Congenital Heart Disease in ChildrenNCT05778240
Adherence to Palivizumab Prophylaxis
A study testing Phone call and Text message in people with Congenital Heart Disease in Children and RSV, run by Kosuyolu Heart Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Congenital Heart Disease in Children, RSV
- What is being tested?
- Phone call and Text message
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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).
- Conditions
- Congenital Heart Disease in Children, RSV
- Being tested
- Phone call, Text message, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone callBehavioural
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 messageBehavioural
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.
ControlBehavioural
Participants were given the vaccination appointment card.
| Study group | Role | What they receive |
|---|---|---|
| Status quo bias and implementation intention bias | Experimental | 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). Receives: Behavioral: Phone call |
| Availability bias and social norm | Experimental | 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). Receives: Behavioral: Text message |
| Control | Experimental | Participants' families in this arm were informed about prophylaxis program and provided a schedule Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of cognitive biases in increasing adherence to prophylaxis programme
The average adherence rates in the control and treatment groups
Measured: 4 weeks
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start1 Oct 2020
- Primary completion31 Dec 2020
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart Disease in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kosuyolu Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sabanci University, Maras Necip Fazil City Hospital, Kocaeli University, Van Training and Research Hospital, Sakarya University, Sivas Numune Hospital
- Responsible party
- Principal investigator, Elif Erolu, Kosuyolu Heart Hospital
- Investigators
- Elif Erolu, M.D.Ph.D., Principal investigator, Kosuyolu Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778240
- Sponsor's protocol ID
- 2020/14/413
- Status last verified
- Mar 2023
- First submitted
- 17 Feb 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erolu E, Kibris O, Tosun Y, Yildirim A, Pamukcu O, Basar EZ, Babaoglu K, Epcacan S, Donmez Y, Giray D, Dervisoglu P, Tasci O. Behavioural interventions to increase adherence to palivizumab prophylaxis in children with CHD. Cardiol Young. 2024 Apr 26:1-8. doi: 10.1017/S1047951124024946. Online ahead of print.
PubMed 38664919
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Interventions to Increase Adherence to Palivizumab Prophylaxis in Children With Congenital Heart Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05778240
- Acronym / sponsor ID
- 2020/14/413
- Conditions
- Congenital Heart Disease in Children, RSV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Kosuyolu Heart HospitalUniversity, hospital or other
- Collaborators
- Sabanci University, Maras Necip Fazil City Hospital, Kocaeli University, Van Training and Research Hospital, Sakarya University, Sivas Numune Hospital
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Status quo bias and implementation intention bias | Experimental | Behavioral: Phone callParticipants' 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). |
| Availability bias and social norm | Experimental | Behavioral: Text messageParticipants' 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). |
| Control | Experimental | Behavioral: ControlParticipants' families in this arm were informed about prophylaxis program and provided a schedule |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone callParticipants 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. 1. At your appointment day, will you be coming to the hospital from home, or will you need to get permission from your workplace? 2. What kind of transportation do you plan to take to come to the hospital at your appointment day? 3. At what time do you plan to leave home or work to come to the hospital? | Behavioural | Status quo bias and implementation intention bias |
| Text messageParticipants 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. | Behavioural | Availability bias and social norm |
| ControlParticipants were given the vaccination appointment card. | Behavioural | Control |
Primary outcome
Effectiveness of cognitive biases in increasing adherence to prophylaxis programme
Time frame: 4 weeks
The average adherence rates in the control and treatment groups
17 secondary outcomes
The effect of father employment status (full-time, part-time, no) on the participants' adherence to the prophylaxis program
Time frame: 8 weeks
The effect of number of children in the family on the participants' adherence to the prophylaxis program
Time frame: 8 weeks
The effect of birth weight (weight in grams) on the participants' adherence to the prophylaxis program
Time frame: 8 weeks
The effect of number of intensive care unit admissions on the participants' adherence to the prophylaxis program
Time frame: 8 weeks
The effect of knowledge about respiratory syncytial virus previously (yes/no) on the participants' adherence to the prophylaxis program
Time frame: 8 weeks
The effect of finding prophylaxis program important or not (yes/no) on the participants' adherence to the prophylaxis program
Time frame: 8 weeks
The effect of the distance between home and hospital (km) on the participants' adherence to the prophylaxis program
Time frame: 8 weeks
The effect of number of difficulties about accessing to prophylaxis program on the participants' adherence to the prophylaxis program
Time frame: 8 weeks
The effect of family size (number of people living in the same house) on the participants' adherence to the prophylaxis program
Time frame: 8 weeks
The effect of the number of children in the school age on the participants' adherence to the prophylaxis program
Time frame: 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
Time frame: 8 weeks
The effect of smoking (yes/no) on the participants' adherence to the prophylaxis program
Time frame: 8 weeks
The effect of father and mother's age (years) on the participants' adherence to the prophylaxis program
Time frame: 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
Time frame: 8 weeks
The effect of employment status of mother on the participants' adherence to the prophylaxis program
Time frame: 8 weeks
The effect of marital status (married, married- separated, divorced, widowed) on the participants' adherence to the prophylaxis program
Time frame: 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
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Derived from this study: PubMed 38664919Erolu E, Kibris O, Tosun Y, Yildirim A, Pamukcu O, Basar EZ, Babaoglu K, Epcacan S, Donmez Y, Giray D, Dervisoglu P, Tasci O. Behavioural interventions to increase adherence to palivizumab prophylaxis in children with CHD. Cardiol Young. 2024 Apr 26:1-8. doi: 10.1017/S1047951124024946. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif Erolu, M.D.Ph.D. principal investigator
Kosuyolu Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone call and Text message in people with Congenital Heart Disease in Children and RSV, run by Kosuyolu Heart Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of cognitive biases in increasing adherence to prophylaxis programme (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05778240, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.