Clinical trial NCT02374892: The CHAPTER III Study of Young Adolescents
Official title: The CHAPTER III Study of Young Adolescents: Congenital Heart Adolescents Participating in Transition Evaluation Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Defects, Congenital
Keywords: Intervention
Congenital Heart Disease
Adolescent
Education
Self-management
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Women and Children's Health Research Institute (WCHRI)
name: Stollery Children's Hospital Foundation
First posted: 2015-03-02
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: TRANSITION-Q Questionnaires
timeFrame: 6 Months
Secondary outcomes:
measure: MyHeart Scale
timeFrame: 6 Months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Andrew S Mackie, MD, SM
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: Mackie AS, Rankin KN, Yaskina M, Gingrich J, Williams E, Schuh M, Kovacs AH, McCrindle BW, Nicholas D, Rempel GR. Transition Preparation for Young Adolescents with Congenital Heart Disease: A Clinical Trial. J Pediatr. 2022 Feb;241:36-41.e2. doi: 10.1016/j.jpeds.2021.09.053. Epub 2021 Oct 4.