Behavioral Interventions to Increase Adherence to Palivizumab Prophylaxis in Children With Congenital Heart Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 229
- 试验地点
- 1
- 主要终点
- Effectiveness of cognitive biases in increasing adherence to prophylaxis programme
研究概览
简要总结
The goal of this clinical trial is to analyze implications of two alternative nudge-interventions to increase adherence to palivizumab prophylaxis in children with congenital heart disease. The main questions investigators aim to answer are:
- Are well-established cognitive biases effective in increasing patient families' adherence to the palivizumab prophylaxis program?
- What are the factors that affect families' adherence to the prophylaxis program and whether and how the effects of interventions depend on these factors?
To study these questions investigators planned to utilize four well-established cognitive biases in designing two alternative nudge-interventions and investigators measured the effectiveness of each nudge-intervention against a control group.
Patients were randomly allocated to one control and two treatment groups. In the control group, investigators informed participants about the prophylaxis program and provided a schedule. Patients in the first treatment group were additionally called two days before appointments (status quo bias), and were asked to plan the appointment day (implementation intention). Patients in the second treatment group received biweekly messages informing them about the benefits of the program as well as the current adherence rate (availability bias and social norm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 1 Month 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of congenital heart disease which are hemodynamically unstable, congestive heart failure, diagnosis of congenital heart disease with hemodynamically significant residual defects after corrective heart surgery, cardiomyopathy, pulmonary hypertension
- •Being between 0-2 years of age
排除标准
- •Diagnosis of congenital heart disease in which palivizumab prophylaxis is not needed (the diagnosis of congenital heart diseases which are hemodinamically stable.)
- •Becoming exitus during prophylaxis program
- •Not being between 0-2 years of age
结局指标
主要结局
Effectiveness of cognitive biases in increasing adherence to prophylaxis programme
时间窗: 4 weeks
The average adherence rates in the control and treatment groups
次要结局
- The effect of father employment status (full-time, part-time, no) on the participants' adherence to the prophylaxis program(8 weeks)
- The effect of birth weight (weight in grams) on the participants' adherence to the prophylaxis program(8 weeks)
- The effect of knowledge about respiratory syncytial virus previously (yes/no) on the participants' adherence to the prophylaxis program(8 weeks)
- The effect of the distance between home and hospital (km) on the participants' adherence to the prophylaxis program(8 weeks)
- The effect of number of intensive care unit admissions on the participants' adherence to the prophylaxis program(8 weeks)
- The effect of family size (number of people living in the same house) on the participants' adherence to the prophylaxis program(8 weeks)
- The effect of health status of father and mother (in good health, in moderate health, in bad health) on the participants' adherence to the prophylaxis program(8 weeks)
- The effect of father and mother's age (years) on the participants' adherence to the prophylaxis program(8 weeks)
- The effect of father and mother education level (no education, primary school, high school, university) on the participants' adherence to the prophylaxis program(8 weeks)
- The effect of employment status of mother on the participants' adherence to the prophylaxis program(8 weeks)
- The effect of marital status (married, married- separated, divorced, widowed) on the participants' adherence to the prophylaxis program(8 weeks)
- The effect of number of children in the family on the participants' adherence to the prophylaxis program(8 weeks)
- The effect of finding prophylaxis program important or not (yes/no) on the participants' adherence to the prophylaxis program(8 weeks)
- The effect of number of difficulties about accessing to prophylaxis program on the participants' adherence to the prophylaxis program(8 weeks)
- The effect of the number of children in the school age on the participants' adherence to the prophylaxis program(8 weeks)
- The effect of family income (<1000 TL, 1000-2999 TL, 3000-4999 TL, 5000-6999 TL, 7000-8999 TL, >9000 TL ) on the participants' adherence to the prophylaxis program(8 weeks)
- The effect of smoking (yes/no) on the participants' adherence to the prophylaxis program(8 weeks)
研究者
Elif Erolu
Associate Professor
Kosuyolu Heart Hospital