Early Assisted Discharge With Generic Community Nursing and Pulmonary Physicians vs Telemonitoring at Home for Chronic Obstructive Pulmonary Disease Exacerbations
Phase: NA
Conditions: COPD Exacerbation
Sponsor: Dr. López Viña

Early Assisted Discharge for COPD Exacerbations With 
Telemonitoring.  
 
 
 
 
ClinicalTrials.gov, NCT01951261. 
 
 
 
 
 
 
 
 
 
 
Versión 1. 01/02/2012 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Department Pneumology Hospital Puerta de Hierro and Carlos III Health 
Institute. 
 
 
Reseachers: Mario Pascual, Antolin Lopez Viña, Beatriz Cadavid, Patricia 
Mínguez.  

Protocol: 
 
The TELEMED-COPD study is a randomized clinical trial with 2 parallel groups 
(both with early discharge; intervention group: home hospitalization with 
telemonitoring / control group: traditional follow-up based on face-to-face visits 
by healthcare personnel). It was carried out at the Puerta de Hierro Hospital 
from March 2012 to July 2018. Once the informed consent was given by the 
participants, they were randomly distributed between the two groups using a 
table of pseudo-randomized numbers in variable blocks generated by computer. 
The randomization sequence was kept hidden by the randomization system 
itself. Substitution of patients withdrawn from the study was not performed. 
 
 
Participation criteria: 
 
Patient admitted with exacerbation of COPD in the Pulmonology Service, with 
no age limit and who, after an initial phase of clinical stabilization not exceeding 
4 days, meets the inclusion criteria: 1) Diagnosis of COPD (prior or during 
admission according to GOLD 2020), 2) absence of serious decompensated 
concomitant diseases, 3) arterial blood gas: pH> 7.35, pO2> 50 mmHg with O2 
at maximum 3 bpm, Oxygen saturation> 90%, pCO2 <55, 4) afebrile more than 
48 h, 5) need for administration of maximum bronchodilators every 6 hours, 6) 
corticosteroids <40mg / 12 hours, 7) chest radiograph without new onset 
pathology, 8) subjective improvement, and 9) adequate family environment. 
 
Exclusion criteria: 1) Neoplasms or other end-stage chronic diseases, 2) 
alcoholism, 3) need for intravenous medication, 4) inability to understand the 
program and participate in it, 5) have required ICU care or need mechanical 
ventilation non-invasive during exacerbation, 6) institutionalized patient. 
 
Withdrawal criteria: unsuccessful inability to use telemonitoring, complications 
derived from hospital admission or at the express request of the patient. 
 
 
Study variables: 
 

The main variable was the time to the first exacerbation after discharge 
(exacerbation was defined as an acute and sustained deterioration in the 
patient's clinical condition, greater than the daily fluctuation and requiring a 
change in the usual medication) 
The secondary variables analyzed were: the use of healthcare resources 
measured as the number of home visits by healthcare personnel (scheduled 
and unscheduled), average time hospitalized at home, exacerbations after 
discharge and readmissions for this reason. Other secondary variables: 
1)degree of satisfaction with home care (Satisfad questionnaire10) and for the 
intervention group also a specific survey, consisting of four questions with 
answers using a five-level Likert scale (assessment from 1 to 5, from lower to 
greater satisfaction and / or need for help) and a fifth open-ended question 
about their experience with the monitor. 2) Measurement of anxiety and 
depression using the STAI questionnaire (trait-trend) in the home hospitalization 
phase. 3) Impact on well-being and quality of life using the CAT (COPD 
Assessment Test) questionnaire. 4) Therapeutic compliance through the 
Morinsky-Green-Levine questionnaire at the beginning and at the sixth month; 
additionally for the intervention group, adherence to telemonitoring was 
determined based on compliance with the protocolized shipments. 
 
