Trial Outcomes & Findings for Early Assisted Discharge for COPD Exacerbations With Telemonitoring. (NCT NCT01951261)
NCT ID: NCT01951261
Last Updated: 2020-10-14
Results Overview
Time until the first exacerbation is the time that patient is stable before a new exacerbation and meaning a good control of the disease.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
116 participants
Primary outcome timeframe
Change from stable to exacerbation the first time at 6 month
Results posted on
2020-10-14
Participant Flow
Participant milestones
| Measure |
Telemonitoring and Telephone Control
Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.
Telemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.
|
Home Care
Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
58
|
|
Overall Study
Discontinued
|
9
|
6
|
|
Overall Study
COMPLETED
|
49
|
52
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
| Measure |
Telemonitoring and Telephone Control
Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.
Telemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.
|
Home Care
Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Protocol Violation
|
4
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Telemonitoring and Telephone Control
n=58 Participants
Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.
Telemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.
|
Home Care
n=58 Participants
Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 8 • n=58 Participants
|
70 years
STANDARD_DEVIATION 8 • n=58 Participants
|
69 years
STANDARD_DEVIATION 8 • n=116 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=58 Participants
|
23 Participants
n=58 Participants
|
36 Participants
n=116 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=58 Participants
|
35 Participants
n=58 Participants
|
80 Participants
n=116 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body mass index (BMI) (Mean (Standard Deviation)
|
27.1 Kg/m^2
STANDARD_DEVIATION 4 • n=58 Participants
|
26.5 Kg/m^2
STANDARD_DEVIATION 4 • n=58 Participants
|
26.8 Kg/m^2
STANDARD_DEVIATION 4 • n=116 Participants
|
PRIMARY outcome
Timeframe: Change from stable to exacerbation the first time at 6 monthPopulation: The overall number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module, because in the telemedicine group and the home care group, patients who readmission were not included, nor was the patient in whom the monitor did not work.
Time until the first exacerbation is the time that patient is stable before a new exacerbation and meaning a good control of the disease.
Outcome measures
| Measure |
Telemonitoring and Telephone Control
n=54 Participants
Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.
Telemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.
|
Home Care
n=55 Participants
Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).
|
|---|---|---|
|
Time Until the First Exacerbation
|
47 days
Interval 19.0 to 102.0
|
48 days
Interval 23.0 to 120.0
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration home care, an expected average of 7 daysInstrument that evaluates satisfaction with home care services in a self-administered. The score ranges from 0 to 30, with the worst value being zero and the best value being 30.
Outcome measures
| Measure |
Telemonitoring and Telephone Control
n=37 Participants
Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.
Telemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.
|
Home Care
n=42 Participants
Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).
|
|---|---|---|
|
SATISFAD 10
|
30 score on a scale
Interval 29.0 to 30.0
|
30 score on a scale
Interval 27.0 to 30.0
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of home care, an expected average of 7 daysPopulation: Not all study participants completed the test, so it does not correspond to the number of the flow chart.
The structure of the scale resulting from the combination of item polarity dimensions and the original two factors (State and Trait Anxiety). Minimum value 0, maximum value 120. Lower score indicates higher anxiety.
Outcome measures
| Measure |
Telemonitoring and Telephone Control
n=44 Participants
Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.
Telemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.
|
Home Care
n=44 Participants
Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).
|
|---|---|---|
|
State-Trait Anxiety Inventory (STAI)
State
|
15 score on a scale
Interval 10.0 to 26.0
|
17 score on a scale
Interval 12.0 to 25.0
|
|
State-Trait Anxiety Inventory (STAI)
Trait
|
20 score on a scale
Interval 15.0 to 26.0
|
23 score on a scale
Interval 17.0 to 27.5
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of home care up 24 weeksPopulation: Not all study participants completed the test, so it does not correspond to the number of the flow chart.
Consists of a series of 4 contrasting questions with answers dichotomous yes / no, reflecting the patient's behavior regarding compliance with medication. They are intended to assess whether the patient adopts correct attitudes regarding treatment for his illness; it is assumed that if attitudes they are incorrect the patient is non-compliant.
