Adherence to Palivizumab Prophylaxis

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

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).

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease in Children; RSV
• Intervention / Treatment: Behavioral: Phone call; Behavioral: Text message; Behavioral: Control

• Study Type: Interventional
• Enrollment (Actual): 229
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Kosuyolu Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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.; At your appointment day, will you be coming to the hospital from home, or will you need to get permission from your workplace?; What kind of transportation do you plan to take to come to the hospital at your appointment day?; At what time do you plan to leave home or work to come to the hospital?
Experimental: 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).	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.
Experimental: Control; Participants' families in this arm were informed about prophylaxis program and provided a schedule	Behavioral: Control; Participants were given the vaccination appointment card.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of cognitive biases in increasing adherence to prophylaxis programme	The average adherence rates in the control and treatment groups	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of father employment status (full-time, part-time, no) on the participants' adherence to the prophylaxis program	Factor that affects participants' adherence to the prophylaxis program. The interaction of each factor on the treatment effect.	8 weeks
The effect of number of children in the family on the participants' adherence to the prophylaxis program	Factor that affects participants' adherence to the prophylaxis program. The interaction of each factor on the treatment effect.	8 weeks
The effect of birth weight (weight in grams) on the participants' adherence to the prophylaxis program	Factor that affects participants' adherence to the prophylaxis program. The interaction of each factor on the treatment effect.	8 weeks
The effect of number of intensive care unit admissions on the participants' adherence to the prophylaxis program	Factor that affects participants' adherence to the prophylaxis program. The interaction of each factor on the treatment effect.	8 weeks
The effect of knowledge about respiratory syncytial virus previously (yes/no) on the participants' adherence to the prophylaxis program	Factor that affects participants' adherence to the prophylaxis program. The interaction of each factor on the treatment effect.	8 weeks
The effect of finding prophylaxis program important or not (yes/no) on the participants' adherence to the prophylaxis program	Factor that affects participants' adherence to the prophylaxis program. The interaction of each factor on the treatment effect.	8 weeks
The effect of the distance between home and hospital (km) on the participants' adherence to the prophylaxis program	Factor that affects participants' adherence to the prophylaxis program. The interaction of each factor on the treatment effect.	8 weeks
The effect of number of difficulties about accessing to prophylaxis program on the participants' adherence to the prophylaxis program	Factor that affects participants' adherence to the prophylaxis program. The interaction of each factor on the treatment effect.	8 weeks
The effect of family size (number of people living in the same house) on the participants' adherence to the prophylaxis program	Factor that affects participants' adherence to the prophylaxis program. The interaction of each factor on the treatment effect.	8 weeks
The effect of the number of children in the school age on the participants' adherence to the prophylaxis program	Factor that affects participants' adherence to the prophylaxis program. The interaction of each factor on the treatment effect.	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	Factor that affects participants' adherence to the prophylaxis program. The interaction of each factor on the treatment effect.	8 weeks
The effect of smoking (yes/no) on the participants' adherence to the prophylaxis program	Factor that affects participants' adherence to the prophylaxis program. The interaction of each factor on the treatment effect.	8 weeks
The effect of father and mother's age (years) on the participants' adherence to the prophylaxis program	Factor that affects participants' adherence to the prophylaxis program. The interaction of each factor on the treatment effect.	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	Factor that affects participants' adherence to the prophylaxis program. The interaction of each factor on the treatment effect.	8 weeks
The effect of employment status of mother on the participants' adherence to the prophylaxis program	Factor that affects participants' adherence to the prophylaxis program. The interaction of each factor on the treatment effect.	8 weeks
The effect of marital status (married, married- separated, divorced, widowed) on the participants' adherence to the prophylaxis program	Factor that affects participants' adherence to the prophylaxis program. The interaction of each factor on the treatment effect.	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	Factor that affects participants' adherence to the prophylaxis program. The interaction of each factor on the treatment effect.	8 weeks

Collaborators and Investigators

• Sponsor: Kosuyolu Heart Hospital
• Collaborators: Kocaeli University; Sakarya University; Sabanci University; Maras Necip Fazil City Hospital; Van Research and Education Hospital; Sivas Numune Hospital
• Investigators: Principal Investigator: Elif Erolu, M.D.Ph.D., Kosuyolu Heart Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: March 18, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 18, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 2020/14/413

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No