The aim of the study is to investigate to what extent telemonitoring is justifiable for patients with heart failure, with the focus on tailored care and substitution of care. The study will be carried out on three different institutions in the…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hospital admissions.
Health care related costs
Secondary outcome
Related at outcome:
· amount of planned and unplanned contacts with cardiologist, heart failure
nurse, cardiac emergency and general practitioner;
. amount of hospital admissions ( related and not related to heart failure)
· mortality (cardiac reason or not )
· costs related to hospital admissions and contacts with caregivers
Related at intervention:
· Compliance for drugs and non-medical regimen;
. State of health in terms of complaints ( tiredness and dyspnoea), risk
factors ( smoking, obesity, drink), instability, mobility, depression, self
efficacy and quality of live
Background summary
The application of E-Health creates several opportunities to improve the
quality of care in regard to the case management of patients with heart failure
in the Netherlands. In the United States this way of e-monitoring was already
tested on safety and feasibility, and currently positive results were also
shown in the Dutch setting. Based on the feasibility study the content of the
Health Buddy is adjusted recording to the recommendations of patients and
caregivers. In the current study the hypothesis is that telemonitoring results
in a decrease of hospital admissions, with equal quality of care defined as
mortality, quality of live and unplanned visits with caregivers. By this
telemonitoring is expected to be more cost effective than usual care in
patients with heart failure.
Study objective
The aim of the study is to investigate to what extent telemonitoring is
justifiable for patients with heart failure, with the focus on tailored care
and substitution of care. The study will be carried out on three different
institutions in the region South-Limburg. The following questions will be
answered:
Primary
1. To what extent does the use of the Health Buddy result in a decrease of
hospital admissions? 2. To what extent is the Health Buddy® more cost effective
than usual care? 3. To what extent will the amount of planned contacts decrease
without an increase of unplanned contacts? 4. Does the use of the Health Buddy
result in equal mortality rates compared with the control group?
Secundary
5. What is the effect of the Health Buddy® in patients with heart failure in
regard to drugs consumption and therapy compliance and level of knowledge, and
quality of live ? 6. To what extent is it possible to identify - based on
patientcharacteristics -a category patients showing divergent effects with
regard to care consumption, level of knowledge and compliance ? 7. To what
extent is there a relationship between symptoms, knowledge and behaviour?
Study design
The design of the study consists of a randomised - per hospital stratified-
controlled trial. Respondents will be recruited during 8 months at three
locations, i.e. the academic hospital Maastricht, Orbis Medical and Care
concern (Maaslandziekenhuis) and the Atrium Medical Centre.
390 respondents will be recruited. The follow up period is 12 months.
Intervention
Patients from the intervention group receive treatment and guidance based on
information acquired via the Health Buddy. That information will be obtained by
daily offered dialogues. These will take five minutes per day. On yearly basis
two contacts will be planned, respectively with the cardiologist and the heart
failure nurse.
Patients of the control group will receive care as usual in the participating
centres, according to the guidelines.
Newly diagnosed patients in the intervention and control group will receive
oral and written information as usual .
Study burden and risks
Completion of the dialogues takes five minutes daily. Quarterly patients
receive a questionnaire witch takes on average 40 minutes to complete. The
patients of the intervention group will have less face to face contacts with
the cardiologist and the heart failure nurse. This could result in a - by
specialists - undiagnosed worsening of heart failure.
Participation in this study is justified because patients will be asked daily
about their complaints and symptoms, allowing earlier adjustment of therapy and
prevent hospital admission.
Quarterly patients receive a questionnaire.
postbus 5800
6202 az Maastricht
Nederland
postbus 5800
6202 az Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
Patient > 18 years;
Patients with heart failure NYHA classification II-III-IV;
patient experienced a period of fluid retention;
Patient is treated by a cardiologist;
Patient is followed-up by a heart failure nurse;
Adequate level of the Dutch language;
Patient has an active telephone connection, preferably analogue ;
Patient is mental competent;
Patient has the disposal of a balance.
Exclusion criteria
Patients suffers from COPD, Gold classification 3 or 4
patient is a dialysis patient;
Patient has a visual restriction to read the dialogues on the Health Buddy;
Patient is hard of hearing or deaf;
Patient suffers from a lethal sickness with a prognosis < 1 year;
Patient participates in another trial;
Patient needs a hospital admission on short time, i.e. < 3 months;
Patient used the Health Buddy in an earlier stage;
Patient is an illiterate person.
Design
Recruitment
Medical products/devices used
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 | NL17061.068.07 |