Effects of eHealth physical activity encouragement in adolescents with complex congenital heart disease: The PReVaiL randomized clinical trial

Susanne Hwiid Klausen; Lars L Andersen; Lars Søndergaard; Janus Christian Jakobsen; Vibeke Zoffmann; Kasper Dideriksen; Anne Kruse; Ulla Ramer Mikkelsen; Jørn Wetterslev

doi:10.1016/j.ijcard.2016.07.092

Effects of eHealth physical activity encouragement in adolescents with complex congenital heart disease: The PReVaiL randomized clinical trial

Susanne Hwiid Klausen, Lars L Andersen, Lars Søndergaard, Janus Christian Jakobsen, Vibeke Zoffmann, Kasper Dideriksen, Anne Kruse, Ulla Ramer Mikkelsen, Jørn Wetterslev

Department of Clinical Medicine

11 Citations (Scopus)

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 years with 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 The primary outcome was maximal oxygen uptake (VO₂ peak) at 52 weeks after randomization. The secondary outcome was physical activity. Exploratory outcomes were generic and disease-specific questionnaires. Results In the intervention group, 58 patients (72%) completed the final test, but of those, only 46 (57%) fulfilled the compliance criteria of using the eHealth application for at least 2 consecutive weeks. 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). Between-group 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 adolescents with 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

Original language	English
Journal	International Journal of Cardiology
Volume	221
Pages (from-to)	1100-6
Number of pages	7
ISSN	0167-5273
DOIs	https://doi.org/10.1016/j.ijcard.2016.07.092
Publication status	Published - 15 Oct 2016

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10.1016/j.ijcard.2016.07.092

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Klausen, S. H., Andersen, L. L., Søndergaard, L., Jakobsen, J. C., Zoffmann, V., Dideriksen, K., Kruse, A., Mikkelsen, U. R., & Wetterslev, J. (2016). Effects of eHealth physical activity encouragement in adolescents with complex congenital heart disease: The PReVaiL randomized clinical trial. International Journal of Cardiology, 221, 1100-6. https://doi.org/10.1016/j.ijcard.2016.07.092

Effects of eHealth physical activity encouragement in adolescents with complex congenital heart disease : The PReVaiL randomized clinical trial. / Klausen, Susanne Hwiid; Andersen, Lars L; Søndergaard, Lars et al.

In: International Journal of Cardiology, Vol. 221, 15.10.2016, p. 1100-6.

Research output: Contribution to journal › Journal article › Research › peer-review

Klausen, SH, Andersen, LL, Søndergaard, L, Jakobsen, JC, Zoffmann, V, Dideriksen, K, Kruse, A, Mikkelsen, UR & Wetterslev, J 2016, 'Effects of eHealth physical activity encouragement in adolescents with complex congenital heart disease: The PReVaiL randomized clinical trial', International Journal of Cardiology, vol. 221, pp. 1100-6. https://doi.org/10.1016/j.ijcard.2016.07.092

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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 years with 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 The primary outcome was maximal oxygen uptake (VO2 peak) at 52 weeks after randomization. The secondary outcome was physical activity. Exploratory outcomes were generic and disease-specific questionnaires. Results In the intervention group, 58 patients (72%) completed the final test, but of those, only 46 (57%) fulfilled the compliance criteria of using the eHealth application for at least 2 consecutive weeks. 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). Between-group 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 adolescents with 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",

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AU - Jakobsen, Janus Christian

AU - Zoffmann, Vibeke

AU - Dideriksen, Kasper

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AU - Mikkelsen, Ulla Ramer

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N2 - 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 years with 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 The primary outcome was maximal oxygen uptake (VO2 peak) at 52 weeks after randomization. The secondary outcome was physical activity. Exploratory outcomes were generic and disease-specific questionnaires. Results In the intervention group, 58 patients (72%) completed the final test, but of those, only 46 (57%) fulfilled the compliance criteria of using the eHealth application for at least 2 consecutive weeks. 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). Between-group 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 adolescents with 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

AB - 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 years with 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 The primary outcome was maximal oxygen uptake (VO2 peak) at 52 weeks after randomization. The secondary outcome was physical activity. Exploratory outcomes were generic and disease-specific questionnaires. Results In the intervention group, 58 patients (72%) completed the final test, but of those, only 46 (57%) fulfilled the compliance criteria of using the eHealth application for at least 2 consecutive weeks. 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). Between-group 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 adolescents with 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

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JO - International Journal of Cardiology

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ER -

Effects of eHealth physical activity encouragement in adolescents with complex congenital heart disease: The PReVaiL randomized clinical trial

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