Background
Hypothesis and objectives of the study
Methods/design
Main characteristics of the study
Study design
Study area
Intervention
Description of the intervention
Telemonitored parameters | Established threshold values |
---|---|
Respiratory-rate | < 12 or >24 breaths per minute (bpm) |
Heart-rate | < 50 or >100 beats per minute (bpm) |
Systolic blood pressure | < 100 or >160 millimeters of mercury (mmHg) |
Diastolic blood pressure, | < 60 or >95 millimeters of mercury (mmHg) |
Oxygen saturation | < 95% (this is a frequently adjusted limit for patients with CLD) |
Temperature | > 37°C |
Weight | Should be notified if there is an increase of 1 Kg in three days |
Qualitative questionnaire | Negative answers to the questionnaire which correspond to: feeling worse, breathing difficulties, increased nocturia, oedema, worsening of cough, increased sputum production and a change in sputum colour |
Technical features of the system and devices for data transfer and reception
Study Population
Eligible patients
Exclusion criteria
Patient selection process
Randomisation
Recruitment of patients
Study variables
Initial assessment and baseline data
Outcome measures
Primary outcome measure | Secondary outcome measures | |
---|---|---|
Mortality
| - Mortality due to any cause | |
- Mortality due to HF or CLD | ||
Use of health care resources
| - Hospital admissions due to any cause |
- Hospital admissions due to HF or CLD |
- Duration of hospital stay | ||
- Emergency department visits | ||
- Home visits by GP or nurses | ||
- Visits to primary care centres by family or caregivers | ||
- Telephone contacts with professionals | ||
- Visits to specialist doctors | ||
Clinical efficacy
| - Worsening of the patients' pulmonary and/or heart condition (number of episodes) | |
Functional status and quality of life
| - Patient Quality of Life (EQ-5D questionnaire) | |
- Functional status (Barthel Index) | ||
- Caregiver burden (Zarit Burden Interview) | ||
Cost-effectiveness
| - Cost-effectiveness (using QALYs) | |
Satisfaction with the new technology
| - Degree of satisfaction of patients and health care professionals | |
Compliance
| - Patient and provider compliance with the telemonitoring |
1. Primary outcome measure
2. Secondary outcome measures
-
Number of emergency department visits for a cardiac or respiratory cause and for all causes.
-
Number of home visits (by their GP or nurse).
-
Number of primary care visits.
-
Number of telephone contacts with primary health care professionals.
-
Number of visits to the specialist doctors.