Trial Outcomes & Findings for Congenital Heart Adolescents: Program of Transition Evaluation Research (NCT NCT01286480)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

66 participants

Primary outcome timeframe

Baseline, 1 month and 6 months

Results posted on

2017-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Arm The intervention was conducted by one of three experienced cardiology nurses following intervention-facilitation training and fidelity assurance. The intervention involved a meeting with the nurse and the participant, with the exception of three interventions also attended by a father (n=1), an uncle (n=1) and a participant's friend (n=1). Interventions were held in a quiet room without other distractions, a short walk from the cardiology clinic. The order of the intervention was consistently followed, and the study nurse completed a log and field notes to document any difficulties that were encountered during the intervention and the participant's reaction, level of engagement, questions and body language. Interventions were offered on the same day as a routine clinic visit, or at a later date, depending on the participant's preference.	Usual Care Participants allocated to the usual care group were unaware of the intervention being offered to the treatment group. This was intended to prevent contamination by self-education or other means.
Overall Study STARTED	32	34
Overall Study COMPLETED	27	31
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Arm The intervention was conducted by one of three experienced cardiology nurses following intervention-facilitation training and fidelity assurance. The intervention involved a meeting with the nurse and the participant, with the exception of three interventions also attended by a father (n=1), an uncle (n=1) and a participant's friend (n=1). Interventions were held in a quiet room without other distractions, a short walk from the cardiology clinic. The order of the intervention was consistently followed, and the study nurse completed a log and field notes to document any difficulties that were encountered during the intervention and the participant's reaction, level of engagement, questions and body language. Interventions were offered on the same day as a routine clinic visit, or at a later date, depending on the participant's preference.	Usual Care Participants allocated to the usual care group were unaware of the intervention being offered to the treatment group. This was intended to prevent contamination by self-education or other means.
Overall Study Withdrawal by Subject	5	3

Baseline Characteristics

Congenital Heart Adolescents: Program of Transition Evaluation Research

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clinic-based Educational Intervention n=27 Participants 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.	Usual Care n=31 Participants 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.	Total n=58 Participants Total of all reporting groups
Age, Continuous	16.6 years STANDARD_DEVIATION 1.0 • n=5 Participants	16.4 years STANDARD_DEVIATION 1.0 • n=7 Participants	16.5 years STANDARD_DEVIATION 1.0 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	17 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention n=27 Participants This involves a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport is 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 are also reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) are 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.	Usual Care n=31 Participants 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.
Transition Readiness Assessment Questionnaire (TRAQ) Score Baseline Self-management	2.77 units on a scale Standard Deviation 1.07	2.95 units on a scale Standard Deviation 0.98
Transition Readiness Assessment Questionnaire (TRAQ) Score Baseline Self-advocacy	3.80 units on a scale Standard Deviation 0.79	3.92 units on a scale Standard Deviation 0.67
Transition Readiness Assessment Questionnaire (TRAQ) Score 1 Month Self-management	3.12 units on a scale Standard Deviation 0.75	3.08 units on a scale Standard Deviation 0.93
Transition Readiness Assessment Questionnaire (TRAQ) Score 1 Month Self-advocacy	4.03 units on a scale Standard Deviation 0.52	3.88 units on a scale Standard Deviation 0.75
Transition Readiness Assessment Questionnaire (TRAQ) Score 6 Month Self-management	3.59 units on a scale Standard Deviation 0.83	3.16 units on a scale Standard Deviation 1.05
Transition Readiness Assessment Questionnaire (TRAQ) Score 6 Month Self-advocacy	4.38 units on a scale Standard Deviation 0.56	4.01 units on a scale Standard Deviation 0.95

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Intervention n=27 Participants This involves a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport is 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 are also reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) are 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.	Usual Care n=31 Participants 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.
MyHeart Score Baseline MyHeart score (%)	57 percentage of score Standard Deviation 20	58 percentage of score Standard Deviation 25
MyHeart Score 1 Month MyHeart score (%)	74 percentage of score Standard Deviation 15	61 percentage of score Standard Deviation 25
MyHeart Score 6 Month MyHeart score (%)	75 percentage of score Standard Deviation 15	61 percentage of score Standard Deviation 25

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andrew Mackie

University of Alberta

Phone: 780-407-8361

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place