The CHAPTER III Study of Young Adolescents

April 24, 2019 updated by: University of Alberta

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Stollery Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention

Adolescents will attend a single one-on-one session with a nurse. Sessions will be youth-oriented, interactive, and engaging. They will make a health passport, go over their cardiac anatomy, watch videos among other things.

The adolescent will be given a study email address and encouraged to contact the nurse by email or text messaging with follow-up.
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
No Intervention: Usual Care
Youth seen in the Cardiology clinic see a nurse only to measure weight, height, and blood pressure. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TRANSITION-Q Questionnaires
Time Frame: 6 Months
Change in TRANSITION-Q Questionnaire score between baseline, 1 month, and 6-months post enrollment.
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MyHeart Scale
Time Frame: 6 Months
Change in knowledge of their heart (MyHeart score) between baseline, 1 month and 6-months post enrollment.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Stollery Children's Hospital Foundation
Women and Children's Health Research Institute (WCHRI)

Investigators

  • Principal Investigator: Andrew S Mackie, MD, SM, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

February 23, 2015

First Submitted That Met QC Criteria

February 27, 2015

First Posted (Estimate)

March 2, 2015

Study Record Updates

Last Update Posted (Actual)

April 25, 2019

Last Update Submitted That Met QC Criteria

April 24, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The CHAPTER III Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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