The objective of this study is to measure the effect of a smart technology intervention on patients after AMI.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study will be the percentage of patients with
controlled blood pressure in both groups.
Secondary outcome
• Scores of SFQ-questionnaires
• Hospital-patient contact
• Amount of hospital visits
• Scores of Rand-36 questionnaires
• Major Adverse Cardiac Events
• Time between discharge from hospital and completion of device installation
• Cost-effectiveness of interventions in both groups
• Scores of medication-adherence questionnaires
Background summary
Smart technology could improve quality of care in patients after acute
myocardial infarction (AMI) with either ST or non-ST elevation.
Study objective
The objective of this study is to measure the effect of a smart technology
intervention on patients after AMI.
Study design
The design of the study is a single-center, open randomized-controlled trial.
Intervention
Patients will be randomized to either *The Box* or regular follow-up. Patients
who have been randomized to The Box will receive a box containing a smartphone
compatible ECG monitor, a weight scale, an activity tracker and a blood
pressure monitor. If patients are randomized to The Box, two of the four
outpatient clinic visits will be replaced by an e-consult, in which a patient
does not have to go to the hospital, but talks with his or her doctor or nurse
practitioner via a secured video connection.
Study burden and risks
All devices used in this study are non-invasive, easy-to-use and electrically
safe within its intended use. Using the devices is with very limited risks.
This study has some potential benefits for patients: first, patients can
measure their own blood pressure, weight and activity, as well as record their
own ECG. This can reassure patients and give them more insight in their own
health (the so-called *patient empowerment*). Furthermore, more data gives the
doctor more insight in the health of patients. This might lead to early
detection of hypertension or arrhythmias such as atrial fibrillation. Lastly,
due to the video connection system, patients do not have to come to the
hospital, while receiving the same quality of care. A drawback is that patients
have to measure their blood pressure, weight and ECG every day. Furthermore,
patients have to fill in a couple of questionnaires, which will take some of
their time.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
1. Myocardial infarction (either ST or NST elevation)
2. Patient is able to communicate in English or Dutch language
3. Patient is familiar with smartphone technology
Exclusion criteria
1. Body Mass Index > 35 kg•m-2
2. Patient is included in another randomized controlled trial
3. Patient is <18 years old
4. Patient is considered an incapacitated adult
5. Patient is pregnant
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL56453.058.16 |