The proposed study aims to assess the technical reliability and user friendliness of the Intel platform in 25 patients who are in stable heart failure. Subsequently, the cost-efficacy of the technology will be assessed in 100 patients with a focus…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. What was the patient*s satisfaction rating ( incl. confidence in PHS ) of
their PHS experience ?
2. What was the nurse*s satisfaction rating of their PHS experience ?
3. What was the GP/Specialist*s satisfaction rating of their PHS experience ?
4. What was the average time spent per service center nurse per month ?
5. What percentage of the equipment malfunctioned ?
6. What was the patient*s adherence rate to the PHS ( incl number of patients
refusing to participate ) ?
7. What was the average length of time from monitoring to nurse call-back ?
Secondary outcome
1 Blood Pressure Control. Evaluation of the change and variation of daily BP
measurements taken over a 3/6 month period of time.
2. Weight Control. Evaluation of the change and variation of daily weight
measurements taken over a 3 month period of time.
3. Blood Oxygen Saturation Control. Evaluation of the change and variation of
daily blood oxygen saturation measurements taken over a 3 month period of time.
4. Qualitative data (observations, anecdotes, patient comments, etc.) on the
installation, training, patient/caregiver/clinician/technician experience, etc.
Background summary
Telemonitoring for patients with stable Congestive Heart Failure my improve the
patient's span of control and patient compliance to monitoring. It also
improves cost-efficacy of the application of medical and nursing care.
Study objective
The proposed study aims to assess the technical reliability and user
friendliness of the Intel platform in 25 patients who are in stable heart
failure. Subsequently, the cost-efficacy of the technology will be assessed in
100 patients with a focus on process and system analysis. In this phase also
the effect of teleconsulting will be subject of study.
Study design
The subject of the study is the use of the Intel Personal Health System. The
system consist of a reinforced laptop connected to ADSL. Via the Laptop blood
pressure, weight, and oxygen saturation are measured according to a preset data
acquisition protocol. The study is an observational prospective study with
assess the measurements. The measurement tools for bloodpressure, weight and
oxygen saturation are already in use on a large scale and appeared reliable. In
both fases of the study data are registered and stored in a personal patient
dossier within a specially operated study database. The data collection period
for the first phase is 3 months. In the second part of the study
video-conferencing and teleconsulting will be available. Another 100 patients
enrolled in three non-university hospital heart failure clinics will be invited
to participate.
Study burden and risks
Participant*s identity shall be known only to the researchers / technicians who
visit the participant*s home to install equipment or perform testing. All
participant coded data shall be kept in password protected computers or locked
file drawers. Personal health information shall not be allowed to be a part of
any data leaving AMC and/or Intel/IPT. Privacy and security risks will also be
outlined in the patient informed consent document.
The overall risk of this observational and subjective study is considered very
low (Minimal risk category). Participation in the study doesn*t interfere with
the regular controls by the nursing or medical staff. In this study, patients
suffer from congestive heart failure but are in a steady control state that
doesn*t require intensive monitoring.
The Intel® Personal Health System is CE marked for this study in the
Netherlands. Therefore, safety and applicable regulatory compliance shall be
met prior to the medical device being deployed in hospitals and homes.
2200 Mission College Boulevard
CA 95052
USA
2200 Mission College Boulevard
CA 95052
USA
Listed location countries
Age
Inclusion criteria
Patients with congestive heart failure in a stable condition wether or not post-surgery, treated by a cardiologist.
Patients must be capable of handling the computer and the monitoring equipment
Patients must understand the instructions by nurse and doctor
Exclusion criteria
Progressive heart failure.
No ADSL or insufficient knowledge of English ( according to a simple language test)
Serious co-morbidity and end-stage disease of any kind
Mental shortcomings
Design
Recruitment
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 | NL23264.018.08 |