Adherence to Palivizumab Prophylaxis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-06-01

Brief Summary

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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).

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Detailed Description

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Conditions

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Congenital Heart Disease in Children RSV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Status quo bias and implementation intention bias

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).

Group Type EXPERIMENTAL

Phone call

Intervention Type BEHAVIORAL

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?

Availability bias and social norm

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).

Group Type EXPERIMENTAL

Text message

Intervention Type BEHAVIORAL

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.

Control

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

Group Type EXPERIMENTAL

Control

Intervention Type BEHAVIORAL

Participants were given the vaccination appointment card.

Interventions

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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?

Intervention Type 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.

Intervention Type BEHAVIORAL

Control

Participants were given the vaccination appointment card.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No