TransitionTRAACNCT04090827
The Transitioning Rural Adolescents to Adult Care Study
A study testing Nurse-led transition intervention and access to the iHeartChange website in people with Transition and Congenital Heart Defect, run by University of Alberta at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Transition, Congenital Heart Defect
- What is being tested?
- Nurse-led transition intervention and access to the iHeartChange website
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 16-25 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the detailed 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.
- Conditions
- Transition, Congenital Heart Defect
- Being tested
- Nurse-led transition intervention and access to the iHeartChange website
- Keywords
- transition, Congenital heart disease, education, adolescence
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led transition intervention and access to the iHeartChange websiteOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Nurse-led transition intervention and access to the iHeartChange website Receives: Other: Nurse-led transition intervention and access to the iHeartChange website |
What is being measured
The primary outcome is the main question the study is designed to answer.
adolescents' knowledge of their heart
Change in MyHeart Scale, between baseline, 1, and 6 months.
Measured: baseline, 1 month, 6 months
Secondary outcomes (4)
Self-Efficacy
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.
Measured: baseline, 1 month, 6 months
Transition Readiness
Change in Transition Q score between baseline, 1 and 6 months.
Measured: baseline, 1 month, 6 months
iHeartChange Use
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.
Measured: 6 months
Nurse-adolescent Interactions
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start1 Sep 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransitionStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Mackie, MD, Principal investigator, Stollery Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090827
- Sponsor's protocol ID
- Pro00074194
- Acronym
- TRAAC
- Status last verified
- May 2024
- First submitted
- 26 Jun 2019
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04090827
- Acronym / sponsor ID
- TRAAC / Pro00074194
- Conditions
- Transition, Congenital Heart Defect
- Keywords
- transition, Congenital heart disease, education, adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Nurse-led transition intervention and access to the iHeartChange websiteNurse-led transition intervention and access to the iHeartChange website |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 16-25 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led transition intervention and access to the iHeartChange websiteElements 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 | Other | Intervention |
Primary outcome
adolescents' knowledge of their heart
Time frame: baseline, 1 month, 6 months
Change in MyHeart Scale, between baseline, 1, and 6 months.
4 secondary outcomes
Self-Efficacy
Time frame: baseline, 1 month, 6 months
Transition Readiness
Time frame: baseline, 1 month, 6 months
iHeartChange Use
Time frame: 6 months
Nurse-adolescent Interactions
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Mackie, MD principal investigator
Stollery Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led transition intervention and access to the iHeartChange website in people with Transition and Congenital Heart Defect, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adolescents' knowledge of their heart (time frame: baseline, 1 month, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.