Congenital Heart Defects
Conditions
Keywords
Health Care Transition, Adolescent
Brief summary
The objective of this study is to evaluate the potential role of a cardiology clinic-based educational intervention for 15 to 17 year olds with congenital heart disease (CHD) and their parents, and to determine whether this intervention results in improved self-management skills (e.g., renewing medication prescriptions), teens having greater knowledge of their heart condition, and more teen and parent satisfaction with services. The results of this study will form the basis for a website that in turn may serve as an additional means of providing transition interventions. The results of this study may also be applicable to youth with other special health care needs.
Interventions
BEHAVIORALClinic-based Educational Intervention
This will involve a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport will be created covering the name of the teen's cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications and contact names and location of local adult CHD cardiologists will also be reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) will be presented to the teen who will be asked what advice he/she would offer to the teen in each of those scenarios. The teen will be given a study email address and encouraged to contact the APN by email or text messaging with follow-up questions. If no contact is initiated after 1 week, the APN will email or text (based on preference) the youth, to discuss additional questions.
Sponsors
Women and Children's Health Research Institute, Canada
Stollery Children's Hospital Foundation
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
15 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age 15-17 * Followed in the Stollery Pediatric Cardiology Clinic or the Northern Alberta Adult Congenital (NAACH) clinic * Moderate or Complex Congenital Heart Disease (as defined by the 2001 Bethesda guidelines) or Acquired Heart Disease (cardiomyopathy (dilated, hypertrophic, or restrictive forms), Marfan's syndrome or rheumatic heart disease with cardiac involvement)
Exclusion criteria
* Developmental Delay, reading level below grade 6 based on patient or parent report
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transition Readiness Assessment Questionnaire (TRAQ) Score | Baseline, 1 month and 6 months | The TRAQ is the most rigorously evaluated transition readiness questionnaire available and was developed in the USA. It has 29 items with two domains, self-management (16 items) and self-advocacy (13 ). The TRAQ is at a grade 5.7 reading level and uses a Likert scale. Each item is scored 1-5, with 1 being assigned for responses of No, I do not know how and a score of 5 assigned for responses of Yes, I always do this when I need to. The TRAQ scores produced include an overall score and a subscale score. The overall score and the subscale scores are calculated simply by taking the average score across the items in the questionnaire (or subscale). The higher the score, the greater the perceived self-management or self-advocacy skills of the participant. The lower scores indicate the participant has a lower perceived level of self-management or self-advocacy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MyHeart Score | Baseline, 1 month and 6 months | Change in patient knowledge of his/her CHD (MyHeart score), comparing baseline to 1 month and 6 months follow-up. The MyHeart scale was developed for this study and has a grade 4.6 reading level. It consists of seven short answer or multiple-choice questions. Given the heterogeneity of prior medical and surgical interventions and need for medications in adolescents with heart disease, the denominator for some questions varied from one participant to the next. Accordingly, each participant was assigned a percentage correct score (numerator/denominator×100) at each time point. Higher percentage correct score reflects better patient knowledge of his/her CHD |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Clinic-based Educational Intervention Clinic-based Educational Intervention: This will involve a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport will be created covering the name of the teen's cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications and contact names and location of local adult CHD cardiologists will also be reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) will be presented to the teen who will be asked what advice he/she would offer to the teen in each of those scenarios. The teen will be given a study email address and encouraged to contact the APN by email or text messaging with follow-up questions. If no contact is initiated after 1 week, the APN will email or text (based on preference) the youth, to discuss additional questions. | 27 |
| Usual Care Youth seen in the Cardiology clinic see a nurse only to measure weight, height, and blood pressure. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies. Time-pressured clinic visits limit the opportunity to discuss many of the topics noted above. | 31 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 5 | 3 |
Baseline characteristics
| Characteristic | Clinic-based Educational Intervention | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 16.6 years STANDARD_DEVIATION 1 | 16.4 years STANDARD_DEVIATION 1 | 16.5 years STANDARD_DEVIATION 1 |
| Sex: Female, Male Female | 11 Participants | 17 Participants | 28 Participants |
| Sex: Female, Male Male | 16 Participants | 14 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 31 |
| serious Total, serious adverse events | 0 / 27 | 0 / 31 |
Outcome results
Primary
Transition Readiness Assessment Questionnaire (TRAQ) Score
The TRAQ is the most rigorously evaluated transition readiness questionnaire available and was developed in the USA. It has 29 items with two domains, self-management (16 items) and self-advocacy (13 ). The TRAQ is at a grade 5.7 reading level and uses a Likert scale. Each item is scored 1-5, with 1 being assigned for responses of No, I do not know how and a score of 5 assigned for responses of Yes, I always do this when I need to. The TRAQ scores produced include an overall score and a subscale score. The overall score and the subscale scores are calculated simply by taking the average score across the items in the questionnaire (or subscale). The higher the score, the greater the perceived self-management or self-advocacy skills of the participant. The lower scores indicate the participant has a lower perceived level of self-management or self-advocacy.
