The CHAPTER III Study of Young Adolescents

Heart Defects, Congenital Clinical Trial

Official title:

The CHAPTER III Study of Young Adolescents: Congenital Heart Adolescents Participating in Transition Evaluation Research

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374892
• Other study ID #: The CHAPTER III Study
• Status: Completed
• Phase: N/A
• Start date: March 1, 2015
• Est. completion date: December 2018

Study information

• Verified date: April 2019
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The CHAPTER III Study (Congenital Heart Adolescents Participating in Transition Evaluation Research) is a cluster randomized controlled trial evaluating the impact of a nurse-led transition intervention in combination with usual care, versus usual care alone, on preparing adolescents with congenital heart disease (CHD) to successfully transition from pediatric to adult cardiology care. The Canadian Pediatric Society and American Academy of Pediatrics have recommended that transition interventions begin in early adolescence. Therefore, the investigators propose to conduct a nurse-led intervention that addresses the educational needs of 13-14 year olds.

Description:

BACKGROUND:

The numbers of youth and young adults with congenital heart disease (CHD) is rapidly increasing, yet youth, parents, and health care providers (HCPs) are unprepared to manage the health care transition from pediatric to adult cardiology care. Both youth and parents report significant anxiety regarding the transition process. When transition is not managed well, youth may not engage with adult HCPs,which may lead to late detection of new problems,excess morbidity, and diminished quality of life.This speaks to the urgency of addressing clinical and health services research gaps, which leave affected youth, families, HCPs, and policy makers with insufficient evidence for transition program delivery.

OBJECTIVE:

The primary aim is to determine the impact of a nurse-led transition intervention in combination with usual care, compared to usual care alone, on self-management and self-advocacy skills among 13-14 year olds with moderate or complex CHD using a validated instrument. [Hypothesis: the transition intervention will result in superior self-management and self-advocacy skills compared to usual care alone]. The secondary aim is to determine knowledge of their CHD lesion [Hypothesis: the transition intervention will result in superior knowledge of the CHD lesion compared to usual care alone].

METHODS:

Study Participants

Inclusion criteria: 13-14 year olds with moderate or complex CHD (as previously defined)who are followed at the Stollery Children's Hospital (Edmonton).

Exclusion criteria: (i) less than a Grade 6 level of reading and comprehension, based on parent report; (ii) heart transplantation, as this results in distinct health challenges.

STUDY DESIGN:

Subjects will be randomized by clusters defined by week of attendance in the pediatric cardiology clinic. Because week is the unit of randomization and not the study subject, this is a cluster randomization design. We anticipate 1-2 subjects per week will be enrolled per site, i.e. the cluster size will be ≤ 2.

INTERVENTIONS:

This intervention will be conducted by a cardiology nurse who is experienced working with teens and will a one-on-one sessions approximately 60 minutes in length. Sessions will be youth-oriented, interactive, and engaging. This session will be held in conjunction with a scheduled pediatric cardiology clinic visit. This timing minimizes the study burden and is consistent with Canadian Pediatric Society recommendations that transition interventions be delivered in clinical settings. Individual sessions, in contrast to group sessions, allow the intervention content to be patient-specific. Immediately prior to the session, the RN will review the cardiology chart to familiarize them self with the cardiac history including cardiac diagnoses, names and dates of cardiac surgical procedures and cardiac catheterizations, and current cardiac medications and doses.

The one-on-one session will combine Education and an introduction of Self-Management. It will involve an introduction to transition and its importance, a discussion of confidentiality to promote trust with the RN, the creation of a MyHealth passport, review of diagram illustrating the teen's cardiac anatomy, the introduction to websites of the Sick Kids Good2Go program, and the youth-oriented YoungAndHealthy, the introduce youth-friendly written materials about risk-taking behaviours, a review of videos of good and bad interactions with a health care provider and encouragement to contact the RN at a study email address or by text messaging with follow-up questions..

STUDY PROCEDURE:

Potential study participants will be approached in the Stollery Children's Hospital Cardiology clinic. A trained project coordinator will approach subjects on both "intervention" days and "usual care" days. The nature and purpose of the study will be explained and informed consent sought from the teen's parent(s)/guardian(s).

MEASURES:

1. The TRANSITION-Q score is a Canadian created, generic self-management skills scale for use with adolescents diagnosed with a chronic health condition who are aged 12 to 18 years. The content of the scale was designed to include a range of skills that vary from those that even young adolescents should be able to do (e.g. answer a doctor's or nurse's questions) to skills that may require instruction or training (e.g. book an appointment).consists of a knowledge scale and behavior index that reports on the youths health and self-care related knowledge and behavior.

2. Knowledge of the cardiac condition will be measured with the MyHeart Scale.

3. Chart review: Descriptive data collected from the cardiology chart will be: date of birth, CHD diagnosis, names and dates of cardiac surgical procedures and cardiac catheterizations, current use of cardiac medications (Y/N), history of missed appointments (Y/N), and cardiologist's name.

Youth will complete the MyHeart Scale and the TRANSITION-Q Questionnaire in the clinic area at enrollment for the "usual care" group, and prior to intervention for the "intervention" group. Both groups will repeat the questionnaires 1 month and 6 months post enrollment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 14 Years

Eligibility

Inclusion Criteria:

(i) moderate or complex CHD (as defined by the 2001 Bethesda Guidelines) (ii) followed at the Stollery Children's Hospital

Exclusion Criteria:

(i) less than a Grade 6 level of reading and comprehension, based on parent report (ii) heart transplantation, as this results in distinct health challenges

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital

Intervention

Behavioral:
• CHAPTER III Study Intervention
This will involve a 60 minute interaction between the adolescent and a cardiology nurse. A MyHealth passport will be created covering the name of the adolescents' cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications will be discussed. The adolescent and nurse will watch videos on talking to various health professionals. The adolescent will be given a study email address and encouraged to contact the nurse by email or text messaging with follow-up

Locations

Country	Name	City	State
Canada	Stollery Children's Hospital	Edmonton	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Alberta	Stollery Children's Hospital Foundation, Women and Children's Health Research Institute (WCHRI)

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Klassen AF, Grant C, Barr R, Brill H, Kraus de Camargo O, Ronen GM, Samaan MC, Mondal T, Cano SJ, Schlatman A, Tsangaris E, Athale U, Wickert N, Gorter JW. Development and validation of a generic scale for use in transition programmes to measure self-management skills in adolescents with chronic health conditions: the TRANSITION-Q. Child Care Health Dev. 2015 Jul;41(4):547-58. doi: 10.1111/cch.12207. Epub 2014 Oct 28. — View Citation

Mackie AS, Islam S, Magill-Evans J, Rankin KN, Robert C, Schuh M, Nicholas D, Vonder Muhll I, McCrindle BW, Yasui Y, Rempel GR. Healthcare transition for youth with heart disease: a clinical trial. Heart. 2014 Jul;100(14):1113-8. doi: 10.1136/heartjnl-2014-305748. Epub 2014 May 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TRANSITION-Q Questionnaires	Change in TRANSITION-Q Questionnaire score between baseline, 1 month, and 6-months post enrollment.	6 Months
Secondary	MyHeart Scale	Change in knowledge of their heart (MyHeart score) between baseline, 1 month and 6-months post enrollment.	6 Months