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Primary care-based telemonitoring for home care patients with heart failure and chronic lung disease
ISRCTN ISRCTN89041993
DOI 10.1186/ISRCTN89041993
ClinicalTrials.gov identifier
EudraCT number
Public title Primary care-based telemonitoring for home care patients with heart failure and chronic lung disease
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
Serial number at source N/A
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.
Lay summary Not provided at time of registration
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
Countries of recruitment Spain
Disease/condition/study domain Heart failure and chronic pulmonary disease
Participants - 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)
Participants - 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
Anticipated start date 01/02/2010
Anticipated end date 01/06/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 60 - 80 participants (in total)
Interventions 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.
Primary outcome measure(s) Measured at 3, 6, and 12 months:
1. Number and duration of hospital admissions
2. Mortality rate
3. Cost-effectiveness
Secondary outcome measure(s) 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
Sources of funding Basque Government (Spain) - Department of Health and Consumer Affairs
Trial website
Publications 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23537332
Contact name Dr  Iñaki  Martín Lesende
  Address Comarca Bilbao de Atención Primaria
Gran Vía 62, 2º
  City/town Bilbao
  Zip/Postcode 48011
  Country Spain
  Tel +34 944 00 73 46
  Fax +34 944 00 73 73
  Email INAKI.MARTINLESENDE@osakidetza.net
Sponsor Basque Government (Spain) - Department of Health and Consumer Affairs
  Address Donosti 1
  City/town Vitoria-Gazteiz
  Zip/Postcode 01010
  Country Spain
  Email jasua@ej-gv.es
Date applied 15/03/2010
Last edited 04/04/2013
Date ISRCTN assigned 20/04/2010
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