Time frame: Baseline, 1 month and 6 months
Population: The intervention involve a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. The youth in the usual care arm see a nurse for vitals. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Transition Readiness Assessment Questionnaire (TRAQ) Score | Baseline Self-management | 2.77 units on a scale | Standard Deviation 1.07 |
| Intervention | Transition Readiness Assessment Questionnaire (TRAQ) Score | 1 Month Self-management | 3.12 units on a scale | Standard Deviation 0.75 |
| Intervention | Transition Readiness Assessment Questionnaire (TRAQ) Score | 6 Month Self-advocacy | 4.38 units on a scale | Standard Deviation 0.56 |
| Intervention | Transition Readiness Assessment Questionnaire (TRAQ) Score | 1 Month Self-advocacy | 4.03 units on a scale | Standard Deviation 0.52 |
| Intervention | Transition Readiness Assessment Questionnaire (TRAQ) Score | Baseline Self-advocacy | 3.80 units on a scale | Standard Deviation 0.79 |
| Intervention | Transition Readiness Assessment Questionnaire (TRAQ) Score | 6 Month Self-management | 3.59 units on a scale | Standard Deviation 0.83 |
| Usual Care | Transition Readiness Assessment Questionnaire (TRAQ) Score | Baseline Self-advocacy | 3.92 units on a scale | Standard Deviation 0.67 |
| Usual Care | Transition Readiness Assessment Questionnaire (TRAQ) Score | 6 Month Self-advocacy | 4.01 units on a scale | Standard Deviation 0.95 |
| Usual Care | Transition Readiness Assessment Questionnaire (TRAQ) Score | Baseline Self-management | 2.95 units on a scale | Standard Deviation 0.98 |
| Usual Care | Transition Readiness Assessment Questionnaire (TRAQ) Score | 6 Month Self-management | 3.16 units on a scale | Standard Deviation 1.05 |
| Usual Care | Transition Readiness Assessment Questionnaire (TRAQ) Score | 1 Month Self-management | 3.08 units on a scale | Standard Deviation 0.93 |
| Usual Care | Transition Readiness Assessment Questionnaire (TRAQ) Score | 1 Month Self-advocacy | 3.88 units on a scale | Standard Deviation 0.75 |
Secondary
MyHeart Score
Change in patient knowledge of his/her CHD (MyHeart score), comparing baseline to 1 month and 6 months follow-up. The MyHeart scale was developed for this study and has a grade 4.6 reading level. It consists of seven short answer or multiple-choice questions. Given the heterogeneity of prior medical and surgical interventions and need for medications in adolescents with heart disease, the denominator for some questions varied from one participant to the next. Accordingly, each participant was assigned a percentage correct score (numerator/denominator×100) at each time point. Higher percentage correct score reflects better patient knowledge of his/her CHD
Time frame: Baseline, 1 month and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | MyHeart Score | Baseline MyHeart score (%) | 57 percentage of score | Standard Deviation 20 |
| Intervention | MyHeart Score | 1 Month MyHeart score (%) | 74 percentage of score | Standard Deviation 15 |
| Intervention | MyHeart Score | 6 Month MyHeart score (%) | 75 percentage of score | Standard Deviation 15 |
| Usual Care | MyHeart Score | Baseline MyHeart score (%) | 58 percentage of score | Standard Deviation 25 |
| Usual Care | MyHeart Score | 1 Month MyHeart score (%) | 61 percentage of score | Standard Deviation 25 |
| Usual Care | MyHeart Score | 6 Month MyHeart score (%) | 61 percentage of score | Standard Deviation 25 |