Adherence to Palivizumab Prophylaxis

Congenital Heart Disease in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05778240
• Other study ID #: 2020/14/413
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: March 2023
• Source: Kosuyolu Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: June 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease in Children
• Heart Defects, Congenital
• Heart Diseases
• RSV

Intervention

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?
• 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.
• Control
Participants were given the vaccination appointment card.

Locations

Country	Name	City	State
Turkey	Kosuyolu Heart Hospital	Istanbul

Sponsors (7)

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

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of cognitive biases in increasing adherence to prophylaxis programme	The average adherence rates in the control and treatment groups	4 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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