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Completed

NCT Number: NCT01723332

The CHAPTER II Study - Congenital Heart Adolescents Participating in Transition Evaluation Research

Transition is the planned movement of teens with chronic conditions from child-centered to adult-oriented healthcare. National bodies have published detailed guidelines about the importance of helping teens move to adult healthcare. However, there is no research regarding how to best organize and deliver Congenital Heart Disease (CHD) transition programs. Data is urgently needed. Therefore, the aim of this program is to develop research evidence that will better prepare health care providers to improve how they can help adolescents with transition.

This project will determine whether a nurse-led transition intervention program is better at preparing teens with CHD to independently manage their medical care, compared to the care that is currently provided. The most important finding of this study will be whether or not these teens subsequently attend the adult cardiology clinic that specializes in CHD problems, and the timing of when they attend.

Hypothesis: A transition intervention in combination with usual care, improved time to first Adult Congenital Heart Disease (ACHD) clinic attendance compared to usual care alone.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

16 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stollery Children's Hospital, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 16 and 17 year olds with moderate or complex CHD

Exclusion criteria

  • Significant developmental delay
  • Previous heart transplantation

Treatment and study plan

Educational

Behavioral

The first interaction will happen at study enrolment and will be educational in nature.

Following the session, the nurse will follow up with the participant to discuss any questions.

Self Management

Behavioral

The second interaction will take place 2 months after enrollment and will focus on self management and communication skills.

Following the session, the nurse will follow up with the participant to discuss any questions.

Primary outcomes

  1. Excess time to first ACHD clinic appointment.

    Time frame: 12 - 24 months post enrolment

Secondary outcomes

  1. Change in adolescent knowledge of their condition.

    Time frame: 6 - 18 months post enrolment

  2. Change in adolescent's self-management and self-advocacy skills/

    Time frame: 6 - 18 months post enrolment

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Heart and Stroke Foundation of Canada

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 7, 2012
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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