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The Transitioning Rural Adolescents to Adult Care Study (TRAAC)

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ClinicalTrials.gov Identifier: NCT04090827
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Andrew Mackie, University of Alberta

Tracking Information
First Submitted Date  ICMJE June 26, 2019
First Posted Date  ICMJE September 16, 2019
Last Update Posted Date April 28, 2021
Actual Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Transitioning Rural Adolescents to Adult Care Study
Official Title  ICMJE 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
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.

Detailed Description

PURPOSE:

The Transitioning Rural Adolescents to Adult Care (TRAAC) Study is a mixed-methods randomized controlled trial (RCT) evaluating the impact of a Telehealth-based nurse-led transition intervention in combination with access to a CHD website, versus the CHD website alone, 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, versus iHeartChange alone, on adolescents' self-management skills.

The secondary objectives are to:

(i) evaluate the impact of the nurse-led intervention on adolescents' self-efficacy

(ii) measure iHeartChange use by participants , and

(iii) explore potential influences on intervention effectiveness, using qualitative data.

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 those assigned to the intervention group, 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Transition
  • Congenital Heart Defect
Intervention  ICMJE 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
Study Arms  ICMJE
  • No Intervention: Control/ iheartchange Only
    Access to the iHeartChange website only
  • Experimental: Intervention
    Nurse-led transition intervention and access to the iHeartChange website
    Intervention: Other: Nurse-led transition intervention and access to the iHeartChange website
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alyssa Chappell, RN 7804071327 amc12@ualberta.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04090827
Other Study ID Numbers  ICMJE Pro00074194
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Andrew Mackie, University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew Mackie, MD Stollery Children's Hospital
PRS Account University of Alberta
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP