Abstract
Objective: To assess benefit and harms of adding an eHealth intervention to health education and individual
counseling in adolescents with congenital heart disease.
Design: Randomized clinical trial.
Setting: Denmark.
Patients: A total of 158 adolescents aged 13–16 yearswith no physical activity restrictions after repaired complex
congenital heart disease.
Interventions: PReVaiL consisted of individually tailored eHealth encouragement physical activity for 52 weeks.
All patients received 45 min of group-based health education and 15 min of individual counseling involving patients'
parents.
Outcomes: Theprimaryoutcomewasmaximal oxygenuptake (VO2 peak) at 52weeks after randomization. The secondary
outcome was physical activity. Exploratory outcomes were generic and disease-specific questionnaires.
Results: In the intervention group, 58 patients (72%) completedthe final test, but of those, only 46 (57%) fulfilled the
compliance criteria of using the eHealth application for at least 2 consecutiveweeks. In the control group, 61 patients
(79%) completed both exercise tests. Adjusted for baseline values, the difference between the intervention group
and the control group in mean VO2 peak at 1 year was −0.65 ml·kg−1·min−1 (95% CI −2.66 to 1.36). Betweengroup
differences at 1 year in physical activity, generic health-related quality of life, and disease-specific quality of
life were not statistically significant.
Conclusions: Adding a tailored eHealth intervention to health education and individual counseling did not affect outcomes
among adolescentswith congenital heart disease. Our results do not support the use of this eHealth intervention
in adolescents with complex congenital heart disease.
Trial registration: Clinical trials.gov identifier: NCT01189981
counseling in adolescents with congenital heart disease.
Design: Randomized clinical trial.
Setting: Denmark.
Patients: A total of 158 adolescents aged 13–16 yearswith no physical activity restrictions after repaired complex
congenital heart disease.
Interventions: PReVaiL consisted of individually tailored eHealth encouragement physical activity for 52 weeks.
All patients received 45 min of group-based health education and 15 min of individual counseling involving patients'
parents.
Outcomes: Theprimaryoutcomewasmaximal oxygenuptake (VO2 peak) at 52weeks after randomization. The secondary
outcome was physical activity. Exploratory outcomes were generic and disease-specific questionnaires.
Results: In the intervention group, 58 patients (72%) completedthe final test, but of those, only 46 (57%) fulfilled the
compliance criteria of using the eHealth application for at least 2 consecutiveweeks. In the control group, 61 patients
(79%) completed both exercise tests. Adjusted for baseline values, the difference between the intervention group
and the control group in mean VO2 peak at 1 year was −0.65 ml·kg−1·min−1 (95% CI −2.66 to 1.36). Betweengroup
differences at 1 year in physical activity, generic health-related quality of life, and disease-specific quality of
life were not statistically significant.
Conclusions: Adding a tailored eHealth intervention to health education and individual counseling did not affect outcomes
among adolescentswith congenital heart disease. Our results do not support the use of this eHealth intervention
in adolescents with complex congenital heart disease.
Trial registration: Clinical trials.gov identifier: NCT01189981
Originalsprog | Engelsk |
---|---|
Tidsskrift | International Journal of Cardiology |
Vol/bind | 221 |
Sider (fra-til) | 1100-1106 |
Antal sider | 7 |
ISSN | 0167-5273 |
DOI | |
Status | Udgivet - 15 okt. 2016 |
Emneord
- Børn og unge
- Undersøgelsesdesign, teori og metode