Integrated telemonitoring and telecare for patients with Heart Failure: A randomized controlled trial in primary care

Heart failure is an important cause of hospitalization, with acute heart
failure syndromes being the first cause of hospitalization for elderly people
in the USA and Europe. In addition, quality of life is lower for heart failure
patients compared to other cardiac patients, and patients with heart failure
report large numbers of distressing symptoms. This implies that delaying the
progression of heart failure by optimal treatment and adequate management of
symptoms may lead to health related quality of life benefits. In addition,
acute heart failure is the primary cause of hospitalization in elderly
patients, with acute heart failure mostly resulting from decompensated chronic
heart failure. Taken together, these findings suggest that prevention of
exacerbation of heart failure might reduce the risk of hospitalization.

Progression of heart failure is associated with hemodynamic changes which can
result in fluid retention and changes in blood pressure. Because the
progression of heart failure can lead to an exacerbation of the condition, it
is important to recognize changes in blood pressure and weight. Monitoring of
blood pressure can provide important information for care providers, may
improve patient compliance and may be used as a prognostic marker. In addition,
daily weighing and recognition of rapid weight gain are very important in
detecting a deterioration in the condition.

Telemonitoring can be used to assess and guard the clinical status of patients,
by using communication technology. A system with frequent monitoring can
facilitate early detection of deterioration in heart failure. Telemonitoring of
heart failure patients to track symptoms is a feasible method, as patient
acceptance is high. Moreover, a meta-analysis by Clark, Inglis et al. indicates
that telemonitoring reduces hospitalization and mortality. However, the effects
of telemonitoring on quality of life are unclear. Some studies have found a
significant beneficial effect of telemonitoring on health-related quality of
life while other studies found no effects on quality of life. However, only a
few RCTs studied quality of life as an outcome parameter.

The aim of the present study is to examine the effect of integrated
telemonitoring and telecare, compared to usual care, on quality of life and
hospitalization in patients with heart failure in primary care.

Primary
To examine the effect of integrated telecare and telemonitoring versus usual
care on quality of life in primary care patients with heart failure.

Secondary
To investigate the effect of integrated telecare and telemonitoring versus
usual care on hospitalization in patients with heart failure in primary care.

The study design is a randomized controlled trial, with randomization at
patient level. Assessments will take place at baseline (i.e., prior to
randomization), and at 3-, 6- and 12 months. Primary care patients with heart
failure (N=200) will be recruited from general practitioners (GP*s) affiliated
with the primary care organization Praktijkondersteuning Zuidoost Brabant
(POZOB).

The duration of the intervention will be 12 months. The integration of
telehealth and telecare consists of several elements:

Telehealth monitoring of symptoms of heart failure
Patients in the intervention group will receive a weighing scale and a blood
pressure monitor. They will be trained to monitor their weight and blood
pressure once a day at a set time. Data from the weighing scale and the blood
pressure monitor will be sent automatically every day to a case manager at a
call centre. For each patient, individual alert-values will be determined and
stored on a server. When the measured values cross the determined threshold,
the case manager will take action and call the patient. In case of a
life-threatening emergency, the ambulance will be called. If there is no
life-threatening emergency, the case manager will ask the patient to measure
again to eliminate errors. If there still is an alert, after medical triage,
the case manager will call either the GP or the NP for an appointment or a
visit to the patient*s home. All relevant alerts will be stored electronically
in the patient files at the call centre, and this information will be sent to
the GPs. In addition to alerts, the NP can also access an overview of the
telehealth data for a patient, and use the telehealth data for monitoring
symptoms of heart failure.

Case management
The second element of the intervention is the integration of social and medical
care. In contrast to the usual care group, patients in the intervention group
can contact the call centre 24 hours a day, 7 days a week. The call centre can
be contacted by phone or by pressing a social alarm button. In addition to
medical questions or issues, patients can also contact the call centre when
they need social services. Instead of one function (usual medical care during
evenings, nights and weekends), the call centre will provide three services:
1. Handling medical questions and concerns.
2. Arranging social services or answer questions about social services.
3. Handling social alarms.
This results in one integrated point of access for the patient for medical and
social assistance. In addition, a secure web-based system will allow easy
communication and access to patient records for case managers and NPs. This is
also linked to the GP system, with the GP always being the primary responsible
for the care provided.

The burden on patients of this study will be filling in a questionnaire 4 times
in 1 year. This means burden on patients is relatively low.

Since the intervention consists of an addition to regular care, consisting of
extra assistance and monitoring by use of modern communication technology,
risks of this study are estimated to be negligible.