Heart Failure Clinical Trial
Official title:
Patient-centred Home-based Management of Heart Failure
A novel home-based tool for self-management is to be evaluated for heart failure patients. The tool assists the patient with symptom monitoring, education and titration of diuretics. Patients who were recently hospitalized for heart failure will be randomized to receiving the tool or standard care for six months. The primary end-point will be self-care behaviour, as measured with the validated instrument the European Heart failure self-care behaviour Scale 9-item questionnaire (Jaarsma et al). Secondary end-points are in-hospital days due to heart failure, quality of life (general and disease-specific) as measured by the SF-36 and KCCQ questionnaires, and finally knowledge about heart failure, assessed by the Dutch Heart Failure Knowledge Scale.
Patients who are admitted to the emergency unit for decompensated heart failure at the three
largest clinics in Stockholm, Sweden, are screened for recruitment. For patients to be
eligible for study participation, they shall be discharged from the hospital to the general
practitioner without being referred to a nurse led heart failure clinic, which is considered
the gold standard in terms of improving patients' self-care behaviour. At the point of
discharge, patients are approached about study participation and those who accept will be
provided study information and forced to provide a written consent to participate. Continuous
sampling is employed. Baseline characteristics are noted, as well as baseline data collected
for the following end-points: Self-care, using the European Heart Failure Self-care Behaviour
Scale (EHFScB), general quality of life using the SF-36 questionnaire, disease-specific
quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and knowledge about
heart failure using the Dutch Heart Failure Knowledge Scale (DHFKS). After this data is
collected patients will be randomized, using sealed envelopes, to either receive standard
care or receive the home-based tool that constitutes the intervention investigated. Within
one week after discharge, the patients randomized to the intervention group will have he tool
installed in their home.
The tool consists of a tablet computer locked to a specialized software, and a Bluetooth
connected weight scale. Every day the patient is encouraged by the tablet computer to step up
on the weight scale. The weight is wirelessly transferred to the tablet computer and today's
dose of diuretics is shown on screen together with a short tip about how to improve living
with heart failure. Every five days the patient assess their self-perceived symptoms, as
prompted on the tablet computer. For every patient equipped with the tool, a patient-specific
normal dose of diuretics, as well as a high dose is input in the tool at the point of
randomization. If the weight increases by 2kg or more in 3 days or less, the high dose is
recommended for two days, after which the effect on the weight is assessed. If the weight was
decreased back to where it was prior to the rapid weight gain, the dose is returned to normal
and if it is still elevated, the patient will be encouraged to call his/her health care
provider at the number presented on the table computer. If the self-assessed symptoms
deteriorate, the same type of warning will appear on screen, urging the patient to contact
the health care provider. Both the intervention patients and the control patients will be
given the same discharge information in writing, describing the most important parts of
self-management for heart failure patients. The data collected at baseline will be collected
again after 3 months and 6 months after randomization. After 6 months data about
hospitalizations will be retrieved from the medical records and adjudicated as either heart
failure-hospitalization or not. The adjudication will be done by the cardiologists
participating in the study and as the focus of the study is in estimating the net/marginal
incidence rate ratio of in-patient hospitalization, absorbing competing events (e.g. death)
will be handled by censoring.
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