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The Transitioning Rural Adolescents to Adult Care Study (TRAAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04090827
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : April 28, 2021
Information provided by (Responsible Party):
Andrew Mackie, University of Alberta

Brief Summary:

Approximately 1 in 10 teenagers lives with a chronic health condition that will require ongoing care as they enter adulthood. Birth defects of the heart, also known as congenital heart disease (CHD) are more common than any other type of birth defect and affect about 1 in 100 children, with most surviving to adulthood. However, most teenagers with CHD have little knowledge about their heart and lack confidence in talking with doctors and nurses about their health. These are essential skills when entering the adult-oriented health care system after graduating from pediatric care.

In the current study proposal our team plans to evaluate the effectiveness of delivering 1-on-1 teaching sessions for adolescents who live in smaller communities and can't easily come to Edmonton for appointments in the heart clinic. Fortunately in Alberta we have a widely available system called Telehealth that allows nurses and teens to meet by private, secure teleconferencing while hundreds of miles away. Telehealth is provided by health clinics around the province. We propose to use Telehealth in adolescents' home communities to provide these teaching sessions for 16-19 year olds with CHD who are soon going to be graduating from pediatric to adult care.

Participants who receive a nurse-led teaching session will be compared with a similar number of adolescents who are not offered a teaching session, using a questionnaire that addresses skills related to taking care of their health condition. This questionnaire will be completed on-line (or if preferred by the participant, by letter mail) 1 month and 6 month after entering the study.

Deciding which adolescents receive a nurse-led teaching session will be random, i.e. like the flip of a coin. Regardless, all participants will receive access to a website for young people with CHD called iHeartChange.

Condition or disease Intervention/treatment Phase
Transition Congenital Heart Defect Other: Nurse-led transition intervention and access to the iHeartChange website Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: To determine "Intervention" vs. "iHeartChange only", a biostatistician will prepare the randomization sequence. Permuted-block randomization with varying block sizes and equal allocation ratio will be used to ensure balanced allocation of patients between the 2 treatment arms. Blocks of sizes 2 and 4 will be randomly mixed to overcome the problem of predicting the allocation for the last few entries in each block. A given cardiologist's patients will be allocated to iHeartChange or the intervention group equally, preventing potential bias by cardiologist co-intervention
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Mixed Methods RCT Evaluating a Telehealth-based Nurse-led Transition Intervention in Combination With Access to a CHD Website, vs. the CHD Website Alone, on Preparing Rural-based Adolescents Living With CHD to Successfully Transition From Pediatric to Adult Cardiology Care
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Control/ iheartchange Only
Access to the iHeartChange website only
Experimental: Intervention
Nurse-led transition intervention and access to the iHeartChange website
Other: Nurse-led transition intervention and access to the iHeartChange website
Elements of the transition interventions include: (i) introduction to transition and its importance, (ii) creation of a MyHealth Passport, (iii) review diagram of participant's cardiac anatomy, (iv) discussion of 3 potential future cardiac complications (v) iHeartChange website (vi) discussion of the concept of "self-management" (vii) discussion and promotion of communication skills by the adolescent with their healthcare team via the GLADD technique (Give, Listen, Ask, Decide, Do) (viii) a "3-sentence summary" about their CHD (ix) ongoing text/email support from RN

Primary Outcome Measures :
  1. Transition Readiness [ Time Frame: baseline, 1 month, 6 months ]
    Change in Transition Q score, between baseline, 1, and 6 months. Transition Q scores range from 0 to 100 with higher scores reflecting better self-management skills.

Secondary Outcome Measures :
  1. Self-Efficacy [ Time Frame: baseline, 1 month, 6 months ]
    Change in General Self-Efficacy (GSE) score between baseline, 1 and 6 months. GSE scores range from 0 to 40 with higher scores reflecting more self-efficacy.

  2. iHeartChange Use [ Time Frame: 6 months ]
    The number of times participants have logged in to iHeartChange, and the number of pages within iHeartChange visited will be compared between the two study groups during the first 6 months post enrolment.

  3. Nurse-adolescent Interactions [ Time Frame: 6 months ]
    Qualitative data will consist of nurse-generated intervention logs and field notes recorded immediately following each session, and follow-up 7-day text messages/emails between study nurse and participants in the intervention group, detailing all nurse-adolescent interactions.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 16-21 year olds with moderate or complex congenital heart disease (CHD), as previously defined
  • Followed in a cardiology satellite/outreach clinic affiliated with the Stollery Children's Hospital (High Level, Fort McMurray, Grand Prairie, Red Deer, Yellowknife)

Exclusion Criteria:

  • less than a Grade 6 level of reading and comprehension, based on medical record review or parent report;
  • heart transplantation, as this results in distinct health challenges.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04090827

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Contact: Alyssa Chappell, RN 7804071327

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Canada, Alberta
Stollery Children's Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Alyssa Chappell, BScN    1 780 407 1327   
Contact: Andrew Mackie, MD    1 780 407 8361   
Sponsors and Collaborators
University of Alberta
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Principal Investigator: Andrew Mackie, MD Stollery Children's Hospital
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Responsible Party: Andrew Mackie, Associate Professor, Pediatric Cardiologist, Principal Investigator, University of Alberta Identifier: NCT04090827    
Other Study ID Numbers: Pro00074194
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrew Mackie, University of Alberta:
Congenital heart disease
Additional relevant MeSH terms:
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Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities