Congenital Heart Adolescents: Program of Transition Evaluation Research

NCT01286480 | Completed Results

• 1 other identifier: AM-Chapter-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Defects

Keywords

Health Care Transition; Adolescent

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 1 month and 6 months

Secondary Outcomes (1)

• MyHeart Score

  Baseline, 1 month and 6 months

Study Arms (2)

Clinic-based Educational Intervention

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Clinic-based Educational Intervention BEHAVIORAL

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.

Clinic-based Educational Intervention

Eligibility Criteria

• Age: 15 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Developmental Delay, reading level below grade 6 based on patient or parent report

Sponsors & Collaborators

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

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (3)

• 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.

  PMID: 20040605 BACKGROUND

• 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. doi: 10.1016/s0735-1097(01)01272-4. No abstract available.

  PMID: 11300418 BACKGROUND

• Mackie AS, Islam S, Magill-Evans J, Rankin KN, Robert C, Schuh M, Nicholas D, Vonder Muhll I, McCrindle BW, Yasui Y, Rempel GR. Healthcare transition for youth with heart disease: a clinical trial. Heart. 2014 Jul;100(14):1113-8. doi: 10.1136/heartjnl-2014-305748. Epub 2014 May 19.

  PMID: 24842870 RESULT

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

1. single centre trial 2. most interventions were conducted by a single nurse 3. assessed self-management behaviours based on self-report 4. long-term follow-up and attendance in an adult cardiac clinic were not assessed

Results Point of Contact

• Title: Dr. Andrew Mackie
• Organization: University of Alberta

andrew.mackie@ualberta.ca

780-407-8361

Study Officials

• Andrew S Mackie, MD, SM

  University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: January 31, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 26, 2017
• Results First Posted: June 26, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)