Skip to main content
. 2020 Oct 28;2020(10):CD013400. doi: 10.1002/14651858.CD013400.pub2

Klausen 2016.

Study characteristics
Methods Aim of study: to assess benefit and harms of adding an eHealth intervention to health education and individual counselling in adolescents with congenital heart disease
Study design: randomised clinical trial.
No. of centres: (nationwide?)
Country: Denmark
Participants N randomised total: 158; intervention: 81; comparator: 77
N lost to follow‐up total: 39; intervention: 23; comparator: 16
N analysed total: intervention: 81; comparator: 77
Severity of condition:
  • intervention: severe = 81;

  • comparator: severe = 77;


(Other reported – impossible to know so assumed severe; furthermore, included criteria state complex, albeit not referencing Hoffman 2002 criteria).
Inclusion criteria: age between 13 and 16 years, previous repair for a complex CHD, and assignment to lifelong medical follow‐up
Exclusion criteria: residual defects significant for physical activity restrictions, assessed by the participants' regular cardiologist
Interventions Description: 52‐week internet, mobile application, and SMS‐based programme delivering individually tailored text messages to encourage physical activity. Patients recorded exercise duration and type in a mobile application that translated intensity into virtual points, a system designed to provide motivation.
Setting:  home/internet delivery
Supervision: unsupervised but self‐reported adherence using an app.
Detail of exercise: activity encouragement.
Modalitytext/technology based PA encouragement
Intensity: text encouraged ‘high intensity’ but this it is probably more appropriate to state MVPA due to a loose definition of high intensity.
Resistance training included? NR
Impossible to assess dose
Outcomes
  • CRF

  • Physical activity (accelerometer)

Notes Adherence to the eHealth program was assessed by patient registration of physical activities via the eHealth application for at least two consecutive weeks during the trial.
Not statistically powered (needed 216 randomised)