The Effect of Structured Transition Care Model Applied to Adolescents With Congenital Heart Disease

NCT06433401 | Recruiting

• 1 other identifier: AnkaraYBU-SBF-TKT-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

Congenital heart disease is one of the most common congenital defects with a high mortality and morbidity rate. Children with congenital heart disease step from pediatric care to adult care during adolescence. This situation has brought up transitional care, which is defined as "the purposeful and planned movement of adolescents and young adults with chronic physical and medical conditions from pediatric to adult-oriented health systems". Since adolescents with congenital heart disease are at high risk for complications in adulthood, it is very important to raise awareness, increase the level of readiness for adult care and gain self-management skills during the transition phase. This study was planned as a randomized controlled experimental study to evaluate the effect of the developmental transition care model applied to adolescents with congenital heart disease during the transition from pediatric care to adult care on the transition readiness level, self-management skills and care satisfaction of adolescents. Studies have shown that both adolescents with congenital heart disease and their caregivers need professional support, appropriate transition education and care before transition to adult care in order to increase adaptation to adult care, to gain self-management skills and to reduce their concerns. Studies in which adolescents are followed up after transition to adult care show that when the transition process is not successfully completed, there is excessive time between the last pediatric control and the first adult control or there are losses in further follow-up. Although there are studies in our country in which transition care is applied, this study is planned because there is no intervention study in which developmental transition care model is applied to adolescents with congenital heart disease. It is thought that this study will increase the transition readiness levels, self-management skills and care satisfaction of adolescents with congenital heart disease and guide the nurses working with them.

Conditions

Congenital Heart Disease in Adolescence

Keywords

Congenital heart disease; Adolescent; Transition care; Nurses

Outcome Measures

Primary Outcomes (1)

• Transition Readiness Assessment Scale

  It addresses the readiness of adolescents/young adults with chronic diseases to transition from pediatric care to adult care with the sub-dimensions of management of treatment, management of appointments, monitoring of health status, communication with health personnel and management of daily activities. The Cronbach alpha internal consistency coefficient of the Turkish scale was .88. The readiness for transition assessment scale is a 5-point Likert-type self-assessment scale to assess the skills and behaviors required for disease management in five sub-dimensions. Each item is evaluated between 1 point (no, I do not know how to do it) and 5 points (yes, I can do it when I need to). Adolescents score a minimum of 20 and a maximum of 100 points. The higher the score obtained from the scale, the higher the level of readiness of the adolescent to transition from pediatric care to adult care.

  at certain intervals for 1 year

Secondary Outcomes (3)

• Data Collection Form on Sociodemographic and Medical Characteristics

  at certain intervals for 1 year

• Chronic Disease Self-Management Scale

  at certain intervals for 1 year

• Transitional Care Satisfaction Rating Scale

  at certain intervals for 1 year

Study Arms (2)

Transition care group

EXPERIMENTAL

The transitional care group is a group that will receive a transitional care training consisting of a total of 3 modules in which the content is arranged for individualized needs with expert opinion from 10 faculty members working in the field of Child Health and Diseases Nursing.The education sessions will be conducted every months in sessions of approximately 35-40 minutes face-to-face in the training room allocated to the individual researcher.

Behavioral: Transitional care training with brochures, posters and slide training materials

Control group

NO INTERVENTION

The control group is the group receiving routine care that continues the normal follow-up of the clinic without any intervention. However, in terms of compliance with ethical principles, the same training will be given to them upon their request after the research is completely completed.

Interventions

Transitional care training with brochures, posters and slide training materials BEHAVIORAL

Education at 1 and 2 months after the first interview

Transition care group

Eligibility Criteria

• Age: 16 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Voluntarily agree to participate in the research
• To be between the ages of 16-20,
• Having a diagnosis of congenital heart disease,
• Being followed up with a diagnosis of congenital heart disease for at least one year in the polyclinics where the study was conducted,
• To be able to communicate in Turkish,
• Not having any mental deficiency that may prevent communication

You may not qualify if:

• Refusing to participate in the research,
• Not being able to communicate in Turkish,
• Not showing up regularly for follow-ups,
• Having any mental disability that may prevent communication

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (2)

Republic of Turkey Ministry of Health Ankara Etlik City Hospital

Ankara, Ankara Yenimahalle, 06170, Turkey (Türkiye)

NOT YET RECRUITING

Republic of Turkey Ministry of Health Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Tutku KIRÇI TEMİZ, PhD s.

  Ankara Yildirim Beyazıt University

  PRINCIPAL INVESTIGATOR

• Evrim KIZILER, Asst.Prof.

  Ankara Yildirim Beyazıt University

  STUDY DIRECTOR

• Utku ARMAN ÖRÜN, Prof.Dr.

  Republic of Turkey Ministry of Health Ankara Etlik City Hospital

  STUDY DIRECTOR

Central Study Contacts

Tutku KIRÇI TEMİZ, PhD s.

CONTACT

+905064278982; tutkukrc29095@gmail.com

Utku ARMAN ÖRÜN, Prof.Dr.

CONTACT

+905322933072; utkuarman.orun@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know which group they are in. They will be assigned to groups by simple simple random randomization method. Since the researcher was the one who provided the training, researcher blinding could not be performed.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study included two groups, an intervention group and a control group. Intervention group receiving transitional care training and control group receiving routine care.

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 29, 2024
• Study Start: August 29, 2024
• Primary Completion: January 30, 2025
• Study Completion: March 30, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)