The Transitioning Rural Adolescents to Adult Care Study

NCT04090827 | Completed

• 1 other identifier: Pro00074194
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Transition; Congenital Heart Defect

Keywords

transition; Congenital heart disease; education; adolescence

Outcome Measures

Primary Outcomes (1)

• adolescents' knowledge of their heart

  Change in MyHeart Scale, between baseline, 1, and 6 months.

  baseline, 1 month, 6 months

Secondary Outcomes (4)

• Self-Efficacy

  baseline, 1 month, 6 months

• Transition Readiness

  baseline, 1 month, 6 months

• iHeartChange Use

  6 months

• Nurse-adolescent Interactions

  6 months

Study Arms (1)

Intervention

EXPERIMENTAL

Nurse-led transition intervention and access to the iHeartChange website

Other: Nurse-led transition intervention and access to the iHeartChange website

Interventions

Nurse-led transition intervention and access to the iHeartChange website OTHER

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

Intervention

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Andrew Mackie, MD

  Stollery Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: September 16, 2019
• Study Start: September 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)