To investigate whether cardiac telerehabilitation using a personalized patient-centred ICT platform comprising remote monitoring and coaching of physical activity behaviour results in an improved long-term daily physical activity level as compared…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the change in physical activity level (physical
activity energy expenditure, PAEE) from baseline to 12 months.
Secondary outcome
PAEE at 3 months
maximal exercise capacity,
Body Mass Index
blood pressure
health related quality of life
anxiety/depression
health care costs
impact of telehealth care
patient empowerment
Background summary
Despite its proven effectiveness, cardiac rehabilitation (CR) is still vastly
underutilized due to transport difficulties, lack of time, scheduling care of
dependents, and reluctance to take part in group-based therapy. Also, physical
fitness and activity levels often decline and relapse into unhealthy behaviours
is common after completion of a typical 12-week centre-based CR program due to
a lack of development of self-management skills and a lack of communication
between caregivers. Therefore, there is an urgent need for innovative
rehabilitation methods aiming at an increase of CR uptake and more sustained
effects on cardiovascular risk behaviour.
Study objective
To investigate whether cardiac telerehabilitation using a personalized
patient-centred ICT platform comprising remote monitoring and coaching of
physical activity behaviour results in an improved long-term daily physical
activity level as compared to centre based CR in patients with coronary artery
disease (CAD).
Study design
Single-centre, randomized controlled trial among 300 patients with CAD entering
CR.
Intervention
Patients allocated to the intervention group receive access to a secured
personalized patient-centred web-based ICT platform which can be used to
register and adjust medication, rehabilitation goals, treatments, measurements
(e.g. physical activity, blood pressure, weight) and scheduled appointments
with caregivers. In addition, they are offered the possibility to perform
exercise training in their home environment with remote monitoring of training
and activity data using accelerometry and heart rate assessment. Coaching
consists of weekly video consulting by a physical therapist that has access to
the ICT platform containing the exercise data. After the initial CR period,
exercise data will be reviewed 4-weekly and patients are contacted if adherence
to the exercise goals decreases with 50% or more. Furthermore, patients are
encouraged to keep using the ICT platform and share information with relevant
caregivers.
Study burden and risks
The core component of the study intervention is a secured personalized
patient-centred web-based ICT platform. Patients assigned to the intervention
group will be offered the possibility to perform part of the training program
in their home environment with remote coaching using video consulting.
Furthermore, they are enabled to use the ICT platform to keep record of their
medication, rehabilitation goals, treatments, relevant measurements and
appointments. This information may also be shared with other caregivers.
Therefore, the intervention may be beneficial for participants. The risk of the
intervention is considered to be low, as exercise training is performed at home
only if the cardiologist approves and if no ischemia and ventricular
arrhythmias during low to moderate exercise intensity were observed during
symptom limiting exercise testing. Security of data transport is warranted by
encryption and signature layers.
Ds. Th. Fliednerstraat 1
Eindhoven 5631 BM
NL
Ds. Th. Fliednerstraat 1
Eindhoven 5631 BM
NL
Listed location countries
Age
Inclusion criteria
* Referral for cardiac rehabilitation due to coronary artery disease
* Indication for exercise training as a part of outpatient cardiac rehabilitation
* Personal computer with internet access
* Possession of a mobile phone with SMS-functionality
* Age * 18 years
* Able to speak, read and write Dutch
Exclusion criteria
* Ventricular arrhythmia or myocardial ischemia during low to moderate exercise intensity
* Heart failure NYHA class IV
* Severe comorbidity precluding exercise training
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL51367.015.14 |
OMON | NL-OMON23825 |