CHF Home Telemonitoring: A Home Telemonitoring Service for Chronic Heart Failure Patients on Trial
CHF Home Telemonitoring: A Home Telemonitoring Service for Chronic Heart Failure Patients on Trial
Providing patients with chronic heart failure (CHF) access to remote monitoring, for example
 by telephone or telemonitoring using wireless technology, reduces deaths and hospitalisations
 and may provide benefits on health care costs and quality of life. Remote monitoring of
 patients with chronic heart failure can reduce pressure on resources, particularly for
 conditions like chronic heart failure, which exert a large burden on health services. These
 are conclusions of the Cochrane Systematic Review from 2010.

 In Norway the costs for treatment of chronic heart failure are vast, both concerning hospital
 treatment, daily use of medication over years, and loss of quality of life for patients and
 their family caregivers. Generally there is little knowledge about what is gained for the
 billions used. In Norway no telemonitoring services are established and hence no
 investigations have yet been published. Thus it seems that current evidence of effectiveness
 and quality is insufficient to recommend usage. The structure and funding streams in
 Norwegian health services are different from other countries and the conventional services
 that the intervention has been compared to in previous studies, are most likely
 heterogeneous. It is thus important to investigate Norwegian conditions.

 Advanced telemonitoring technology with electronic transfer of physiological data such as
 blood pressure and weight is currently being used in research and established routine
 services in several countries in Europe, amongst them the Netherlands, Germany and the United
 Kingdom.

 The proposed project intends to introduce such a strategy as an avenue for exploring
 promising new services that would not otherwise be available in Norway. The service consists
 of daily monitoring the patients' weight and blood pressure directly from their home;
 automatically and securely transmit the values to a server at the University Hospital of
 North Norway (UNN); and monitor the values by a trained nurse at the Heart polyclinic.

 The primary objective of this study is thus to explore whether, as compared to current care
 from the Heart Polyclinic, the introduction of home telemonitoring will reduce hospital
 readmissions and will, in addition, be cost-effective. This is in line with current
 directions of European telemonitoring programmes for patients with chronic heart failure.
 This result may define if the telemonitoring of heart failure patients is feasible for Norway
 or not at all.
All data collected by the equipment placed at the patient's home will be directly and
 securely transferred to the Heart polyclinic of the University Hospital of North Norway
 (UNN). All data is anonymous as explained below, only the weight and the codes with the
 answers to the questionnaire are send.

 Each day a nurse is assigned as responsible for the heart remote monitoring system. The nurse
 in charge must read the heart remote monitoring email in the morning every day, seven days a
 week. If an alert email has been received, then the nurse logs into the system's dashboard
 and reads the data displayed there for that patient. Then the nurse will try to phone the
 patient to clarify the situation. Until this moment the procedure protocol differs from the
 ordinary routines as the notification of a case is usually raised by a phone call from the
 patient or a hospitalisation. But from this moment on, the procedure protocol is the same as
 for all patients treated by the Heart polyclinic, i.e. if the nurse evaluates the situation
 to need a further follow-up, then the nurse contacts the patient's general practitioner (GP)
 by phone (as said this is procedure as usual). The hospital's Heart polyclinic has the same
 responsibility for the treatment of the patients, both in the intervention arm and the
 control arm.

 Each one of the patients assigned to the intervention arm will be following this procedure
 during 6 months. For the patients assigned to the control arm they will receive treatment as
 usual also during a period of 6 months. Data stored in the system is anonymised. All patients
 are uniquely identified by a number, the Unique Identifier (UID), in the system, the
 connection between the UID and the real identity being only stored in a file in a secured
 personal computer unconnected from any network, staying in an office at the heart polyclinic.
 Once a week, the UIDs' file stored in the study personal computer at the Heart polyclinic is
 transferred to a hardware protected pen drive. The pen drive in then placed in another
 building at the UNN. This procedure is of the responsibility of the UNN's department for
 "E-health and information and communications technology (ICT)". In this way only two copies
 of the file are stored in separate buildings. No reference to the study name is mentioned in
 this file.

 As a pilot study, a prototype of the platform was built. It consisted of a wireless weight
 scale and also a blood pressure meter prepared to send the values through the home Wi-Fi
 network to a connected portable computer. The portable computer could then send the encrypted
 measurements to a server at UNN.

 After the first two months of pilot testing, the patient was satisfied with the usability of
 the solution and the reliability of the service was proven.

