at baseline and 12 weeks. Readmission will be measured at 4 weeks and 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with a clinical diagnosis of Heart Failure who are 18 years or above, with reduced ejection fraction (equal to or less than 40%), NYHA functional class II to III, having a smartphone or an android tablet and the knowledge to use these devices or a caregiver who has the knowledge to use these devices, able to read and speak Malayalam language and willing to participate.
排除标准
- •Patients with a clinical diagnosis of Heart Failure who have a documented history of: -coexisting terminal illness (cancer, or primary organ failure- CLD, CKD, interstitial lung disease, stroke).
- •psychiatric illness and dementia.
- •receiving advanced heart failure therapies (VADs/ transplant).
结局指标
主要结局
Self-care behaviour, Clinical outcomes- left ventricular ejection fraction, readmission, functional status, mortality; and Quality of Life
时间窗: Self-care behaviour and NYHA functional class will be measured at baseline, 4 weeks, and 12 weeks. LVEF and QoL will be measured at baseline and 12 weeks. Readmission will be measured at 4 weeks and 12 weeks.
次要结局
- Medication adherence(baseline, 4 weeks, 12 weeks)
研究者
MeeralakshmiG
Government College of Nursing, Government Medical College, Thiruvananthapuram.