NCT05778240

Adherence to Palivizumab Prophylaxis

Behavioral Interventions to Increase Adherence to Palivizumab Prophylaxis in Children With Congenital Heart Disease: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: Kosuyolu Heart Hospital · Academic / Other
• Sex: All
• Age: 1 Month – 24 Months
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Congenital Heart Disease in Children
• RSV

Interventions

Type	Name	Description
BEHAVIORAL	Phone call	Participants were given the vaccination appointment card and participants received a telephone call every month two days before their appointment. Participants were reminded that they have a set appointment and were asked to plan the day of their appointment as detailed below. The standard script used in the telephone call in every hospital was as follows:Hello, we are calling you because you are enrolled in the palivizumab prophylaxis research program. As you know, you have a vaccination appointment on \[enter date\] at \[enter time\]. To help you plan your day of appointment, we have a few short questions. 1. At your appointment day, will you be coming to the hospital from home, or will you need to get permission from your workplace? 2. What kind of transportation do you plan to take to come to the hospital at your appointment day? 3. At what time do you plan to leave home or work to come to the hospital?
BEHAVIORAL	Text message	Participants were given the vaccination appointment card and participants were included in a messaging group (on Whatsapp or SMS, depending on the participant's preference) where, twice a month they received a message informing them on RSV, on the additional risks caused by RSV infection in children with congenital heart diseases and on the benefits of adherence to the prophylaxis program. These messages also involved statements about the high number of patient families that kept their appointments in the previous month.
BEHAVIORAL	Control	Participants were given the vaccination appointment card.

Timeline

• Start date: 2020-10-01
• Primary completion: 2020-12-31
• Completion: 2021-06-01
• First posted: 2023-03-21
• Last updated: 2023-03-21

Locations

1 site across 1 country: Turkey (Türkiye)