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.|
|ClinicalTrials.gov Identifier: NCT04090827|
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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)|
|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|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
No Intervention: Control/ iheartchange Only
Access to the iHeartChange website only
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
- 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.
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT04090827
|Contact: Alyssa Chappell, RNemail@example.com|
|Principal Investigator:||Andrew Mackie, MD||Stollery Children's Hospital|