Outcome measures
| Measure |
Telemonitoring and Telephone Control
n=44 Participants
Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.
Telemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.
|
Home Care
n=41 Participants
Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).
|
|---|---|---|
|
Percentage of Participants With Medication Adherence Assessed Using Morinsky-Green-Levine Test
Initial
|
77 percentage of adherents
|
78 percentage of adherents
|
|
Percentage of Participants With Medication Adherence Assessed Using Morinsky-Green-Levine Test
At 6 month
|
86 percentage of adherents
|
87 percentage of adherents
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of home care, an expected average of 7 daysPopulation: In the home care group, patients did not send constants. Data from 55 patients were analyzed (2 readmissions and one patient in which the monitor failed were not included in the analysis)
It represents the compliance of the patients with respect to the sending of constants through the telemedicine monitor that should be (following the protocol) at least twice a day. The patient was considered compliant if he sent the constant at least 2 twice a day or non-compliant otherwise.
Outcome measures
| Measure |
Telemonitoring and Telephone Control
n=55 Participants
Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.
Telemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.
|
Home Care
Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).
|
|---|---|---|
|
Monitoring Compliance
|
2.23 sending of constant
Standard Deviation 1
|
—
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of home care, an expected average of 7 daysOutcome measures
| Measure |
Telemonitoring and Telephone Control
n=56 Participants
Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.
Telemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.
|
Home Care
n=57 Participants
Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).
|
|---|---|---|
|
Number of Home Visits
|
3.8 visits
Standard Deviation 1
|
5.1 visits
Standard Deviation 2
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of home care and up to 4 weeksPopulation: Not all study participants completed the test, so it does not correspond to the number of the flow chart.
It's a simple questionnaire for assessing and monitoring COPD. It quantifies chronic obstructive pulmonary disease (COPD) impact in routine practice to aid health status assessment. It's self-administered in 2 min. It consists of 8 items that measure aspects of cough, expectoration, chest tightness, dyspnea, domestic activities, self-confidence, sleep and energy. Each section is scored from 0 to 5 and therefore a maximum of 40 points can be obtained; a higher score indicates a greater negative impact of COPD. Significant clinical changes correspond to a variation of 2 points or more.
Outcome measures
| Measure |
Telemonitoring and Telephone Control
n=49 Participants
Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.
Telemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.
|
Home Care
n=49 Participants
Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).
|
|---|---|---|
|
COPD Assessment Test (CAT)
Initial
|
10 score on a scale
Interval 7.0 to 15.0
|
15 score on a scale
Interval 9.0 to 21.0
|
|
COPD Assessment Test (CAT)
At first month
|
8 score on a scale
Interval 5.0 to 15.0
|
8 score on a scale
Interval 4.5 to 11.0
|
Adverse Events
Telemonitoring and Telephone Control
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Home Care
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Telemonitoring and Telephone Control
n=58 participants at risk
Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.
Telemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.
|
Home Care
n=58 participants at risk
Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.7%
1/58 • During home follow-up until 6 months after the discharge.
All adverse events caused the patient to be hospitalized.
|
0.00%
0/58 • During home follow-up until 6 months after the discharge.
All adverse events caused the patient to be hospitalized.
|
|
Cardiac disorders
rapid atrial fibrillation
|
1.7%
1/58 • During home follow-up until 6 months after the discharge.
All adverse events caused the patient to be hospitalized.
|
0.00%
0/58 • During home follow-up until 6 months after the discharge.
All adverse events caused the patient to be hospitalized.
|
|
Respiratory, thoracic and mediastinal disorders
necrotizing pneumonia.
|
0.00%
0/58 • During home follow-up until 6 months after the discharge.
All adverse events caused the patient to be hospitalized.
|
1.7%
1/58 • During home follow-up until 6 months after the discharge.
All adverse events caused the patient to be hospitalized.
|
|
Musculoskeletal and connective tissue disorders
pain secondary to vertebral crushing
|
0.00%
0/58 • During home follow-up until 6 months after the discharge.
All adverse events caused the patient to be hospitalized.
|
1.7%
1/58 • During home follow-up until 6 months after the discharge.
All adverse events caused the patient to be hospitalized.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place