CHAPTER: Congenital Heart Adolescents: Program of Transition Evaluation Research

• Sponsor: University of Alberta (Other)
• Overall Status: Completed
• CT.gov ID: NCT01286480
• Collaborator: Women and Children's Health Research Institute, Canada (Other), Stollery Children's Hospital Foundation (Other)
• Enrollment: 66
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Defects	Behavioral: Clinic-based Educational Intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Evaluation of Novel Transition Interventions for Youth With Congenital Heart Disease
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stollery Children's Hospital	Edmonton	Alberta	Canada	T6G 2B7

Sponsors and Collaborators

• University of Alberta
• Women and Children's Health Research Institute, Canada
• Stollery Children's Hospital Foundation

Investigators

• Principal Investigator: Andrew S Mackie, MD, SM, University of Alberta

Study Documents (Full-Text)

None provided.

More Information

Publications

• Sawicki GS, Lukens-Bull K, Yin X, Demars N, Huang IC, Livingood W, Reiss J, Wood D. Measuring the transition readiness of youth with special healthcare needs: validation of the TRAQ--Transition Readiness Assessment Questionnaire. J Pediatr Psychol. 2011 Mar;36(2):160-71. doi: 10.1093/jpepsy/jsp128. Epub 2009 Dec 29.
• Warnes CA, Liberthson R, Danielson GK, Dore A, Harris L, Hoffman JI, Somerville J, Williams RG, Webb GD. Task force 1: the changing profile of congenital heart disease in adult life. J Am Coll Cardiol. 2001 Apr;37(5):1170-5.

• Responsible Party: Andrew Mackie, Principal Investigator, University of Alberta
• ClinicalTrials.gov Identifier: NCT01286480
• Other Study ID Numbers: AM-Chapter-01
• First Posted: Jan 31, 2011
• Last Update Posted: Jun 26, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Andrew Mackie, Principal Investigator, University of Alberta: Health Care Transition; Adolescent
• Additional relevant MeSH terms: Heart Defects, Congenital

Study Results

Participant Flow

Arm/Group Title	Intervention Arm	Usual Care
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	32	34
COMPLETED	27	31
NOT COMPLETED	5	3

Baseline Characteristics

Arm/Group Title	Clinic-based Educational Intervention	Usual Care	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	27	31	58
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	16.6 (1.0)	16.4 (1.0)	16.5 (1.0)
Sex: Female, Male (Count of Participants)
Female	11 40.7%	17 54.8%	28 48.3%
Male	16 59.3%	14 45.2%	30 51.7%

Outcome Measures

1. Primary Outcome

Title	Transition Readiness Assessment Questionnaire (TRAQ) Score
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Intervention	Usual Care
Arm/Group Description	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.	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.
Measure Participants	27	31
Baseline Self-management	2.77 (1.07)	2.95 (0.98)
Baseline Self-advocacy	3.80 (0.79)	3.92 (0.67)
1 Month Self-management	3.12 (0.75)	3.08 (0.93)
1 Month Self-advocacy	4.03 (0.52)	3.88 (0.75)
6 Month Self-management	3.59 (0.83)	3.16 (1.05)
6 Month Self-advocacy	4.38 (0.56)	4.01 (0.95)

2. Secondary Outcome

Title	MyHeart Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Usual Care
Arm/Group Description	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.	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.
Measure Participants	27	31
Baseline MyHeart score (%)	57 (20)	58 (25)
1 Month MyHeart score (%)	74 (15)	61 (25)
6 Month MyHeart score (%)	75 (15)	61 (25)

Adverse Events

Arm/Group Title	Intervention		Usual Care
Arm/Group Description	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.		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.
All Cause Mortality
	Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/31 (0%)

Limitations/Caveats

single centre trial most interventions were conducted by a single nurse assessed self-management behaviours based on self-report long-term follow-up and attendance in an adult cardiac clinic were not assessed

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.