 
Comparative interventions: 
 
The first phase of the study was hospitalization at home (with or without 
telemonitoring depending on the assigned group) and the second phase was 
follow-up after medical discharge (identical for both groups, without 
telemonitoring); with one consultation a month and another at 6 months. In 
these consultations, outpatient and / or hospital exacerbations were collected, 
as well as other study variables. 
 
Control group (conventional home hospitalization): 
** Visiting regime: a first visit is made in the hospital (doctor and nurse who will 
follow up), making a clinical evaluation and management of the bronchodilators. 

The rest of the visits are daily at home and will initially be carried out only by the 
infirmary, except for the final visit in which the doctor accompanies him to 
discharge the patient, if he meets the following criteria: 
- Clinical stability, with recovery from daily activities, with dyspnea similar to its 
baseline. 
- Saturation levels> 90% with or without oxygen and lower requirements for 
short acting adrenergic beta2 agonists. 
- Correct use of medication. 
Constants are taken, physical examination, clinical evaluation and health 
education (involving knowledge of your disease, inhalation technique, 
therapeutic compliance, exercise respiratory, nutritional advice and smoking 
cessation if needed). 
 
Intervention group (Home Hospitalization with Telemedicine): 
** Regimen of home visits: 1) An initial visit to the hospital (doctor and nurse), 2) 
an intermediate visit by the nurse, 3) the last visit :discharged the patient by the 
nurse and the doctor. The nursing actions in the visits, the hours of attention 
and the discharge criteria are the same as those detailed in the control group. 
On the first day that the patient was at home, he received a visit from the 
technician, who installed the telemonitoring equipment and trained the patient 
and family members in its handling (leaving them a contact telephone number 
for incidents). 
** Telemonitoring: to carry it out, a multi-parameter recording equipment with 
communication capacity over the GSM network was used, which sent the data 
to an online web platform, which was reviewed by the responsible doctor. 
The parameters recorded were: ECG (leads I, II, III), O2 Saturation (%), heart 
rate, blood pressure, temperature and respiratory rate. 
The patient sent them twice a day (morning and afternoon), at approximately 
the same time (weekdays), and later received a phone call from the doctor to 
assess their clinical situation (symptoms, degree of dyspnea (mMRC), changes 
in appearance and amount of sputum, compliance and complications) and 
decide the action to follow. 
Thresholds of normal intervals were established in the before mentioned 
parameters, outside these ranges, a warning was generated in the form of sms 

to the medical phone. If an intervention was necessary, they contacted the 
patient and explained the action plan (home visit, going to the emergency room, 
changing medication, etc.). 
 
 
Statistic analysis: 
 
The main hypothesis is to verify that after the early discharge, the health results 
caused by the experimental treatment (intervention) are not inferior to the 
reference treatment (control). The scientific literature states that the median of 
the “exacerbation-free time” of the reference treatment is 2 months, and 
therefore, the “non-inferiority” condition requires that the median in the 
experimental group be similar. It is considered appropriate to set a 
“noninferiority” limit of 0.60 units in multiplicative terms with respect to the 
reference treatment; In other words, an attempt will be made to demonstrate 
that the experimental treatment provides at least a median of the exacerbation-
free time of not less than 1.2 months (36 days), if it is exacerbated before this 
period of time the study didn’t comply the “non inferiority” condition. Thus, we 
calculated that a minimum sample of 58 patients per treatment group (in total 
116) wasrequired to ensure a power of 80% and a significance level of 5%. 
Exacerbation-free time was defined as the interval between discharge from the 
home and the moment of exacerbation, until the end of the study when it did not 
occur or in the event of loss of follow-up until the last recorded time. All 
analyzes were performed according to the principle of intention to treat.  
The statistical analysis of the main variable was carried out using the Kaplan- 
Meier method and the statistical test of the log-rank test. 
The comparison between the two groups was made with the Student t test for 
continuous variables and the non-parametric Mann-Whitney test when the 
normality test was rejected. 
The statistical package used was Stata V.15.1.