Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05550922
Other study ID # 10742606484
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 4, 2022
Est. completion date March 7, 2023

Study information

Verified date March 2023
Source Saglik Bilimleri Universitesi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date March 7, 2023
Est. primary completion date March 7, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 18 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Not being between the ages of 14-18 - Another chronic disease - Not completing all trainings and follow-ups during the research period.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Healthcare Transition-Based Education
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.

Locations

Country Name City State
Turkey Gulhane Training and Research Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. TRAQ score will evaluate at baseline
Primary 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. TRAQ score will evaluate at third month
Secondary 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. SESCAA score will evaluate at baseline.
Secondary 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. SESCAA score will evaluate at third month
Secondary 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. MGS score will evaluate at baseline
Secondary 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. MGS score will evaluate at third month
See also
  Status Clinical Trial Phase
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Recruiting NCT05734261 - Forced Oscillations Technique During a Metacholine Test in Children N/A
Recruiting NCT06044051 - Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma N/A
Completed NCT04896502 - Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers N/A
Completed NCT03503812 - Mitigating the Health Effects of Desert Dust Storms Using Exposure-Reduction Approaches N/A
Not yet recruiting NCT05902702 - Isotonic Saline for Children With Bronchiolitis N/A
Not yet recruiting NCT05547477 - Continuous EMG Measurements in Children With Asthma During Sleep
Completed NCT04388098 - Oral Health Status of Asthmatic Children
Terminated NCT03586544 - Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity Phase 4
Recruiting NCT04821908 - Consequences of COVID 19 Pandemic on Childhood Asthma
Not yet recruiting NCT03277170 - Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations Phase 2
Enrolling by invitation NCT06239844 - Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English N/A
Recruiting NCT06003569 - Reducing Asthma Attacks in Disadvantaged School Children With Asthma N/A
Not yet recruiting NCT05974917 - Serious gaMes as Emerging E-health Interventions for Young People With neurologicaL or rEspiratory disoRders
Not yet recruiting NCT05997784 - Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
Recruiting NCT05366309 - Performance and Adherence in Children Using Spacers N/A
Completed NCT05684926 - COVID-19 Pandemic Asthma Child Telerehabilitation Yoga N/A
Recruiting NCT04166344 - A mHealth Intervention to Improve Symptom Control in Children and Adolescents With Difficult-to-control Asthma N/A
Completed NCT03673618 - Soluble Corn Fiber Supplementation for Asthma Phase 2
Completed NCT03907410 - The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial N/A