 The platform deployed and tested in the pilot study has been extended to include
 functionalities for multiple patients. A dashboard showing all the measurements received
 (unidentified) has been developed for the polyclinic and used by the responsible clinician
 (the nurse on daily duty). This data is unidentified and consists of a registration of blood
 pressure and weight, the encoded answers to the questionnaire attached (example: Q3A2 means
 that question 3 got the answer 2 in the questionnaire). The responsible nurse at the Heart
 Polyclinic has access to the dashboard. When a situation requiring the nurse intervention
 arises, the system sends an alerting email to a pre-defined address (usually the nurse's
 email account as it will be done in this study).

 The design of the randomized controlled trial (RCT) Power analysis The inclusion of 40
 patients is based upon the total number of new patients served by the polyclinic per year
 during the 2 last years. For this study a sample size was calculated based on a readmission
 rate of 70% of the patients per year on average with a standard deviation of 20pp (percentage
 points). The values are adequate, based on patients who have received treatment within the
 Heart Polyclinic and also replicating the study by Antonicelli, published in the Journal of
 telemedicine and Telecare "Impact of telemonitoring at home on the management of elderly
 patients with congestive heart failure" in 2008.

 It was assumed by the clinical team that a 1/3 reduction on the rate of readmissions (down to
 47%) would be clinically relevant as the margin of superiority for the intervention. To have
 95% certainty (power) that a test at 0.05 level of significance would find a statistically
 significant difference between the means, the study would include a minimum of 20 patients in
 each group.

 The planned RCT The telemonitoring service will be offered to all patients admitted at UNN's
 Heart Polyclinic, satisfying the inclusion criteria. The study comprises an intervention arm
 testing the proposed telemonitoring service and a control arm with the current treatment.

 Patients assigned to the intervention arm receive a home telemonitoring kit consisting of a
 tablet, a wireless weight scale and a portable blood pressure meter. The patient is asked to
 weigh him- or herself every day and the monitoring procedure happens as previously described.
 In addition a measurement of the blood pressure is also made.

 Patients assigned to the control arm receive treatment as usual, consisting of a
 recommendation to weigh themselves at home, using their own weight scale, and to report by
 phone to the polyclinic if there is a significant change in weight.

 The study calendar is shown below. Recruiting period: 14 months Follow-up period: 6 months
 Number of patients: 40

 Randomization: will be performed using sequentially numbered sealed opaque envelopes

 Blinding: independent outcome assessors and data analysts are blinded to which group the
 patient has been assigned to (patients are not blinded due to the nature of the
 intervention).

 Challenges and opportunities Qualitative research with semi structured interviews. Patients
 in the intervention group and health care professionals will be asked to state their opinion
 of the service. The research team will also observe patients' interactions with the system
 after the 6 months of the study. A qualitative summary and thematic analysis of significant
 features of opinions and actions will be connected to best practices. The purpose is to be
 able to understand how best practices can be developed in the Northern Norwegian context, and
 describe their mechanisms. The innovation intention is to adjust the services as they
 develop, by considering the identified additional conditions for future development.

 Ethics and privacy With recent events and advances in information technology and the
 Internet, confidentiality regarding handling of patient private data has become a critical
 aspect of a study design as privacy is a fundamental right in the public healthcare domain.
 In this project confidentiality of private health information will be ensured according to
 the Health Personnel Act § 21, helsepersonelloven § 21, and described in LOV2001-05-18 nr.24
 (Helse- og omsorgsdepartementet, 2001). All private personal data will be de-identified:
 every unique identifying number, characteristic, or code identifiers of the individual or of
 relatives, employers, or household members of the individual will be removed so that the
 information can be used alone or in combination with other information. The resulting data
 will be analysed by a statistician to ensure that no individually identifiable health
 information remains. The consent of participants will be required by means of providing a
 letter of informed consent to be signed.
Inclusion Criteria:

 Presence of CHF signs and symptoms such as dyspnoea and peripheral or pulmonary oedema
 requiring diuretic administration (New York Heart Association [NYHA] functional class
 II-IV); and ejection fraction (EF) under 40% combined or not with a left ventricular
 filling pattern supporting the presence of diastolic dysfunction, according to the American
 College of Cardiology/American Heart Association Guidelines for chronic heart failure.

 Exclusion Criteria:

 Severe psychiatric disturbance diagnosed by DSM-IV-TR criteria. Any disability that may
 prevent the subject from completing the informed consent form or other study requirements.

 Medication or drug dependency or abuse (except for nicotine). Inability to handle the
 technological devices included in the study, for some other reason.