Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05778240
Other study ID # 2020/14/413
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05975658 - WIReD: Wireless Interstage Remote Device Study
Completed NCT05546983 - How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ?
Completed NCT03229538 - STeroids to REduce Systemic Inflammation After Infant Heart Surgery Phase 3
Completed NCT05579964 - The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot Phase 2/Phase 3
Recruiting NCT05128084 - Amotosalen and Platelet Transfusion in Pediatric Heart Surgery
Recruiting NCT04604418 - Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
Completed NCT04666857 - Family Centred Early Intervention of Infants With Congenital Heart Disease N/A
Terminated NCT03136900 - Impact on the Nitrogen Balance, Autonomy, Safety and Tolerance of Enteral Diets Made of With Nutrilon Without Lactose® Fortified by Concentration Versus by Maltodextrin and Oil Supplementation,After Surgery for Congenital Heart Disease, in Infants. N/A
Recruiting NCT05910320 - Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants N/A
Not yet recruiting NCT05778175 - Common Cases in Pediatric Intensive Care in Assuit University Cardiology Institute, a Clinical Audit
Completed NCT05284500 - Predictive Pre and Peroperative Factors for MODS-2 in Pediatric Cardiac Surgery
Completed NCT04295239 - Non-invasive Monitoring of Cerebral Self-regulation in Perioperative Neonatal Cardiac Surgery N/A
Completed NCT05142046 - Influence of Intraoperative Fluid Balance on the Incidence of Adverse Events in Pediatric Cardiac Surgery
Recruiting NCT04040452 - Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery Phase 4
Not yet recruiting NCT06431269 - Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease N/A
Recruiting NCT05268094 - Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial) N/A
Recruiting NCT04315610 - Personalized Mobile App for Parents of Infants With Cardiac Disease N/A
Completed NCT04018079 - Left Ventricular Dysfunction Post-surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis
Recruiting NCT05496803 - Impact of Systematic Nursing Guidance on the Psychological Effects of Parents of Children With Cardiac Catheterization. N/A
Recruiting NCT05826769 - To Assess the Efficacy of Early Administration of Energy Enriched and Protein Enriched Formula in Post Cardiac Repair Infants: a Randomized Controlled Trial, Comparative Study N/A