Primary care-based telemonitoring for home care patients with heart failure and chronic lung disease

ISRCTN	ISRCTN89041993
DOI	https://doi.org/10.1186/ISRCTN89041993
Secondary identifying numbers	N/A

Submission date: 15/03/2010
Registration date: 20/04/2010
Last edited: 04/04/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Iñaki Martín Lesende
Scientific

Comarca Bilbao de Atención Primaria
Gran Vía 62, 2º
Bilbao
48011
Spain

Phone	+34 944 00 73 46
Email	INAKI.MARTINLESENDE@osakidetza.net

Study information

Study design	Randomised controlled open clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	TELBIL project
Study objectives	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(s)	Local Ethics Committee for Scientific Research (CEIC, Basurto Hospital, Bizkaia, Spain) approved on the 16th December 2009
Health condition(s) or problem(s) studied	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
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 study start date	01/02/2010
Completion date	01/06/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	60 - 80 participants (in total)
Key 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)
Key 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
Date of first enrolment	01/02/2010
Date of final enrolment	01/06/2011

Locations

Countries of recruitment

Spain

Study participating centre

Comarca Bilbao de Atención Primaria

Bilbao
48011
Spain

Sponsor information

Basque Government (Spain) - Department of Health and Consumer Affairs
Government

Donosti 1
Vitoria-Gazteiz
01010
Spain

Email	jasua@ej-gv.es
"ROR"	https://ror.org/00pz2fp31

Funders

Funder type

Government

Basque Government (Spain) - Department of Health and Consumer Affairs

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	28/03/2013		Yes	No