Klausen Susanne Hwiid, Andersen Lars L, Søndergaard Lars, Jakobsen Janus Christian, Zoffmann Vibeke, Dideriksen Kasper, Kruse Anne, Mikkelsen Ulla Ramer, Wetterslev Jørn
Research Unit for Women's and Children's Health, The Juliane Marie Centre, University Hospital Rigshospitalet, Copenhagen, Denmark.
National Research Centre for the Working Environment, Copenhagen, Denmark.
Int J Cardiol. 2016 Oct 15;221:1100-6. doi: 10.1016/j.ijcard.2016.07.092. Epub 2016 Jul 16.
To assess benefit and harms of adding an eHealth intervention to health education and individual counseling in adolescents with congenital heart disease.
Randomized clinical trial.
Denmark.
A total of 158 adolescents aged 13-16years with no physical activity restrictions after repaired complex congenital heart disease.
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.
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.
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.
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.
Clinical trials.gov identifier: NCT01189981.
评估在先天性心脏病青少年的健康教育和个体咨询中增加电子健康干预措施的益处和危害。
随机临床试验。
丹麦。
共有158名年龄在13 - 16岁的青少年，其复杂先天性心脏病修复后无身体活动限制。
PReVaiL包括为个体量身定制的电子健康促进身体活动方案，为期52周。所有患者均接受45分钟的小组健康教育以及15分钟涉及患者父母的个体咨询。
主要结局是随机分组后52周时的最大摄氧量（VO2峰值）。次要结局是身体活动。探索性结局是通用和疾病特异性问卷。
在干预组中，58名患者（72%）完成了最终测试，但其中只有46名（57%）符合连续至少使用电子健康应用程序2周的依从性标准。在对照组中，61名患者（79%）完成了两项运动测试。校正基线值后，干预组与对照组在1年时平均VO2峰值的差异为-0.65ml·kg⁻¹·min⁻¹（95%CI -2.66至1.36）。1年时两组在身体活动、通用健康相关生活质量和疾病特异性生活质量方面的组间差异无统计学意义。
在健康教育和个体咨询中增加量身定制的电子健康干预措施对先天性心脏病青少年的结局没有影响。我们的结果不支持在患有复杂先天性心脏病的青少年中使用这种电子健康干预措施。
ClinicalTrials.gov标识符：NCT01189981。
