Condition category
Circulatory System
Date applied
15/03/2010
Date assigned
20/04/2010
Last edited
04/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Iñaki Martín Lesende

ORCID ID

Contact details

Comarca Bilbao de Atención Primaria
Gran Vía 62

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 measures

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

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

Results - basic reporting

Publication summary

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23537332

Publication citations

  1. 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.

Additional files

Editorial Notes