NCT05550922

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

October 4, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2023

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

September 10, 2022

Last Update Submit

March 24, 2023

Conditions

Keywords

AdolescentsTransfer to adult careTransitional careAsthma

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Self Efficacy Scale for Children and Adolescents with Asthma (SESCAA)

    SESCAA score will evaluate at baseline.

  • Self Efficacy Scale for Children and Adolescents with Asthma (SESCAA)

    SESCAA score will evaluate at third month

  • Mind the Gap Scale (MGS)

    MGS score will evaluate at baseline

  • Mind the Gap Scale (MGS)

    MGS score will evaluate at third month

Study Arms (2)

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.

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.

Interventions

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.

Healthcare transition based education

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Not being between the ages of 14-18
  • Another chronic disease
  • Not completing all trainings and follow-ups during the research period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Fatma DİNÇ, PhD Student

    Saglik Bilimleri University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2022

First Posted

September 22, 2022

Study Start

October 4, 2022

Primary Completion

March 7, 2023

Study Completion

March 7, 2023

Last Updated

March 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations