Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04090827 |
| Other study ID # |
Pro00074194 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2019 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
May 2024 |
| Source |
University of Alberta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
PURPOSE:
The Transitioning Rural Adolescents to Adult Care (TRAAC) Study is a prospective cohort study
evaluating the impact of a Telehealth-based nurse-led transition intervention in combination
with access to a CHD website on preparing rural-based adolescents living with congenital
heart disease (CHD) to successfully transition from pediatric to adult cardiology care.
OBJECTIVES:
The primary objective is to determine the impact of a nurse-led transition intervention in
combination with access to the iHeartChange website on adolescents' knowledge of their heart
[Hypothesis: the nurse-led intervention will result in superior CHD knowledge compared to
baseline].
The secondary objectives are to:
(i) evaluate the impact of the nurse-led intervention on adolescents' self-efficacy
[Hypothesis: the nurse-led intervention will result in superior self-efficacy compared to
baseline],
(ii) evaluate the impact of the nurse-led intervention on adolescents' self-management skills
[Hypothesis: the nurse-led intervention will result in superior self-management skills
compared to baseline].
(iii) measure frequency of iHeartChange use by participants
RESEARCH METHOD:
Participants will be recruited through the Stollery Children's Hospital Outreach Pediatric
Cardiology clinics. After discussion with the Research Coordinator, the participant will be
emailed an online consent form, and baseline questionnaires through REDCap as well as an
email from the iHeartChange website after the baseline questionnaires are complete.
At the 1 month and 6 month post enrollment, participants will receive the link to complete
the questionnaire via email. Should they not complete the questionnaire within the first 2
weeks, they will receive reminder emails at 2, 4 and 6 weeks post initial send out. At the
completion of the 1 month and 6 month questionnaires, the participant will receive a small
incentive.
For all participants, a one-on-one telehealth session with the nurse will be set up. The
session will take ~ 1 hour. Prior to the session the participant will receive a mail out
transition package of additional written resources containing a "When You're 18 booklet" with
transition specific information, disease specific information sheets, adolescent mental
health resources, +/- endocarditis information if applicable.
Participant heart history information will be collected as well as demographics by accessing
their paper charts, eClinician, Netcare and Connectcare electronic medical records. Baseline
data we are collecting includes current height, weight, date of birth, cardiac diagnosis,
cardiac surgery and procedure information, medications, cardiology visits and other
information from the cardiology clinic letters.
DATA ANALYSIS:
Each participant will be assigned an alphanumerical code and pseudonym. All qualitative data
(nursing logs, text/email transcripts) will be transcribed, anonymized, and analyzed for
codes, categories and subcategories. The unit of analysis will be the nurse-led session; all
data for each session will be analyzed together to get a sense of what happened, what
influenced what happened, and whether the intervention was successful. Categories will be
given descriptors that use words as close to the data as possible; eventually, categories
will be grouped into main categories. Thematic analysis will be used to define broader
categories of potential influences on intervention effectiveness with the unit of analysis
being the entire set of coded session data.
The results of quantitative analyses will be compared with qualitative results to explore the
extent to which there is agreement. Priority will be given to quantitative data; a nuanced
understanding of what influenced intervention effectiveness will be sought through a process
of integration.
