Asthma in ChildrenNCT05550922
The Effect of Health Care Transition Based Education Given to Adolescents With Asthma
A study testing Healthcare Transition-Based Education in people with Asthma in Children, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Aim: The purpose of this study was to examine the effect of health care transition-based education on transition readiness and self-efficacy in adolescents (14-18 years) with asthma through a randomized controlled experimental study that integrated the literature, model, and research on the transition from pediatrics… Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Healthcare Transition-Based Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Oct 2022to 7 Mar 2023
- 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Being between the ages of 14-18
- Adolescent and parent's consent to participate in the research
- Completing all trainings and follow-ups during the research period.
- Understanding and speaking Turkish
- Having had an asthma diagnosis for at least a year
- Having no mental deficiency that may prevent communication
- Access to internet and a computer
Who cannot join
- Not being between the ages of 14-18
- Another chronic disease
- Not completing all trainings and follow-ups during the research period.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Training and Research Hospital
Ankara, 06010
About this study
Official title: The Effect of Health Care Transition Based Education Program Given to Asthmatic Adolescents on Transition Readiness and Self-Efficacy
Aim: The purpose of this study was to examine the effect of health care transition-based education on transition readiness and self-efficacy in adolescents (14-18 years) with asthma through a randomized controlled experimental study that integrated the literature, model, and research on the transition from pediatrics to adult care.
The research hypotheses are as follows:
Read more
H0: There is no significant difference between the intervention and control groups' mean "Transition Readiness Assessment Questionnaire", "Self Efficacy Scale for Children and Adolescents with Asthma" and "Mind the Gap Scale" scores before and after the education they received on health care transition.
H1: The mean "Transition Readiness Assessment Questionnaire", "Self Efficacy Scale for Children and Adolescents with Asthma" and "Mind the Gap Scale" score of the treatment group is significantly higher than the control group after the education they received on health care transition.
Read the detailed description
Asthma is one of the most prevalent chronic inflammatory diseases in children, negatively impacting more than 7.5% of those under the age of 18. Data indicate that more than half of children with asthma have asthma management failures, resulting in increased healthcare use. Because childhood asthma is a risk factor for the development of chronic obstructive pulmonary disease later in life, it is critical to keep adolescents on track even if their asthma is mild. Furthermore, despite adolescent remission, asthma can resurface in adulthood. As a result, it is critical to identify the factors influencing the transition from pediatric to adult services and to plan for an appropriate transition. Adolescents are expected to be capable of self-management in their own lives and to be willing to accept responsibility for their own health. However, the disparities in care and approach difference between pediatric and adult services increase adolescent resistance to adult care. Following the transition, many difficulties can arise, including changing the adult doctor, failing to attend regular check-ups, discontinuing medication, increasing the use of emergency rooms, and increasing the cost of care. Furthermore, parents become concerned that their children will be unable to care for themselves during the transition to adult service. Health care transition is the deliberate and planned transfer of chronically diagnosed adolescents and young adults' physical and medical conditions from pediatrics-centered care to the adult health care system. Comprehensive planning and information are essential for reducing their anxiety and uncertainty about the transition. The purpose of this study was to examine the effect of health care transition-based education on transition readiness and self-efficacy in adolescents (14-18 years) with asthma through a randomized controlled experimental study that integrated the literature, model, and research on the transition from pediatrics to adult care. The number of children in the groups will be analyzed based on another study in which one of the scales to be used in the study. According to the calculations made in the G-Power 3.1 Demo package program, when the effect size is accepted as 0.75, it was seen that at least 23 cases in each group would be sufficient for 90% power. Because of the possibility of data loss among the participants, it was planned to recruit a total of 60 adolescents. Following the study, power analysis was carried out using the GPOWER 3.1.7 statistical analysis software. The intervention group: Adolescents with asthma will receive one-on-one training on transitioning from the pediatric to adult care, as well as on asthma self-management skills. After retrieving the written consent from the parents and the adolescents, the trainings will be held every two weeks for a total of six sessions over Zoom for three months. Following each training session, four face-to-face individual interviews will be held in a hospital quiet room. Individual interviews at the hospital have been scheduled to last 30 to 40 minutes, with one-on-one training sessions lasting an average of 40 minutes. The adolescent and parent will receive reminder messages the day before the training sessions and the face-to-face meeting. Not all control group participants will receive health care transition-based training. The control group will receive standard outpatient clinic asthma treatment during this process. Following the completion of the study, a training booklet will be distributed to the children in the control group in a way that does not affect the study data.
- Conditions
- Asthma in Children
- Being tested
- Healthcare Transition-Based Education
- Keywords
- Adolescents, Transfer to adult care, Transitional care, Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthcare Transition-Based EducationBehavioural
The goal is for asthmatic adolescents to take responsibility for their own disease, be prepared for transition to adult pulmonology services, increase their self-efficacy, and gain management skills as a result of health care transition education.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare transition based education | Experimental | The content of the education program and interviews include: the importance of transition readiness from pediatric to adult care; asthma, asthma management, asthma support groups and literature; asthma self-management skills (making appointments, taking medications regularly, knowing the risks and what to do during an asthma attack, visiting doctors alone, getting a prescription, communicating with health care professionals); filling out medical forms; insurance; decision making, autonomy, career plans; characteristics of adolescence; pediatrics and adult care differences; transition planning; discussions on case studies; knowledge and skills related to adult pulmonology service procedures; interview with pediatric and adult pulmonologists. Receives: Behavioral: Healthcare Transition-Based Education |
| No Intervention | No intervention | Control: Not all control group participants will receive health care transition-based training. The control group will receive standard outpatient clinic asthma treatment during this process. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Transition Readiness Assessment Questionnaire (TRAQ)
The Transition Readiness Assessment Questionnaire contains a series of questions in which the youth is asked to describe their ability level in various skill areas related to their health and health care, using the following scale: No, I do not know how No, but I want to learn No, but I am learning to do this Yes, I have started doing this Yes, I always do this when I need to. The 1 to 5 likert type scale consists of 20 questions. This produces a minimum score 20, max score 100. A higher score indicates a better outcome.
Measured: TRAQ score will evaluate at baseline
The Transition Readiness Assessment Questionnaire (TRAQ)
The Transition Readiness Assessment Questionnaire contains a series of questions in which the youth is asked to describe their ability level in various skill areas related to their health and health care, using the following scale: No, I do not know how No, but I want to learn No, but I am learning to do this Yes, I have started doing this Yes, I always do this when I need to. The 1 to 5 likert type scale consists of 20 questions. This produces a minimum score 20, max score 100. A higher score indicates a better outcome.
Measured: TRAQ score will evaluate at third month
Secondary outcomes (4)
Self Efficacy Scale for Children and Adolescents with Asthma (SESCAA)
This scale is divided into three sub-dimensions: asthma-related medical knowledge, asthma management skills, and problem-solving skills. This scale was developed to assess how adolescents and children with asthma make decisions and manage their condition. The 1 to 5 likert type scale consists of 22 questions. Score is 22-110, a higher score indicates a better outcome.
Measured: SESCAA score will evaluate at baseline.
Self Efficacy Scale for Children and Adolescents with Asthma (SESCAA)
This scale is divided into three sub-dimensions: asthma-related medical knowledge, asthma management skills, and problem-solving skills. This scale was developed to assess how adolescents and children with asthma make decisions and manage their condition. The 1 to 5 likert type scale consists of 22 questions. Score is 22-110, a higher score indicates a better outcome.
Measured: SESCAA score will evaluate at third month
Mind the Gap Scale (MGS)
Mind the Gap Scale enables adolescents with chronic diseases to self-evaluate the care they receive and set their own expectations; considers the care provided in terms of "physical environment management", "health personnel characteristics" and "care process"; It is a short scale that is simple to use. It is based on the theory of contradiction, which explains the gap between one's ideals, expectations, and what they actually perceive. Based on this, the difference between the adolescent's expectation of "ideal care" and his or her opinions about current care reflects the patient's level of satisfaction. If the adolescents' views on current care are lower than the "ideal care" scores, they are dissatisfied with the care they are receiving. The 1 to 7 Likert type scale consists of 21 questions. The level of satisfaction decreases as the difference in scores obtained from the scale increases.
Measured: MGS score will evaluate at baseline
Mind the Gap Scale (MGS)
Mind the Gap Scale enables adolescents with chronic diseases to self-evaluate the care they receive and set their own expectations; considers the care provided in terms of "physical environment management", "health personnel characteristics" and "care process"; It is a short scale that is simple to use. It is based on the theory of contradiction, which explains the gap between one's ideals, expectations, and what they actually perceive. Based on this, the difference between the adolescent's expectation of "ideal care" and his or her opinions about current care reflects the patient's level of satisfaction. If the adolescents' views on current care are lower than the "ideal care" scores, they are dissatisfied with the care they are receiving. The 1 to 7 Likert type scale consists of 21 questions. The level of satisfaction decreases as the difference in scores obtained from the scale increases.
Measured: MGS score will evaluate at third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start4 Oct 2022
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
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 Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatma DİNÇ, PhD Student, Principal investigator, Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550922
- Sponsor's protocol ID
- 10742606484
- Status last verified
- Mar 2023
- First submitted
- 10 Sep 2022
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dinc F, Yildiz D, Ercan N. The effectiveness of an education program based on healthcare transition in adolescents with asthma: A randomized controlled trial. Pediatr Allergy Immunol. 2024 Mar;35(3):e14101. doi: 10.1111/pai.14101.
PubMed 38456636
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Care Transition Based Education Program Given to Asthmatic Adolescents on Transition Readiness and Self-Efficacy
- ClinicalTrials.gov ID
- NCT05550922
- Acronym / sponsor ID
- 10742606484
- Conditions
- Asthma in Children
- Keywords
- Adolescents, Transfer to adult care, Transitional care, Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 22 Sep 2022 (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.
Aim: The purpose of this study was to examine the effect of health care transition-based education on transition readiness and self-efficacy in adolescents (14-18 years) with asthma through a randomized controlled experimental study that integrated the literature, model, and research on the transition from pediatrics to adult care.
The research hypotheses are as follows:
H0: There is no significant difference between the intervention and control groups' mean "Transition Readiness Assessment Questionnaire", "Self Efficacy Scale for Children and Adolescents with Asthma" and "Mind the Gap Scale" scores before and after the education they received on health care transition.
H1: The mean "Transition Readiness Assessment Questionnaire", "Self Efficacy Scale for Children and Adolescents with Asthma" and "Mind the Gap Scale" score of the treatment group is significantly higher than the control group after the education they received on health care transition.
Detailed description
Asthma is one of the most prevalent chronic inflammatory diseases in children, negatively impacting more than 7.5% of those under the age of 18. Data indicate that more than half of children with asthma have asthma management failures, resulting in increased healthcare use. Because childhood asthma is a risk factor for the development of chronic obstructive pulmonary disease later in life, it is critical to keep adolescents on track even if their asthma is mild. Furthermore, despite adolescent remission, asthma can resurface in adulthood. As a result, it is critical to identify the factors influencing the transition from pediatric to adult services and to plan for an appropriate transition. Adolescents are expected to be capable of self-management in their own lives and to be willing to accept responsibility for their own health. However, the disparities in care and approach difference between pediatric and adult services increase adolescent resistance to adult care. Following the transition, many difficulties can arise, including changing the adult doctor, failing to attend regular check-ups, discontinuing medication, increasing the use of emergency rooms, and increasing the cost of care. Furthermore, parents become concerned that their children will be unable to care for themselves during the transition to adult service. Health care transition is the deliberate and planned transfer of chronically diagnosed adolescents and young adults' physical and medical conditions from pediatrics-centered care to the adult health care system. Comprehensive planning and information are essential for reducing their anxiety and uncertainty about the transition. The purpose of this study was to examine the effect of health care transition-based education on transition readiness and self-efficacy in adolescents (14-18 years) with asthma through a randomized controlled experimental study that integrated the literature, model, and research on the transition from pediatrics to adult care. The number of children in the groups will be analyzed based on another study in which one of the scales to be used in the study. According to the calculations made in the G-Power 3.1 Demo package program, when the effect size is accepted as 0.75, it was seen that at least 23 cases in each group would be sufficient for 90% power. Because of the possibility of data loss among the participants, it was planned to recruit a total of 60 adolescents. Following the study, power analysis was carried out using the GPOWER 3.1.7 statistical analysis software. The intervention group: Adolescents with asthma will receive one-on-one training on transitioning from the pediatric to adult care, as well as on asthma self-management skills. After retrieving the written consent from the parents and the adolescents, the trainings will be held every two weeks for a total of six sessions over Zoom for three months. Following each training session, four face-to-face individual interviews will be held in a hospital quiet room. Individual interviews at the hospital have been scheduled to last 30 to 40 minutes, with one-on-one training sessions lasting an average of 40 minutes. The adolescent and parent will receive reminder messages the day before the training sessions and the face-to-face meeting. Not all control group participants will receive health care transition-based training. The control group will receive standard outpatient clinic asthma treatment during this process. Following the completion of the study, a training booklet will be distributed to the children in the control group in a way that does not affect the study data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthcare transition based education | Experimental | Behavioral: Healthcare Transition-Based EducationThe content of the education program and interviews include: the importance of transition readiness from pediatric to adult care; asthma, asthma management, asthma support groups and literature; asthma self-management skills (making appointments, taking medications regularly, knowing the risks and what to do during an asthma attack, visiting doctors alone, getting a prescription, communicating with health care professionals); filling out medical forms; insurance; decision making, autonomy, career plans; characteristics of adolescence; pediatrics and adult care differences; transition planning; discussions on case studies; knowledge and skills related to adult pulmonology service procedures; interview with pediatric and adult pulmonologists. |
| No Intervention | No intervention | –Control: Not all control group participants will receive health care transition-based training. The control group will receive standard outpatient clinic asthma treatment during this process. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Being between the ages of 14-18
- Adolescent and parent's consent to participate in the research
- Completing all trainings and follow-ups during the research period.
- Understanding and speaking Turkish
- Having had an asthma diagnosis for at least a year
Key exclusion criteria (3 listed)
- Not being between the ages of 14-18
- Another chronic disease
- Not completing all trainings and follow-ups during the research period.
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 |
|---|---|---|
| Healthcare Transition-Based EducationThe goal is for asthmatic adolescents to take responsibility for their own disease, be prepared for transition to adult pulmonology services, increase their self-efficacy, and gain management skills as a result of health care transition education. | Behavioural | Healthcare transition based education |
Primary outcome
The Transition Readiness Assessment Questionnaire (TRAQ)
Time frame: TRAQ score will evaluate at baseline
The Transition Readiness Assessment Questionnaire contains a series of questions in which the youth is asked to describe their ability level in various skill areas related to their health and health care, using the following scale: No, I do not know how No, but I want to learn No, but I am learning to do this Yes, I have started doing this Yes, I always do this when I need to. The 1 to 5 likert type scale consists of 20 questions. This produces a minimum score 20, max score 100. A higher score indicates a better outcome.
The Transition Readiness Assessment Questionnaire (TRAQ)
Time frame: TRAQ score will evaluate at third month
The Transition Readiness Assessment Questionnaire contains a series of questions in which the youth is asked to describe their ability level in various skill areas related to their health and health care, using the following scale: No, I do not know how No, but I want to learn No, but I am learning to do this Yes, I have started doing this Yes, I always do this when I need to. The 1 to 5 likert type scale consists of 20 questions. This produces a minimum score 20, max score 100. A higher score indicates a better outcome.
4 secondary outcomes
Self Efficacy Scale for Children and Adolescents with Asthma (SESCAA)
Time frame: SESCAA score will evaluate at baseline.
Self Efficacy Scale for Children and Adolescents with Asthma (SESCAA)
Time frame: SESCAA score will evaluate at third month
Mind the Gap Scale (MGS)
Time frame: MGS score will evaluate at baseline
Mind the Gap Scale (MGS)
Time frame: MGS score will evaluate at third month
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 27 Mar 2023.
- Derived from this study: PubMed 38456636Dinc F, Yildiz D, Ercan N. The effectiveness of an education program based on healthcare transition in adolescents with asthma: A randomized controlled trial. Pediatr Allergy Immunol. 2024 Mar;35(3):e14101. doi: 10.1111/pai.14101.
- 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.
Fatma DİNÇ, PhD Student principal investigator
Saglik Bilimleri University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthcare Transition-Based Education in people with Asthma in Children, run by Saglik Bilimleri Universitesi 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 7 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 27 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?
The Transition Readiness Assessment Questionnaire (TRAQ) (time frame: TRAQ score will evaluate at baseline). The study lists 2 primary outcomes in all. 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 NCT05550922, 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 27 Mar 2023.