Adherence to Palivizumab Prophylaxis

Kosuyolu Heart Hospital

Status: Completed

Conditions: RSV; Congenital Heart Disease in Children

Treatments: Behavioral: Text message; Behavioral: Phone call; Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05778240

2020/14/413

Details and patient eligibility

About

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).

Enrollment: 229 patients

Sex: All

Ages: 1 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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229 participants in 3 patient groups

Status quo bias and implementation intention bias

Experimental group

Description:

Participants' families in this arm were informed about prophylaxis program and provided a schedule additionally called two days before appointments (status quo bias) and were asked to plan the appointment day (implementation intention).

Treatment:

Behavioral: Phone call

Availability bias and social norm

Experimental group

Description:

Participants' families in this arm were informed about prophylaxis program and provided a schedule and were received messages biweekly informing about benefits of program and adherence rate (availability bias and social norm).

Treatment:

Behavioral: Text message

Control

Experimental group

Description:

Participants' families in this arm were informed about prophylaxis program and provided a schedule

Treatment:

Behavioral: Control