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.
  
  
  METHODS
  Randomized clinical trial.
  
  
  METHODS
  Denmark.
  
  
  METHODS
  A total of 158 adolescents aged 13-16years with no physical activity restrictions after repaired complex congenital heart disease.
  
  
  METHODS
  PReVaiL consisted of individually tailored eHealth encouragement physical activity for 52weeks. All patients received 45min of group-based health education and 15min of individual counseling involving patients' parents.
  
  
  RESULTS
  The primary outcome was maximal oxygen uptake (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%) 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 1year was -0.65ml·kg(-1)·min(-1) (95% CI -2.66 to 1.36). Between-group differences at 1year 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.
  
  
  BACKGROUND
  Clinical trials.gov identifier: NCT01189981.
authors.affiliation: Research Unit for Women's and Children's Health, The Juliane Marie Centre, University Hospital Rigshospitalet, Copenhagen, Denmark. Electronic address: susanne.hwiid.klausen@regionh.dk.
authors.forename: Susanne Hwiid
authors.initials: SH
authors.lastname: Klausen
authors.affiliation: National Research Centre for the Working Environment, Copenhagen, Denmark.
authors.forename: Lars L
authors.initials: LL
authors.lastname: Andersen
authors.affiliation: The Heart Centre, Copenhagen University Hospital Rigshospitalet, Denmark.
authors.forename: Lars
authors.initials: L
authors.lastname: Søndergaard
authors.affiliation: Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital Rigshospitalet, Denmark; Department of Cardiology, Holbæk Hospital, Denmark.
authors.forename: Janus Christian
authors.initials: JC
authors.lastname: Jakobsen
authors.affiliation: Research Unit for Women's and Children's Health, The Juliane Marie Centre, University Hospital Rigshospitalet, Copenhagen, Denmark; Institute of Clinical Medicine, Copenhagen University, Copenhagen, Denmark.
authors.forename: Vibeke
authors.initials: V
authors.lastname: Zoffmann
authors.affiliation: Institute of Sports Medicine, Department of Orthopaedic Surgery M, Bispebjerg Hospital and Centre for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.
authors.forename: Kasper
authors.initials: K
authors.lastname: Dideriksen
authors.affiliation: Department of Nursing, Faculty of Health and Technology, Metropolitan University College, Copenhagen, Denmark.
authors.forename: Anne
authors.initials: A
authors.lastname: Kruse
authors.affiliation: Institute of Sports Medicine, Department of Orthopaedic Surgery M, Bispebjerg Hospital and Centre for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.
authors.forename: Ulla Ramer
authors.initials: UR
authors.lastname: Mikkelsen
authors.affiliation: Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital Rigshospitalet, Denmark.
authors.forename: Jørn
authors.initials: J
authors.lastname: Wetterslev
mesh_terms: D000293:Adolescent; D013504:Cardiovascular Surgical Procedures / Q000534:rehabilitation*; D003718:Denmark; D015444:Exercise / Q000502:physiology / Q000523:psychology; D005260:Female; D006266:Health Education / Q000379:methods*; D006330:Heart Defects, Congenital / Q000175:diagnosis / Q000523:psychology / Q000534:rehabilitation / Q000601:surgery; D006801:Humans; D008297:Male; D010101:Oxygen Consumption / Q000502:physiology; D010349:Patient Compliance; D063868:Patient Outcome Assessment; D010809:Physical Fitness; D011788:Quality of Life; D011795:Surveys and Questionnaires; D017216:Telemedicine / Q000379:methods*
keywords: Adolescent; Congenital; Exercise; Heart defects; eHealth