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

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

Sponsors

Lead sponsor: University of Alberta

Collaborator: Heart and Stroke Foundation of Canada

Source University of Alberta
Brief 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.

Overall Status Completed
Start Date November 2012
Completion Date December 1, 2016
Primary Completion Date December 1, 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Excess time to first ACHD clinic appointment. 12 - 24 months post enrolment
Secondary Outcome
Measure Time Frame
Change in adolescent knowledge of their condition. 6 - 18 months post enrolment
Change in adolescent's self-management and self-advocacy skills/ 6 - 18 months post enrolment
Enrollment 120
Condition
Intervention

Intervention type: Behavioral

Intervention name: Educational

Description: 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.

Arm group label: Intervention

Intervention type: Behavioral

Intervention name: Self management

Description: 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.

Arm group label: Intervention

Eligibility

Criteria:

Inclusion Criteria:

- 16 and 17 year olds with moderate or complex CHD

Exclusion Criteria:

- Significant developmental delay

- Previous heart transplantation

Gender: All

Minimum age: 16 Years

Maximum age: 17 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Andrew S Mackie, MD, SM Principal Investigator University of Alberta
Location
facility
Stollery Children's Hospital
Hospital For Sick Children
Location Countries

Canada

Verification Date

October 2017

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Alberta

Investigator full name: Andrew Mackie

Investigator title: Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Intervention

Arm group type: Experimental

Description: Clinical based educational and self management intervention.

Arm group label: Usual Care

Arm group type: No Intervention

Description: 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.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov