Clinical trial NCT05778240: Adherence to Palivizumab Prophylaxis
Official title: Behavioral Interventions to Increase Adherence to Palivizumab Prophylaxis in Children With Congenital Heart Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease in Children
RSV
Lead sponsor: Kosuyolu Heart Hospital
Sponsor class: OTHER
Collaborators: name: Sabanci University
name: Maras Necip Fazil City Hospital
name: Kocaeli University
name: Van Research and Education Hospital
name: Sakarya University
name: Sivas Numune Hospital
First posted: 2023-03-21
Enrollment: 229
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness of cognitive biases in increasing adherence to prophylaxis programme
timeFrame: 4 weeks
Secondary outcomes:
measure: The effect of father employment status (full-time, part-time, no) on the participants' adherence to the prophylaxis program
timeFrame: 8 weeks
measure: The effect of number of children in the family on the participants' adherence to the prophylaxis program
timeFrame: 8 weeks
measure: The effect of birth weight (weight in grams) on the participants' adherence to the prophylaxis program
timeFrame: 8 weeks
measure: The effect of number of intensive care unit admissions on the participants' adherence to the prophylaxis program
timeFrame: 8 weeks
measure: The effect of knowledge about respiratory syncytial virus previously (yes/no) on the participants' adherence to the prophylaxis program
timeFrame: 8 weeks
measure: The effect of finding prophylaxis program important or not (yes/no) on the participants' adherence to the prophylaxis program
timeFrame: 8 weeks
measure: The effect of the distance between home and hospital (km) on the participants' adherence to the prophylaxis program
timeFrame: 8 weeks
measure: The effect of number of difficulties about accessing to prophylaxis program on the participants' adherence to the prophylaxis program
timeFrame: 8 weeks
measure: The effect of family size (number of people living in the same house) on the participants' adherence to the prophylaxis program
timeFrame: 8 weeks
measure: The effect of the number of children in the school age on the participants' adherence to the prophylaxis program
timeFrame: 8 weeks
measure: 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
timeFrame: 8 weeks
measure: The effect of smoking (yes/no) on the participants' adherence to the prophylaxis program
timeFrame: 8 weeks
measure: The effect of father and mother's age (years) on the participants' adherence to the prophylaxis program
timeFrame: 8 weeks
measure: The effect of father and mother education level (no education, primary school, high school, university) on the participants' adherence to the prophylaxis program
timeFrame: 8 weeks
measure: The effect of employment status of mother on the participants' adherence to the prophylaxis program
timeFrame: 8 weeks
measure: The effect of marital status (married, married- separated, divorced, widowed) on the participants' adherence to the prophylaxis program
timeFrame: 8 weeks
measure: 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
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kosuyolu Heart Hospital
Study officials:
affiliation: Kosuyolu Heart Hospital
name: Elif Erolu, M.D.Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: