The Effect of Health Care Transition Based Education Given to Adolescents With Asthma

NCT ID: NCT05550922

Last Updated: 2023-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-04

Study Completion Date

2023-03-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma in Children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthcare transition based education

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.

Group Type EXPERIMENTAL

Healthcare Transition-Based Education

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fatma DİNÇ, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gulhane Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38456636 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10742606484

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.