Adherence to Palivizumab Prophylaxis

NCT05778240 | Completed

• 1 other identifier: 2020/14/413
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Effectiveness of cognitive biases in increasing adherence to prophylaxis programme

  The average adherence rates in the control and treatment groups

  4 weeks

Secondary Outcomes (17)

• The effect of father employment status (full-time, part-time, no) 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 birth weight (weight in grams) 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 knowledge about respiratory syncytial virus previously (yes/no) on the participants' adherence to the prophylaxis program

  8 weeks

Study Arms (3)

Status quo bias and implementation intention bias

EXPERIMENTAL

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).

Behavioral: Phone call

Availability bias and social norm

EXPERIMENTAL

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).

Behavioral: Text message

Control

EXPERIMENTAL

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

Behavioral: Control

Interventions

Phone call 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?

Status quo bias and implementation intention bias

Text message 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.

Availability bias and social norm

Control BEHAVIORAL

Participants were given the vaccination appointment card.

Control

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kosuyolu Heart Hospital: lead
• Sabanci University: collaborator
• Maras Necip Fazil City Hospital: collaborator
• Kocaeli University: collaborator
• Van Research and Education Hospital: collaborator
• Sakarya University: collaborator
• Sivas Numune Hospital: collaborator

Study Sites (1)

Kosuyolu Heart Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Erolu E, Kibris O, Tosun Y, Yildirim A, Pamukcu O, Basar EZ, Babaoglu K, Epcacan S, Donmez Y, Giray D, Dervisoglu P, Tasci O. Behavioural interventions to increase adherence to palivizumab prophylaxis in children with CHD. Cardiol Young. 2024 Apr 26:1-8. doi: 10.1017/S1047951124024946. Online ahead of print.

  PMID: 38664919 DERIVED

Study Officials

• Elif Erolu, M.D.Ph.D.

  Kosuyolu Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 21, 2023
• Study Start: October 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: June 1, 2021
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)