- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05550922
The Effect of Health Care Transition Based Education Given to Adolescents With Asthma
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:
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey, 06010
- Gulhane Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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: 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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
TRAQ score will evaluate at baseline
|
|
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.
|
TRAQ score will evaluate at third month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self Efficacy Scale for Children and Adolescents with Asthma (SESCAA)
Time Frame: SESCAA score will evaluate at baseline.
|
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.
|
|
Self Efficacy Scale for Children and Adolescents with Asthma (SESCAA)
Time Frame: SESCAA score will evaluate at third month
|
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
|
|
Mind the Gap Scale (MGS)
Time Frame: MGS score will evaluate at baseline
|
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
|
|
Mind the Gap Scale (MGS)
Time Frame: MGS score will evaluate at third month
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10742606484
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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