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

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

    Publikation: Bidrag til tidsskriftTidsskriftsartikelForskningpeer review

    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
    OriginalsprogEngelsk
    TidsskriftInternational Journal of Cardiology
    Vol/bind221
    Sider (fra-til)1100-1106
    Antal sider7
    ISSN0167-5273
    DOI
    StatusUdgivet - 15 okt. 2016

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