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

NCT01723332 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-11-06

No results posted yet for this study

Summary

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.

Conditions

  • Congenital Heart Disease

Interventions

BEHAVIORAL

Educational

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.

BEHAVIORAL

Self management

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.

Sponsors & Collaborators

  • Heart and Stroke Foundation of Canada

    collaborator OTHER
  • University of Alberta

    lead OTHER

Principal Investigators

  • Andrew S Mackie, MD, SM · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2016-12-01
Completion
2016-12-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01723332 on ClinicalTrials.gov