|- candidate number||8580|
|- NTR Number||NTR2592|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-okt-2010|
|- Secondary IDs||NL30930.008.10 CCMO|
|- Public Title||Integrated telemonitoring and telecare for patients with heart failure.|
|- Scientific Title||Integrated telemonitoring and telecare for patients with heart failure: A randomized controlled trial.|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Heart failure|
|- Inclusion criteria||Patients aged between 65-85 years with diagnosed heart failure according to the most recent guidelines, who live at home.|
|- Exclusion criteria||Patients with a history of severe psychiatric illness other than mood or anxiety disorders, with cognitive impairments (e.g. dementia) determined by the GP, with a terminal illness, with insufficient mastery of the Dutch language, or those who are illiterate or cannot read due to visual impairments, will be excluded. |
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2010|
|- planned closingdate||30-jun-2012|
|- Target number of participants||200|
|- Interventions||Patients will be randomized to care as usual or integrated telemonitoring and telecare for the duration of one year. |
Care as usual consists of regular care by a general practitioner, practice nurse and/or cardiologist.
The integrated telemonitoring and telecare consists of remote monitoring of blood pressure and weight and a social alarm which will be handled by a case manager on a call center. The integrated telemonitoring and telecare takes place in addition to care as usual.
|- Primary outcome||The primary outcome measure will be assessed by questionnaires at baseline, 3 6 and 12 months.|
|- Secondary outcome||Hospitalization and patient satisfaction assessed by questionnaires.|
|- Timepoints||Baseline, 3, 6 and 12 months.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| L. Ringoir|
|- CONTACT for SCIENTIFIC QUERIES||MD, PhD, Professor of Primary Care V.J.M. Pop|
|- Sponsor/Initiator ||University of Tilburg , POZOB|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background: |
Heart failure is a prevalent chronic disease with a poor prognosis and a large negative impact on quality of life. Due to the general rise in life expectancy and improved treatment options for cardiovascular disease, the incidence and prevalence of heart failure are expected to increase. Since heart failure is an important cause for hospitalization, prevention of exacerbation of symptoms is important in order to facilitate timely intervention and preserve quality of life. Telemonitoring of symptoms may be a feasible and effective method for managing the health of heart failure patients.
This randomized controlled trial will examine the effects of integrated telecare and telemonitoring of blood pressure and weight in 200 older primary care patients with heart failure compared to usual care. The main outcomes are quality of life and hospitalization. Quality of life will be assessed with questionnaires at baseline and after 3, 6 and 12 months.
Discussion and implications of the research:
This study will show if integrated telemonitoring and telecare is feasible and affects quality of life and hospital admissions of older patients with heart failure in primary care.
|- Main changes (audit trail)|
|- RECORD||23-okt-2010 - 19-nov-2010|