Contact information
Type
Scientific
Primary contact
Dr Iñaki Martín Lesende
ORCID ID
Contact details
Comarca Bilbao de Atención Primaria
Gran Vía 62
2º
Bilbao
48011
Spain
+34 944 00 73 46
INAKI.MARTINLESENDE@osakidetza.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Evaluation of a primary care-based telemonitoring intervention for home care patients with heart failure and chronic lung disease: a randomised controlled trial
Acronym
TELBIL project
Study hypothesis
Home care patients with heart failure and chronic pulmonary disease may benefit from a primary care-based telemonitoring intervention which could result in a reduction of hospital admissions, duration of the hospitalisations and mortality. We postulate that home telemonitoring may improve the quality of life of these patients in a way that is cost-effective and acceptable to patients and health care professionals.
Ethics approval
Local Ethics Committee for Scientific Research (CEIC, Basurto Hospital, Bizkaia, Spain) approved on the 16th December 2009
Study design
Randomised controlled open clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Heart failure and chronic pulmonary disease
Intervention
Intervention group:
Telemonitoring will consist of daily patient self-measurements of respiratory rate, heart rate, blood pressure, transdermal oxygen saturation, weight and body temperature. Additionally, the patient will complete a qualitative symptom questionnaire daily using the telemonitoring system. After a local intelligent analysis the abnormal measurements, suggesting clinical alarm, will be sent by GPRS to the primary care team responsible for the care of each patient. Routine telephone contacts will be conducted every fortnight.
Control group:
Patients receive the standard care consisting of periodic medical examinations. The frequency of the medical examinations will vary depending on the clinical, social and family situation of each patient. In addition, the general practitioner or nurse will see or call the patient on demand in the event of a deterioration in the medical condition.
The physicians and nurses responsible for the care of the patients in the control and intervention groups have received specific training in the early detection and management of acute decompensations prior to the start of the study.
The total duration of intervention and follow-up for both intervention and control group is 12 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Measured at 3, 6, and 12 months:
1. Number and duration of hospital admissions
2. Mortality rate
3. Cost-effectiveness
Secondary outcome measures
Measured at 3, 6, and 12 months:
1. Number of emergency department visits
2. Number of home visits
3. Number of primary care visits
4. Number of specialist care visits
5. Number of telephone contacts
6. Number of acute heart or respiratory decompensations
7. Quality of life (EQ-5D questionnaire at baseline and after 3, 6 and 12 months of follow-up)
8. Patient and professional satisfaction with the telemonitoring technology using validated questionnaires (after 3 months of follow-up)
9. Medication changes
Overall trial start date
01/02/2010
Overall trial end date
01/06/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Home care patients aged over 70 years of any gender
2. Heart failure and/or chronic pulmonary disease
3. At least two hospital admissions during the previous year (with at least one of the admissions due to the above mentioned diseases)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60 - 80 participants (in total)
Participant exclusion criteria
1. Residents in nursing homes
2. Paediatric patients (younger than 14 years of age)
3. Refusal to participate in the study
4. Frequent users of specialist healthcare services (i.e., rehabilitation, haemodialysis, frequent visitors to hospital day-care centres, etc.)
5. Terminal illness with life expectancy less than 6 months
6. Cognitive impairment
Recruitment start date
01/02/2010
Recruitment end date
01/06/2011
Locations
Countries of recruitment
Spain
Trial participating centre
Comarca Bilbao de Atención Primaria
Bilbao
48011
Spain
Sponsor information
Organisation
Basque Government (Spain) - Department of Health and Consumer Affairs
Sponsor details
Donosti 1
Vitoria-Gazteiz
01010
Spain
jasua@ej-gv.es
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Basque Government (Spain) - Department of Health and Consumer Affairs
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23537332
Publication citations
-
Results
Martín-Lesende I, Orruño E, Bilbao A, Vergara I, Cairo MC, Bayón JC, Reviriego E, Romo MI, Larrañaga J, Asua J, Abad R, Recalde E, Impact of telemonitoring home care patients with heart failure or chronic lung disease from primary care on healthcare resource use (the TELBIL study randomised controlled trial)., BMC Health Serv Res, 2013, 13, 118, doi: 10.1186/1472-6963-13-118.