Adherence to Palivizumab Prophylaxis

Sponsor

Kosuyolu Heart Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05778240

Collaborator

Sabanci University (Other), Maras Necip Fazil City Hospital (Other), Kocaeli University (Other), Van Research and Education Hospital (Other), Sakarya University (Other), Sivas Numune Hospital (Other)

229

Enrollment

Location

Arms

Actual Duration (Months)

28.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease in Children RSV	Behavioral: Phone call Behavioral: Text message Behavioral: Control	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

229 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Jun 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Effectiveness of cognitive biases in increasing adherence to prophylaxis programme [4 weeks]
The average adherence rates in the control and treatment groups

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 24 Months

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kosuyolu Heart Hospital	Istanbul		Turkey

Sponsors and Collaborators

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

Investigators

Principal Investigator: Elif Erolu, M.D.Ph.D., Kosuyolu Heart Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elif Erolu, Associate Professor, Kosuyolu Heart Hospital

ClinicalTrials.gov Identifier:

NCT05778240

Other Study ID Numbers:

2020/14/413

First Posted:

Mar 21, 2023

Last Update Posted:

Mar 21, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Diseases

Heart Defects, Congenital

Study Results

No Results Posted as of Mar 21, 2023