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

Institut for Klinisk Medicin

11 Citationer (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

Originalsprog	Engelsk
Tidsskrift	International Journal of Cardiology
Vol/bind	221
Sider (fra-til)	1100-6
Antal sider	7
ISSN	0167-5273
DOI	https://doi.org/10.1016/j.ijcard.2016.07.092
Status	Udgivet - 15 okt. 2016

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10.1016/j.ijcard.2016.07.092

Citationsformater

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.

I: International Journal of Cardiology, Bind 221, 15.10.2016, s. 1100-6.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › 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, bind 221, s. 1100-6. https://doi.org/10.1016/j.ijcard.2016.07.092

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

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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author = "Klausen, {Susanne Hwiid} and Andersen, {Lars L} and Lars S{\o}ndergaard and Jakobsen, {Janus Christian} and Vibeke Zoffmann and Kasper Dideriksen and Anne Kruse and Mikkelsen, {Ulla Ramer} and J{\o}rn Wetterslev",

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AU - Klausen, Susanne Hwiid

AU - Andersen, Lars L

AU - Søndergaard, Lars

AU - Jakobsen, Janus Christian

AU - Zoffmann, Vibeke

AU - Dideriksen, Kasper

AU - Kruse, Anne

AU - Mikkelsen, Ulla Ramer

AU - Wetterslev, Jørn

PY - 2016/10/15

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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

Abstract

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